Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03412747)

Last Updated: 2025-12-23

Results Overview

The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

478 participants

Primary outcome timeframe

Week 16

Results posted on

2025-12-23

Participant Flow

The study started to enroll patients in January 2018 and concluded in February 2020.

This study included 4 periods: a Screening Period (2 to 5 weeks), an Initial Treatment Period (16 weeks), a Maintenance Treatment Period (40 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the final dose of study drug). Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Bimekizumab 320 Milligrams (mg) Q4W/Q8W Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.	Bimekizumab 320 mg Q4W Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.	Adalimumab Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
Initial Treatment Period: Wk0-Wk16 STARTED	161	158	159
Initial Treatment Period: Wk0-Wk16 COMPLETED	154	153	150
Initial Treatment Period: Wk0-Wk16 NOT COMPLETED	7	5	9
Maintenance Treatment Period: Wk16-Wk24 STARTED	154	153	150
Maintenance Treatment Period: Wk16-Wk24 COMPLETED	149	152	149
Maintenance Treatment Period: Wk16-Wk24 NOT COMPLETED	5	1	1
Maintenance Treatment Period: Wk24-Wk56 STARTED	149	152	149
Maintenance Treatment Period: Wk24-Wk56 COMPLETED	143	143	133
Maintenance Treatment Period: Wk24-Wk56 NOT COMPLETED	6	9	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Bimekizumab 320 Milligrams (mg) Q4W/Q8W Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.	Bimekizumab 320 mg Q4W Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.	Adalimumab Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.
Initial Treatment Period: Wk0-Wk16 Adverse Event	2	2	3
Initial Treatment Period: Wk0-Wk16 Death	0	0	1
Initial Treatment Period: Wk0-Wk16 Lack of Efficacy	0	0	1
Initial Treatment Period: Wk0-Wk16 Protocol Violation	0	0	2
Initial Treatment Period: Wk0-Wk16 Lost to Follow-up	0	2	1
Initial Treatment Period: Wk0-Wk16 Withdrawal by Subject	4	1	1
Initial Treatment Period: Wk0-Wk16 Participant moved out of state	1	0	0
Maintenance Treatment Period: Wk16-Wk24 Adverse Event	3	1	0
Maintenance Treatment Period: Wk16-Wk24 Lack of Efficacy	1	0	0
Maintenance Treatment Period: Wk16-Wk24 Lost to Follow-up	0	0	1
Maintenance Treatment Period: Wk16-Wk24 Withdrawal by Subject	1	0	0
Maintenance Treatment Period: Wk24-Wk56 Adverse Event	3	4	6
Maintenance Treatment Period: Wk24-Wk56 Lack of Efficacy	0	1	1
Maintenance Treatment Period: Wk24-Wk56 Lost to Follow-up	0	2	5
Maintenance Treatment Period: Wk24-Wk56 Withdrawal by Subject	3	1	4
Maintenance Treatment Period: Wk24-Wk56 Moving out of town	0	1	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimekizumab 320 Milligrams (mg) Q4W/Q8W n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.	Bimekizumab 320 mg Q4W n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding.	Adalimumab n=159 Participants Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding.	Total Title n=478 Participants
Age, Categorical <=18 years	3 Participants n=68 Participants	0 Participants n=4 Participants	2 Participants n=219 Participants	5 Participants n=219 Participants
Age, Categorical Between 18 and 65 years	145 Participants n=68 Participants	147 Participants n=4 Participants	137 Participants n=219 Participants	429 Participants n=219 Participants
Age, Categorical >=65 years	13 Participants n=68 Participants	11 Participants n=4 Participants	20 Participants n=219 Participants	44 Participants n=219 Participants
Age, Continuous	44.0 years STANDARD_DEVIATION 13.5 • n=68 Participants	45.3 years STANDARD_DEVIATION 13.2 • n=4 Participants	45.5 years STANDARD_DEVIATION 14.3 • n=219 Participants	44.9 years STANDARD_DEVIATION 13.6 • n=219 Participants
Sex: Female, Male Female	49 Participants n=68 Participants	56 Participants n=4 Participants	45 Participants n=219 Participants	150 Participants n=219 Participants
Sex: Female, Male Male	112 Participants n=68 Participants	102 Participants n=4 Participants	114 Participants n=219 Participants	328 Participants n=219 Participants
Race/Ethnicity, Customized Asian	13 Participants n=68 Participants	10 Participants n=4 Participants	11 Participants n=219 Participants	34 Participants n=219 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=68 Participants	2 Participants n=4 Participants	2 Participants n=219 Participants	6 Participants n=219 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=68 Participants	1 Participants n=4 Participants	0 Participants n=219 Participants	3 Participants n=219 Participants
Race/Ethnicity, Customized White	140 Participants n=68 Participants	140 Participants n=4 Participants	141 Participants n=219 Participants	421 Participants n=219 Participants
Race/Ethnicity, Customized Other/Mixed	4 Participants n=68 Participants	5 Participants n=4 Participants	5 Participants n=219 Participants	14 Participants n=219 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The Randomized Set (RS) consisted of all randomized study participants. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=159 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	—	—	86.2 percentage of participants	47.2 percentage of participants

PRIMARY outcome

Timeframe: Week 16

The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline at Week 16.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=159 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16	—	—	85.3 percentage of participants	57.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The Randomized Set (RS) consisted of all randomized study participants. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20).

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) n=159 Participants Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With a PASI90 Response at Week 24	85.6 percentage of participants	51.6 percentage of participants	85.1 percentage of participants	86.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] with at least a two-category improvement from Baseline at Week 24.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) n=159 Participants Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24	86.5 percentage of participants	57.9 percentage of participants	87.0 percentage of participants	86.1 percentage of participants

SECONDARY outcome

Timeframe: Week 4

The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=159 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With a PASI75 Response at Week 4	—	—	76.5 percentage of participants	31.4 percentage of participants

SECONDARY outcome

Timeframe: Week 16

The PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=159 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With a PASI100 Response at Week 16	—	—	60.8 percentage of participants	23.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24

The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) n=319 Participants This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) n=159 Participants Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With a PASI100 Response at Week 24	66.8 percentage of participants	29.6 percentage of participants	65.8 percentage of participants	67.7 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ.

PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. Body divided into 4 areas: head/arms/trunk to groin/and legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of the psoriatic skin lesions multiplied by the involved psoriasis area score of the respective section and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, max score is 72=maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With a PASI90 Response at Week 56	—	—	82.6 percentage of participants	84.8 percentage of participants

SECONDARY outcome

Timeframe: Week 56

IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0=clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1=almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2=mild thickening, pink to light red coloration and predominately fine scaling, 3=moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4=severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\]/almost clear \[1\] with at least a 2-category improvement from Baseline at Wk56.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56	—	—	83.2 percentage of participants	82.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose of IMP.

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) n=159 Participants This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24	297.54 no. of new events per 100 subject-years Interval 244.77 to 358.31	—	310.44 no. of new events per 100 subject-years Interval 256.52 to 372.34	300.71 no. of new events per 100 subject-years Interval 247.6 to 361.83

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.

The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) n=159 Participants This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24	6.98 no. of new events per 100 subject-years Interval 2.27 to 16.3	—	1.37 no. of new events per 100 subject-years Interval 0.03 to 7.66	5.61 no. of new events per 100 subject-years Interval 1.53 to 14.38

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.

The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) n=159 Participants This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=161 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=158 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24	6.98 no. of new events per 100 subject-years Interval 2.27 to 16.29	—	8.30 no. of new events per 100 subject-years Interval 3.05 to 18.07	4.16 no. of new events per 100 subject-years Interval 0.86 to 12.17

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up Visit (up to Week 72)

Population: The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=154 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=468 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)	—	—	231.38 no. of new events per 100 subject-years Interval 191.68 to 276.88	262.41 no. of new events per 100 subject-years Interval 235.37 to 291.71

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up Visit (up to Week 72)

Population: The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=154 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=468 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)	—	—	7.03 no. of new events per 100 subject-years Interval 3.04 to 13.86	5.34 no. of new events per 100 subject-years Interval 3.05 to 8.67

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up Visit (up to Week 72)

Population: The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS).	Adalimumab (RS) Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W/Q8W (RS) n=154 Participants Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at prespecified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=468 Participants Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)	—	—	4.37 no. of new events per 100 subject-years Interval 1.42 to 10.19	4.62 no. of new events per 100 subject-years Interval 2.53 to 7.75

Adverse Events

Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS)

Serious events: 1 serious events

Other events: 65 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W Through Week 24 (SS)

Serious events: 4 serious events

Other events: 61 other events

Deaths: 0 deaths

Adalimumab Through Week 24 (SS)

Serious events: 5 serious events

Other events: 62 other events

Deaths: 1 deaths

Any Bimekizumab 320 mg Q8W (BKZ Set)

Serious events: 8 serious events

Other events: 60 other events

Deaths: 0 deaths

Any Bimekizumab 320 mg Q4W (BKZ Set)

Serious events: 16 serious events

Other events: 182 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) n=161 participants at risk Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).	Bimekizumab 320 mg Q4W Through Week 24 (SS) n=158 participants at risk Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.	Adalimumab Through Week 24 (SS) n=159 participants at risk Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.	Any Bimekizumab 320 mg Q8W (BKZ Set) n=154 participants at risk This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).	Any Bimekizumab 320 mg Q4W (BKZ Set) n=468 participants at risk This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
Eye disorders Retinal detachment	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/158 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/158 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Cellulitis	0.62% 1/161 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.64% 3/468 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Infected dermal cyst	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Nervous system disorders Carotid artery stenosis	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/158 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Renal and urinary disorders Calculus urinary	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/158 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Cardiac disorders Coronary artery stenosis	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Gastrointestinal disorders Pancreatitis	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Gastrointestinal disorders Gastric polyps	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Gastrointestinal disorders Umbilical hernia	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
General disorders Non-cardiac chest pain	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Hepatobiliary disorders Cholecystitis	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Immune system disorders Sarcoidosis	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Anal abscess	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Appendicitis	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Helicobacter infection	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Skin and subcutaneous tissue disorders Subcutaneous abscess	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Skin and subcutaneous tissue disorders Erysipelas	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Investigations Hepatic enzyme increased	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/154 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.21% 1/468 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Vascular disorders Hypertension	0.00% 0/161 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/158 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.65% 1/154 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/468 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).

Other adverse events

Other adverse events
Measure	Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) n=161 participants at risk Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).	Bimekizumab 320 mg Q4W Through Week 24 (SS) n=158 participants at risk Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.	Adalimumab Through Week 24 (SS) n=159 participants at risk Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.	Any Bimekizumab 320 mg Q8W (BKZ Set) n=154 participants at risk This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).	Any Bimekizumab 320 mg Q4W (BKZ Set) n=468 participants at risk This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set).
Gastrointestinal disorders Diarrhoea	3.1% 5/161 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	5.1% 8/158 • Number of events 9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	2.5% 4/159 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	3.2% 5/154 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	3.0% 14/468 • Number of events 16 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Nasopharyngitis	16.8% 27/161 • Number of events 40 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	20.3% 32/158 • Number of events 46 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	23.9% 38/159 • Number of events 50 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	18.2% 28/154 • Number of events 35 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	16.9% 79/468 • Number of events 113 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Oral candidiasis	11.8% 19/161 • Number of events 26 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	9.5% 15/158 • Number of events 20 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.00% 0/159 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	11.0% 17/154 • Number of events 26 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	14.1% 66/468 • Number of events 104 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Upper respiratory tract infection	7.5% 12/161 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	4.4% 7/158 • Number of events 8 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	9.4% 15/159 • Number of events 21 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	8.4% 13/154 • Number of events 16 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	6.4% 30/468 • Number of events 40 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Infections and infestations Pharyngitis	3.1% 5/161 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	2.5% 4/158 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	0.63% 1/159 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	7.1% 11/154 • Number of events 11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	2.8% 13/468 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
Vascular disorders Hypertension	5.6% 9/161 • Number of events 10 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	3.8% 6/158 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	8.2% 13/159 • Number of events 13 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	2.6% 4/154 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).	4.1% 19/468 • Number of events 20 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72) Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60