Trial Outcomes & Findings for Psoriatic Arthritis Study of Izokibep (NCT NCT05623345)
NCT ID: NCT05623345
Last Updated: 2025-05-23
Results Overview
ACR50 is a clinical trial measure for PsA, indicating a 50% improvement in symptoms. To qualify, participants must show a 50% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR50 is binary-patients either meet it or not.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
351 participants
Primary outcome timeframe
Week 16
Results posted on
2025-05-23
Participant Flow
A total of 351 participants with Psoriatic Arthritis (PsA) symptoms were recruited in Canada, United States, Bulgaria, Czech Republic, Germany, Hungary, Poland, and Spain between November 2022 and August 2024.
This study was divided into two Periods. In Period 1 (Phase 2b portion of the study), participants received either izokibep or placebo, until Week 16. Period 2 (Phase 3 portion of the study) lasted until Week 52. Participants who received placebo QW during Period 1 started receiving izokibep QW during Period 2 and participants who received izokibep during Period 1 continued to receive izokibep at the same dosing frequency in Period 2.
Participant milestones
| Measure |
Period 1: Placebo QW ; Period 2: Izokibep 160 mg QW
Participants received placebo as a subcutaneous (SC) injection QW for up to Week 16. Then, participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
|
Izokibep 80 mg Q4W
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
118
|
8
|
113
|
112
|
|
Overall Study
Completed Period 1
|
114
|
8
|
111
|
105
|
|
Overall Study
COMPLETED
|
64
|
4
|
57
|
52
|
|
Overall Study
NOT COMPLETED
|
54
|
4
|
56
|
60
|
Reasons for withdrawal
| Measure |
Period 1: Placebo QW ; Period 2: Izokibep 160 mg QW
Participants received placebo as a subcutaneous (SC) injection QW for up to Week 16. Then, participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
|
Izokibep 80 mg Q4W
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
0
|
9
|
20
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
7
|
2
|
|
Overall Study
Termination of Study By Sponsor
|
37
|
4
|
40
|
38
|
Baseline Characteristics
Psoriatic Arthritis Study of Izokibep
Baseline characteristics by cohort
| Measure |
Period 1: Placebo QW
n=118 Participants
Participants received placebo as a SC injection QW up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 Participants
Participants received izokibep 160 mg as a SC injection every Q2W up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 Participants
Participants received izokibep 160 mg as a SC injection QW up to Week 52.
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.6 Years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 9.40 • n=7 Participants
|
49.5 Years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
51.8 Years
STANDARD_DEVIATION 12.20 • n=4 Participants
|
51.6 Years
STANDARD_DEVIATION 12.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
185 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
315 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
110 participants
n=5 Participants
|
8 participants
n=7 Participants
|
108 participants
n=5 Participants
|
109 participants
n=4 Participants
|
335 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.
ACR50 is a clinical trial measure for PsA, indicating a 50% improvement in symptoms. To qualify, participants must show a 50% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR50 is binary-patients either meet it or not.
Outcome measures
| Measure |
Period 1: Placebo QW
n=118 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved 50% Improvement in American College of Rheumatology (ACR50) at Week 16
|
18 Participants
|
4 Participants
|
49 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses. Only participants with ≥ 3% BSA psoriasis at baseline were analyzed for this endpoint.
PASI is a tool used in clinical trials to measure the severity and extent of psoriasis. Scores range from a minimum of 0 to a maximum of 72, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Period 1: Placebo QW
n=60 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=5 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=64 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=59 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Baseline ≥ 3% Body Surface Area (BSA) Psoriasis Who Achieved a 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI90) at Week 16
|
7 Participants
|
3 Participants
|
37 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses. Only participants with LEI \> 0 at baseline were analyzed for this endpoint.
LEI is a clinical tool used to assess enthesitis in conditions like psoriatic arthritis and spondyloarthritis. It evaluates six sites: bilateral lateral epicondyles, medial femoral condyles, and achilles tendons. Each site is scored 0 (no pain) or 1 (pain on pressure), with a total score ranging from a minimum of 0 to a maximum of 6, where higher scores indicate more severe enthesitis.
Outcome measures
| Measure |
Period 1: Placebo QW
n=75 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=5 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=68 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=66 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Baseline Enthesitis > 0 With Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 16
|
35 Participants
|
4 Participants
|
38 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.
A participants was classified as being in MDA when at least five of the following seven criteria were met: * Tender joint count based on 68 joints (TJC68) ≤ 1 * Swollen joint count based on 66 joints (SJC66) ≤ 1 * PASI ≤ 1 or BSA ≤ 3% * Participant's Pain Assessment (Visual Analogue Scale \[VAS\]) ≤ 15 mm * Participant's Global Activity VAS ≤ 20 mm (corresponding to participant's Global Assessment of Disease Activity) * Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5 * Tender enthesitis points ≤ 1 out of 6 sites assessed by the LEI.
Outcome measures
| Measure |
Period 1: Placebo QW
n=118 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants Achieving Minimal Disease Activity (MDA) at Week 16
|
17 Participants
|
3 Participants
|
47 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.
ACR20 is a clinical trial measure for PsA, indicating a 20% improvement in symptoms. To qualify, participants must show a 20% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR20 is binary-patients either meet it or not.
Outcome measures
| Measure |
Period 1: Placebo QW
n=118 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants Achieving 20% Improvement in ACR (ACR20) at Week 16
|
41 Participants
|
6 Participants
|
72 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses. Only participants with PsAID ≥ 3 at baseline were analyzed for this endpoint.
The PsAID consists of nine items, each scored on a numeric rating scale (0-10), covering key aspects of disease burden, including pain, fatigue, skin problems, work/leisure activities, functional capacity, sleep disturbance, anxiety, coping, and social participation. The total score is calculated as a weighted sum of these individual items, with higher scores indicating a greater impact of the disease. The minimum score is 0 (no disease impact), while the maximum is 10 (worst possible disease impact). Reaching an improvement was considered an increase of 3 units from baseline score.
Outcome measures
| Measure |
Period 1: Placebo QW
n=98 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=7 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=102 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=105 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Baseline Psoriatic Arthritis Impact of Disease (PsAID) Score ≥ 3 With Improvement in PsAID Score at Week 16
|
12 Participants
|
3 Participants
|
43 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.
The HAQ-DI consists of 20 questions divided into eight categories: dressing, arising, eating, walking, hygiene, reaching, grip, and other activities. Each item is scored on a scale from 0 to 3, where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty, and 3 = unable to perform. The final HAQ-DI score is calculated as the average of the highest scores in each category, resulting in a range from 0 (no disability) to 3 (severe disability). Higher scores indicate greater functional impairment. A negative change indicates an improvement in functional impairment.
Outcome measures
| Measure |
Period 1: Placebo QW
n=114 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=106 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=103 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Change in Physical Function as Assessed by HAQ-DI From Baseline to Week 16
|
-0.14 Score on scale
Interval -0.23 to -0.06
|
-0.03 Score on scale
Interval -0.35 to 0.28
|
-0.30 Score on scale
Interval -0.39 to -0.21
|
-0.31 Score on scale
Interval -0.4 to -0.22
|
SECONDARY outcome
Timeframe: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuationPopulation: Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
An AE was any untoward medical occurrence in a participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received study treatment. Clinically significant changes in vital signs, electrocardiograms and laboratory tests recorded after treatment administration were documented as TEAEs. TEAEs were considered serious if they led to death, were life-threatening, required hospitalization or its prolongation, caused disability, resulted in congenital anomalies or were considered medically important. The events of special interest monitored were : candida infection; inflammatory bowel disease; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events (cerebrovascular accident and transient ischemic attack, nonfatal myocardial infarction or unstable angina, cardiovascular death); tuberculosis; infections (opportunistic, serious, or fungal); cytopenia; systemic hypersensitivity reactions.
Outcome measures
| Measure |
Period 1: Placebo QW
n=118 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and AE of Special Interest During Period 1
TEAEs
|
48 Participants
|
6 Participants
|
76 Participants
|
82 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and AE of Special Interest During Period 1
Serious TEAEs
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and AE of Special Interest During Period 1
AEs of Special Interest
|
2 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: First dose of study treatment on or after Week 16 up to Week 55Population: Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
An AE was any untoward medical occurrence in a participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received study treatment. Clinically significant changes in vital signs, electrocardiograms and laboratory tests recorded after treatment administration were documented as TEAEs. TEAEs were considered serious if they led to death, were life-threatening, required hospitalization or its prolongation, caused disability, resulted in congenital anomalies or were considered medically important. The events of special interest monitored were : candida infection; inflammatory bowel disease; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events (cerebrovascular accident and transient ischemic attack, nonfatal myocardial infarction or unstable angina, cardiovascular death); tuberculosis; infections (opportunistic, serious, or fungal); cytopenia; systemic hypersensitivity reactions.
Outcome measures
| Measure |
Period 1: Placebo QW
n=114 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=103 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=98 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced TEAEs, Serious TEAEs and AE of Special Interest During Period 2
TEAEs
|
89 Participants
|
5 Participants
|
67 Participants
|
67 Participants
|
|
Number of Participants Who Experienced TEAEs, Serious TEAEs and AE of Special Interest During Period 2
Serious TEAEs
|
4 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Experienced TEAEs, Serious TEAEs and AE of Special Interest During Period 2
AEs of Special Interest
|
3 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 65Population: ADA Analysis Set: Included all participants include who received at least one administration of izokibep and had both a baseline ADA measurement and at least one post-dose ADA measurement.
Blood samples were collected at different timepoints throughout the study. ADA is considered "Positive" if any titer value is available.
Outcome measures
| Measure |
Period 1: Placebo QW
n=116 Participants
Participants received placebo as SC injection QW for up to Week 16.
|
Izokibep 80 mg Q4W
n=8 Participants
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=108 Participants
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=108 Participants
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Baseline
|
56 Participants
|
4 Participants
|
57 Participants
|
54 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 2
|
56 Participants
|
3 Participants
|
61 Participants
|
54 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 4
|
56 Participants
|
4 Participants
|
58 Participants
|
55 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 12
|
53 Participants
|
2 Participants
|
55 Participants
|
51 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 16
|
54 Participants
|
6 Participants
|
57 Participants
|
57 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 24
|
40 Participants
|
5 Participants
|
70 Participants
|
75 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 36
|
62 Participants
|
7 Participants
|
67 Participants
|
76 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Week 52
|
65 Participants
|
7 Participants
|
63 Participants
|
68 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Follow-up Visit - Week 59
|
76 Participants
|
6 Participants
|
67 Participants
|
77 Participants
|
|
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
End of Study - Week 65
|
49 Participants
|
2 Participants
|
31 Participants
|
40 Participants
|
Adverse Events
Placebo QW - Period 1
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo/Izokibep 160 mg QW - Period 2
Serious events: 4 serious events
Other events: 65 other events
Deaths: 0 deaths
Izokibep 80 mg Q4W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Izokibep 160 mg Q2W
Serious events: 8 serious events
Other events: 78 other events
Deaths: 0 deaths
Izokibep 160 mg QW
Serious events: 4 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QW - Period 1
n=118 participants at risk
Participants received placebo as a SC injection QW for up to Week 16.
|
Placebo/Izokibep 160 mg QW - Period 2
n=114 participants at risk
Participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
|
Izokibep 80 mg Q4W
n=8 participants at risk
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 participants at risk
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 participants at risk
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Inflammation
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Device related infection
|
0.85%
1/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Periumbilical abscess
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Nervous system disorders
Wernicke-Korsakoff syndrome
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
Other adverse events
| Measure |
Placebo QW - Period 1
n=118 participants at risk
Participants received placebo as a SC injection QW for up to Week 16.
|
Placebo/Izokibep 160 mg QW - Period 2
n=114 participants at risk
Participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
|
Izokibep 80 mg Q4W
n=8 participants at risk
Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg Q2W
n=113 participants at risk
Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
|
Izokibep 160 mg QW
n=112 participants at risk
Participants received izokibep 160 mg as a SC injection QW for up to Week 52.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
6.1%
7/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
3.5%
4/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
2.7%
3/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Injection site erythema
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
46.5%
53/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
25.0%
2/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
46.0%
52/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
58.0%
65/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Injection site pruritus
|
0.85%
1/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
23.7%
27/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
25.0%
2/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
22.1%
25/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
25.9%
29/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Injection site swelling
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
11.4%
13/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
11.5%
13/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
11.6%
13/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Injection site pain
|
0.85%
1/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
7.0%
8/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
7.1%
8/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
7.1%
8/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Injection site rash
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
7.1%
8/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
2.7%
3/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Fatigue
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
6.2%
7/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
1.8%
2/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
General disorders
Swelling face
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.3%
14/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
15.9%
18/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
11.6%
13/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
4/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
5.3%
6/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
25.0%
2/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
8.8%
10/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
17.9%
20/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
COVID-19
|
1.7%
2/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
7.1%
8/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
3.6%
4/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Pharyngitis
|
0.85%
1/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
1.8%
2/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
1.8%
2/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Oral herpes
|
0.85%
1/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.88%
1/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.89%
1/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
2.7%
3/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
5.4%
6/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
1.8%
2/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
3.6%
4/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/118 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
0.00%
0/114 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
12.5%
1/8 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
7.1%
8/113 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
2.7%
3/112 • For Placebo QW - Period 1: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation. A TEAE that occurred before the first dose of study drug in Period 2 and is within 28 days after the end of study drug in Period 1 is assigned to Period 1. For Placebo/Izokibep 160 mg QW - Period 2: From Week 16 up to Week 55. For Izokibep 80 mg Q4W, Izokibep 160 mg Q2W, Izokibep 160 mg QW: Up to Week 55.
Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place