Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (NCT NCT04242498)
NCT ID: NCT04242498
Last Updated: 2025-11-06
Results Overview
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
509 participants
Primary outcome timeframe
Week 16
Results posted on
2025-11-06
Participant Flow
The study started to enroll participants in March 2020 and concluded in September 2022.
Participant Flow refers to the Randomized Set (RS) and Maintenance Set (MS).
Participant milestones
| Measure |
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Period: Week 0-16
STARTED
|
74
|
144
|
291
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
COMPLETED
|
69
|
133
|
262
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
NOT COMPLETED
|
5
|
11
|
29
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
STARTED
|
0
|
0
|
0
|
69
|
133
|
130
|
131
|
|
Maintenance Treatment Period: Week 16-48
COMPLETED
|
0
|
0
|
0
|
61
|
109
|
107
|
110
|
|
Maintenance Treatment Period: Week 16-48
NOT COMPLETED
|
0
|
0
|
0
|
8
|
24
|
23
|
21
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Period: Week 0-16
Adverse Event
|
1
|
1
|
9
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Lost to Follow-up
|
1
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Consent withdrawn by subject, not due to AE
|
2
|
8
|
12
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Subject Moved Long Distance From Clinic (Abroad)
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Withdrawn by investigator's decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period: Week 0-16
Randomized, not treated
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Adverse Event
|
0
|
0
|
0
|
0
|
7
|
6
|
4
|
|
Maintenance Treatment Period: Week 16-48
Lack of Efficacy
|
0
|
0
|
0
|
0
|
4
|
2
|
2
|
|
Maintenance Treatment Period: Week 16-48
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Maintenance Treatment Period: Week 16-48
Lost to Follow-up
|
0
|
0
|
0
|
2
|
3
|
1
|
2
|
|
Maintenance Treatment Period: Week 16-48
Consent withdrawn by subject, not due to AE
|
0
|
0
|
0
|
6
|
9
|
10
|
11
|
|
Maintenance Treatment Period: Week 16-48
Change In Address-Patient Not Wanting To Continue
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Treatment Period: Week 16-48
Visits Too Time-Consuming, Only SFU Will Be Done
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Maintenance Treatment Period: Week 16-48
Subject Relocated
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Total
n=509 Participants
Total of all reporting groups
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=291 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
7 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
482 Participants
n=50 Participants
|
70 Participants
n=49 Participants
|
135 Participants
n=50 Participants
|
277 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=50 Participants
|
4 Participants
n=49 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 12.4 • n=50 Participants
|
38.1 Years
STANDARD_DEVIATION 13.2 • n=49 Participants
|
35.2 Years
STANDARD_DEVIATION 11.9 • n=50 Participants
|
36.9 Years
STANDARD_DEVIATION 12.3 • n=50 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=50 Participants
|
31 Participants
n=49 Participants
|
77 Participants
n=50 Participants
|
150 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=50 Participants
|
43 Participants
n=49 Participants
|
67 Participants
n=50 Participants
|
141 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian
|
34 Participants
n=50 Participants
|
5 Participants
n=49 Participants
|
7 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black
|
40 Participants
n=50 Participants
|
5 Participants
n=49 Participants
|
13 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White
|
415 Participants
n=50 Participants
|
64 Participants
n=49 Participants
|
119 Participants
n=50 Participants
|
232 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
16 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
4 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
30 Participants
n=50 Participants
|
5 Participants
n=49 Participants
|
10 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
477 Participants
n=50 Participants
|
69 Participants
n=49 Participants
|
134 Participants
n=50 Participants
|
274 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The RS consisted of all study participants randomized into the study.
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=291 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
|
—
|
—
|
—
|
—
|
32.2 percentage of participants
Interval 21.4 to 42.9
|
53.8 percentage of participants
Interval 45.4 to 62.1
|
52.0 percentage of participants
Interval 46.1 to 57.8
|
SECONDARY outcome
Timeframe: Week 16Population: The RS consisted of all study participants randomized into the study.
HiSCR75 was defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=291 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
|
—
|
—
|
—
|
—
|
15.6 percentage of participants
Interval 7.2 to 24.0
|
33.7 percentage of participants
Interval 25.7 to 41.7
|
35.7 percentage of participants
Interval 30.1 to 41.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 16Population: The RS consisted of all study participants randomized into the study.
Flare was defined as a greater than or equal to (\>=) 25% increase in AN count with an absolute increase in AN count of \>= 2 relative to Baseline. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event prior to experiencing a flare were treated as having experienced a flare at all flare assessments on and after the intercurrent event date. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=291 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Flare by Week 16
|
—
|
—
|
—
|
—
|
28.0 percentage of participants
Interval 17.6 to 38.4
|
23.6 percentage of participants
Interval 16.5 to 30.7
|
28.8 percentage of participants
Interval 23.5 to 34.1
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The RS consisted of all study participants randomized into the study. Mean values shown do not account for model effects using the analysis of covariance (ANCOVA) model. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
The DLQI is a patient-reported questionnaire designed for use in adult participants with skin diseases and Hidradenitis Suppurativa (HS). The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL), with a recall period of 7 days. This instrument asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The scoring of each answer for the DLQI is on a scale range of 0 (not at all) to 3 (very much). The DLQI total score was calculated by adding the score of each question. The maximum score is 30, and the minimum score is 0. The higher the score, the more quality of life is impaired. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=291 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
—
|
—
|
—
|
—
|
-3.2 score on a scale
Standard Error 0.6
|
-4.7 score on a scale
Standard Error 0.5
|
-4.6 score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The RS consisted of all study participants randomized into the study. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Absolute change from Baseline in worst Skin Pain score at Week 16 was assessed using the worst skin pain item in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The worst skin pain score was derived from the weekly average of daily scores, defined as the sum of the scored item over the course of the study week divided by the number of days in which the item was completed, relative to each respective visit date. Intermittent missing data are imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data. Mean values shown do not account for model effects using the ANCOVA model.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=144 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=291 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Worst Skin Pain Score at Week 16
|
—
|
—
|
—
|
—
|
-0.36 score on a scale
Standard Error 0.30
|
-1.44 score on a scale
Standard Error 0.24
|
-1.83 score on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Week 16Population: The RS consisted of all study participants randomized into the study. Here, number of participants analyzed included RS with HSSDD worst skin pain score \>=3 at Baseline. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy.
Skin pain response at Week 16, as assessed by "worst skin pain" item in HSSDD, was defined as an improvement in weekly worst skin pain score of at least 3 points versus Baseline. Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Worst skin pain score was derived from weekly average of daily scores (sum of scored item over study week/number of days in which item completed, relative to each respective visit). Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Weekly pain scores were imputed and then dichotomized to obtain response status. Participants who experienced an intercurrent event were treated as non-responders following the intercurrent event. Percentages of participants shown do not account for model effects using logistic regression model.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=49 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=108 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=209 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Skin Pain Response at Week 16
|
—
|
—
|
—
|
—
|
10.9 percentage of participants
Interval 1.7 to 20.1
|
28.6 percentage of participants
Interval 19.5 to 37.8
|
31.8 percentage of participants
Interval 25.1 to 38.4
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] period).
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
n=69 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=133 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=130 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=131 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=142 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=290 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
71.0 percentage of participants
|
72.2 percentage of participants
|
77.7 percentage of participants
|
77.1 percentage of participants
|
56.8 percentage of participants
|
51.4 percentage of participants
|
64.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)Population: The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period).
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
n=69 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=133 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=130 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=131 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=142 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=290 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study
|
2.9 percentage of participants
|
3.0 percentage of participants
|
2.3 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
2.1 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 71)Population: The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs leading to discontinuation of the study are reported.
Outcome measures
| Measure |
Placebo/BKZ Dosing Regimen 2
n=69 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=133 Participants
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=130 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=131 Participants
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
Placebo
n=74 Participants
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=142 Participants
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=290 Participants
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
|
0 percentage of participants
|
4.5 percentage of participants
|
3.1 percentage of participants
|
1.5 percentage of participants
|
0 percentage of participants
|
2.1 percentage of participants
|
4.1 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
BKZ Dosing Regimen 1
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
BKZ Dosing Regimen 2
Serious events: 9 serious events
Other events: 101 other events
Deaths: 0 deaths
Placebo/BKZ Dosing Regimen 2
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
Serious events: 3 serious events
Other events: 57 other events
Deaths: 0 deaths
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=74 participants at risk
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=142 participants at risk
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=290 participants at risk
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=69 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=133 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=130 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=131 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.76%
1/131 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.75%
1/133 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
1/69 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.76%
1/131 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.69%
2/290 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.75%
1/133 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.77%
1/130 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.75%
1/133 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
1/69 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.77%
1/130 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Bartholinitis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.76%
1/131 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.76%
1/131 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.75%
1/133 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.75%
1/133 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Psychiatric disorders
Depression
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.77%
1/130 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.76%
1/131 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/69 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/133 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/130 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/131 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
Other adverse events
| Measure |
Placebo
n=74 participants at risk
Participants received placebo during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 1
n=142 participants at risk
Participants received Bimekizumab (BKZ) dosing regimen 1 subcutaneously (SC) during the 16-weeks Initial Treatment Period.
|
BKZ Dosing Regimen 2
n=290 participants at risk
Participants received BKZ dosing regimen 2 SC during the 16-weeks Initial Treatment Period.
|
Placebo/BKZ Dosing Regimen 2
n=69 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to placebo received BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 1/BKZ Dosing Regimen 1
n=133 participants at risk
After the 16-weeks Initial Treatment Period, participants initially randomized to BKZ dosing regimen 1 continued to receive BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 1
n=130 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 received BKZ dosing regimen 1 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
BKZ Dosing Regimen 2/BKZ Dosing Regimen 2
n=131 participants at risk
After the 16-week Initial Treatment Period, participants initially randomized to BKZ dosing regimen 2 continued to receive BKZ dosing regimen 2 SC during the 32-weeks Maintenance Treatment Period (up to Week 48).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
6/74 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.5%
5/142 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
18/290 • Number of events 21 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.9%
2/69 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.5%
6/133 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
4/130 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.3%
3/131 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.5%
5/142 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.3%
24/290 • Number of events 26 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.3%
3/69 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.3%
11/133 • Number of events 13 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
12.3%
16/130 • Number of events 18 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
10.7%
14/131 • Number of events 17 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.6%
8/142 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.34%
1/290 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
1/69 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
2/133 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.3%
3/130 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.3%
3/131 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Nervous system disorders
Headache
|
9.5%
7/74 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.9%
7/142 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
18/290 • Number of events 21 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.3%
3/69 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.3%
7/133 • Number of events 10 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
4/130 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.3%
7/131 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
6.8%
5/74 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
9.2%
13/142 • Number of events 15 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
7.9%
23/290 • Number of events 27 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
10.1%
7/69 • Number of events 11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
12.0%
16/133 • Number of events 19 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
18.5%
24/130 • Number of events 33 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
11.5%
15/131 • Number of events 15 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.1%
3/142 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.8%
11/290 • Number of events 11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.9%
2/69 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.5%
6/133 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.2%
8/130 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
8.4%
11/131 • Number of events 15 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.5%
5/142 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.8%
8/290 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.9%
2/69 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.8%
5/133 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
4.6%
6/130 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.9%
9/131 • Number of events 11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/74 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.1%
3/142 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.8%
11/290 • Number of events 11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.8%
4/69 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
2/133 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.4%
7/130 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
6.1%
8/131 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Rhinitis
|
1.4%
1/74 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/290 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.4%
1/69 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.75%
1/133 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.5%
2/130 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.3%
7/131 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/74 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.00%
0/142 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
1.7%
5/290 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.8%
4/69 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.3%
7/133 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.8%
5/130 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.3%
3/131 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/74 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
0.70%
1/142 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.1%
9/290 • Number of events 10 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
5.8%
4/69 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.8%
5/133 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
3.8%
5/130 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
2.3%
3/131 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs were analyzed and reported for Initial Treatment Period (SS) and Maintenance Treatment Period (MS) separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60