Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (NCT NCT05314517)
NCT ID: NCT05314517
Last Updated: 2025-09-12
Results Overview
Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (oral corticosteroids \[OCS\] taper/immunosuppressive therapy \[IST\] removal/prohibited medication). Participants with premature treatment discontinuation in the DB period without rescue event were considered as with missing rescue event status and excluded from analysis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.
Results posted on
2025-09-12
Participant Flow
The study included a double-blind (DB) period and an open-label extension (OLE) period.
Participant milestones
| Measure |
Namilumab
Participants received namilumab subcutaneously (SC) on Day 1, Day 15 (Week 2), and then every 4 weeks (Q4W) thereafter through Week 22.
|
Placebo
Participants received placebo matched to namilumab dosing through Week 22.
|
Namilumab to Namilumab
Participants who previously received namilumab in the double-blind period received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
Placebo to Namilumab
Participants who previously received placebo in the double-blind period received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
|---|---|---|---|---|
|
Double-blind Period
STARTED
|
53
|
54
|
0
|
0
|
|
Double-blind Period
Safety Population
|
52
|
54
|
0
|
0
|
|
Double-blind Period
Modified Intent-to-treat (mITT) Population
|
49
|
51
|
0
|
0
|
|
Double-blind Period
COMPLETED
|
48
|
53
|
0
|
0
|
|
Double-blind Period
NOT COMPLETED
|
5
|
1
|
0
|
0
|
|
Open-label Extension
STARTED
|
0
|
0
|
47
|
49
|
|
Open-label Extension
Safety Population
|
0
|
0
|
47
|
49
|
|
Open-label Extension
COMPLETED
|
0
|
0
|
30
|
29
|
|
Open-label Extension
NOT COMPLETED
|
0
|
0
|
17
|
20
|
Reasons for withdrawal
| Measure |
Namilumab
Participants received namilumab subcutaneously (SC) on Day 1, Day 15 (Week 2), and then every 4 weeks (Q4W) thereafter through Week 22.
|
Placebo
Participants received placebo matched to namilumab dosing through Week 22.
|
Namilumab to Namilumab
Participants who previously received namilumab in the double-blind period received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
Placebo to Namilumab
Participants who previously received placebo in the double-blind period received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
|---|---|---|---|---|
|
Double-blind Period
Adverse Event
|
4
|
0
|
0
|
0
|
|
Double-blind Period
Noncompliance
|
0
|
1
|
0
|
0
|
|
Double-blind Period
Randomized, not treated
|
1
|
0
|
0
|
0
|
|
Open-label Extension
Adverse Event
|
0
|
0
|
1
|
2
|
|
Open-label Extension
Investigator decision
|
0
|
0
|
1
|
0
|
|
Open-label Extension
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Open-label Extension
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
|
Open-label Extension
Use of prohibited medication
|
0
|
0
|
1
|
0
|
|
Open-label Extension
Sponsor decision to terminate study
|
0
|
0
|
13
|
15
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
Baseline characteristics by cohort
| Measure |
Namilumab
n=52 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=54 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 12.13 • n=93 Participants
|
54.1 years
STANDARD_DEVIATION 10.35 • n=4 Participants
|
52.9 years
STANDARD_DEVIATION 11.27 • n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.Population: mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants with rescue event status.
Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (oral corticosteroids \[OCS\] taper/immunosuppressive therapy \[IST\] removal/prohibited medication). Participants with premature treatment discontinuation in the DB period without rescue event were considered as with missing rescue event status and excluded from analysis.
Outcome measures
| Measure |
Namilumab
n=48 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=51 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
|---|---|---|
|
Percentage of Participants With a Rescue Event During the DB Period
|
37.5 percentage of participants
Interval 27.0 to 49.4
|
23.5 percentage of participants
Interval 15.2 to 34.5
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: The mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
FVC is the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Percent of predicted FVC = (actual FVC measurement)/(predicted value of FVC) \* 100. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measure (MMRM).
Outcome measures
| Measure |
Namilumab
n=49 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=51 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
|---|---|---|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26
|
-3.28 percentage of predicted FVC
Standard Error 1.058
|
-2.92 percentage of predicted FVC
Standard Error 0.967
|
SECONDARY outcome
Timeframe: Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.Population: mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event.
Time of first rescue event was defined as the time from randomization to the rescue event date. Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (OCS taper/IST removal/prohibited medication). Data was calculated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Namilumab
n=49 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=51 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
|---|---|---|
|
Time to the First Rescue Event During the DB Period
|
11.0 weeks
Interval 1.0 to 26.6
|
12.86 weeks
Interval 3.0 to 22.1
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: The mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants with OCS \>5 mg/day at baseline.
Percentage of participants achieving OCS taper (achieving OCS dose ≤5 milligrams \[mg\] at end of Week 10 \[Day 77\] for participants with baseline OCS \>10 mg/day, achieving ≤ 5 mg at end of Week 6 \[Day 49\] for participants with baseline OCS \>5 to ≤10 mg/day) without any rescue event during the DB period for participants with OCS \>5 mg/day at baseline are reported.
Outcome measures
| Measure |
Namilumab
n=15 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=13 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
|---|---|---|
|
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period
|
53.3 percentage of participants
Interval 33.3 to 72.3
|
76.9 percentage of participants
Interval 54.2 to 90.4
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: The mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The KSQ has 29 questions (items 1 to 16, and items 26-38). The KSQ Lung domain score was calculated based on items 11 to 16. Each item was answered on a 7-point scale where 1 means the participant experienced symptoms all the time and 7 means the participant did not experience the symptom at all. The raw item scores were first converted into item re-scores using the first conversion step. Then, the re-scores for the 6 items were totaled and the total converted into the logit 1 (worst symptom) - 100 (no symptom) score, where higher score indicating better health. LS mean and SE were calculated using MMRM.
Outcome measures
| Measure |
Namilumab
n=47 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=49 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
|---|---|---|
|
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26
|
1.61 units on a scale
Standard Error 1.866
|
3.47 units on a scale
Standard Error 1.771
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: Safety population included all randomized participants who received any amount of study treatment.
An adverse event (AE) was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. TEAEs are those AEs with start date on or after the start date of treatment through the earlier of 18-week post last dose during DB period or prior to first dose during OLE period, whichever was earlier. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Namilumab
n=52 Participants
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=54 Participants
Participants received placebo matched to namilumab dosing through Week 22.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period
|
49 Participants
|
51 Participants
|
Adverse Events
Namilumab
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Namilumab to Namilumab
Serious events: 7 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo to Namilumab
Serious events: 5 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Namilumab
n=52 participants at risk
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=54 participants at risk
Participants received placebo matched to namilumab dosing through Week 22.
|
Namilumab to Namilumab
n=52 participants at risk
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
Participants then received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
Placebo to Namilumab
n=49 participants at risk
Participants who previously received placebo in the double-blind period received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Seizure
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
Other adverse events
| Measure |
Namilumab
n=52 participants at risk
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
|
Placebo
n=54 participants at risk
Participants received placebo matched to namilumab dosing through Week 22.
|
Namilumab to Namilumab
n=52 participants at risk
Participants received namilumab SC on Day 1, Day 15 (Week 2), and then Q4W thereafter through Week 22.
Participants then received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
Placebo to Namilumab
n=49 participants at risk
Participants who previously received placebo in the double-blind period received namilumab SC at week 26 and then Q4W thereafter through Week 50.
|
|---|---|---|---|---|
|
Infections and infestations
Gastrointestinal bacterial infection
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Oral candidiasis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
20.4%
11/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
23.1%
12/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
20.4%
10/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
6/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
17.3%
9/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Bronchitis
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
6.1%
3/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Influenza
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
6.1%
3/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Urinary tract infection
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
COVID-19
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
11.5%
6/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Rhinitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Borrelia infection
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Bronchitis haemophilus
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Chronic sinusitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Conjunctivitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Ear infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Eye infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Pericoronitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Rash pustular
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Tooth abscess
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Viral infection
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Blood and lymphatic system disorders
Monocytosis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Immune system disorders
Seasonal allergy
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Immune system disorders
Drug hypersensitivity
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Sleep disorder
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
8.2%
4/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Mood altered
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Headache
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
10.2%
5/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Dizziness
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
11.5%
6/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Essential tremor
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Restless legs syndrome
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Small fibre neuropathy
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Cataract
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Visual impairment
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Conjunctival deposit
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Dry eye
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Hypermetropia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Macular degeneration
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Myopia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Photophobia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Retinal tear
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Swelling of eyelid
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Vision blurred
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Visual field defect
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Palpitations
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Vascular disorders
Hot flush
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Vascular disorders
Hypertensive urgency
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
12/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
27.8%
15/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
36.5%
19/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
18.4%
9/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
10/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
18.5%
10/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
23.1%
12/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
10.2%
5/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
13.5%
7/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
25.0%
13/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
32.7%
16/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
11.5%
6/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Larynx irritation
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hyperinflation
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
11.5%
6/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
6.1%
3/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
13.5%
7/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
6.1%
3/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Food poisoning
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Tongue ulceration
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Hepatobiliary disorders
Liver sarcoidosis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
6.1%
3/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Cutaneous sarcoidosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Ephelides
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.3%
9/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
23.1%
12/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.4%
4/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
11.5%
6/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.4%
1/29 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/32 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.4%
1/29 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/29 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Reproductive system and breast disorders
Dyspareunia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Fatigue
|
19.2%
10/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
11.1%
6/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
23.1%
12/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
10.2%
5/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site pain
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
9.6%
5/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Chills
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.6%
3/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site reaction
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site erythema
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Asthenia
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site haematoma
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Chest pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Influenza like illness
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
10.2%
5/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site rash
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Facial pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Feeling hot
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site bruising
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site paraesthesia
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site pruritus
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site swelling
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injection site warmth
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Injury associated with device
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Peripheral swelling
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Hepatic enzyme increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Glomerular filtration rate decreased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Surfactant protein increased
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Weight decreased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood creatinine increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
7.7%
4/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood glucose increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood uric acid increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Eosinophil count increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Forced vital capacity decreased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Glycosylated haemoglobin increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Haematocrit increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Heart rate increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
High density lipoprotein increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Hysteroscopy
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Influenza A virus test positive
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Intraocular pressure increased
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Lung diffusion test decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Stool analysis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Transaminases increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
5.8%
3/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.7%
2/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Complications of transplanted lung
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Environmental exposure
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Tattoo associated skin reaction
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Dry mouth
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Crystal urine present
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Lethargy
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Localised infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Emotional poverty
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Dementia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Migraine
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Nervous system disorders
Sedation
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Glaucoma
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Childhood asthma
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Shoulder girdle pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
General disorders
Vaccination site pain
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
4.1%
2/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
3.8%
2/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Bacterial test positive
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Band neutrophil count increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood creatine increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood potassium increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Full blood count decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Oxygen consumption increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Platelet count increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Pulmonary function test abnormal
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Pulmonary function test increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Investigations
Weight increased
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
0.00%
0/54 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
1.9%
1/52 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
2.0%
1/49 • From first dose to 18 weeks after last dose (up to 68 weeks)
Safety population included all randomized participants who received any amount of study treatment. Per protocol, the Safety on-namilumab population (namilumab to namilumab) included all randomized participants who received any amount of namilumab during the DB or OLE period. Each arm includes all AEs in randomized participants from first dose of namilumab in DB or OLE period until 18 weeks after last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place