Trial Outcomes & Findings for A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03410992)

Results Overview

A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

435 participants

Primary outcome timeframe

At Week 16

Results posted on

2025-12-23

Participant Flow

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

Study has a 2-5 weeks Screening Period, a 16 weeks Initial Period, a 40 weeks Randomized-Withdrawal Period (RWP) and a SFU Period (20 weeks after final dose). Participants who did not achieve a PASI90 response at Wk16 or who relapsed at Wk20/later during the RWP, entered 12 weeks of escape treatment. Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Bimekizumab 320 mg Q4W Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Placebo/Placebo Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.	Bimekizumab 320 mg Q4W/Placebo Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.	Bimekizumab 320 mg Q4W/Q8W Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period.	Placebo Escape Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Bimekizumab 320 mg Q4W Escape Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Bimekizumab 320 mg Q4W/ Placebo Escape Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Placebo Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Bimekizumab 320 mg Q4W/Q8W Escape Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
Initial Treatment Period: up to Wk16 STARTED	349	0	0	0	0	0	0	0	86	0	0
Initial Treatment Period: up to Wk16 COMPLETED	340	0	0	0	0	0	0	0	82	0	0
Initial Treatment Period: up to Wk16 NOT COMPLETED	9	0	0	0	0	0	0	0	4	0	0
Week 16 Assessment STARTED	340	0	0	0	0	0	0	0	82	0	0
Week 16 Assessment Received Escape Treatment	23	0	0	0	0	0	0	0	81	0	0
Week 16 Assessment COMPLETED	311	0	0	0	0	0	0	0	1	0	0
Week 16 Assessment NOT COMPLETED	29	0	0	0	0	0	0	0	81	0	0
Randomized-Withdrawal Period: up to Wk56 STARTED	0	1	105	100	106	0	0	0	0	0	0
Randomized-Withdrawal Period: up to Wk56 Received Escape Treatment	0	0	67	4	7	0	0	0	0	0	0
Randomized-Withdrawal Period: up to Wk56 COMPLETED	0	1	33	93	94	0	0	0	0	0	0
Randomized-Withdrawal Period: up to Wk56 NOT COMPLETED	0	0	72	7	12	0	0	0	0	0	0
Escape Treatment: 12 Weeks STARTED	0	0	0	0	0	81	23	67	0	4	7
Escape Treatment: 12 Weeks COMPLETED	0	0	0	0	0	81	22	66	0	4	7
Escape Treatment: 12 Weeks NOT COMPLETED	0	0	0	0	0	0	1	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Bimekizumab 320 mg Q4W Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Bimekizumab 320 mg Q4W/Placebo Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.	Bimekizumab 320 mg Q4W/Q8W Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period.	Bimekizumab 320 mg Q4W Escape Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Bimekizumab 320 mg Q4W/ Placebo Escape Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Placebo Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
Initial Treatment Period: up to Wk16 Adverse Event	5	0	0	0	0	0	0
Initial Treatment Period: up to Wk16 Lack of Efficacy	1	0	0	0	0	0	2
Initial Treatment Period: up to Wk16 Lost to Follow-up	3	0	0	0	0	0	1
Initial Treatment Period: up to Wk16 Withdrawal by Subject	0	0	0	0	0	0	1
Week 16 Assessment PASI90 Non-Response at Week 16	23	0	0	0	0	0	81
Week 16 Assessment Incorrect escapers	6	0	0	0	0	0	0
Randomized-Withdrawal Period: up to Wk56 Adverse Event	0	3	2	0	0	0	0
Randomized-Withdrawal Period: up to Wk56 Lost to Follow-up	0	2	1	2	0	0	0
Randomized-Withdrawal Period: up to Wk56 Withdrawal by Subject	0	0	0	3	0	0	0
Randomized-Withdrawal Period: up to Wk56 Relapse at Week 20 or later	0	67	4	7	0	0	0
Escape Treatment: 12 Weeks Adverse Event	0	0	0	0	1	0	0
Escape Treatment: 12 Weeks Withdrawal by Subject	0	0	0	0	0	1	0

Baseline Characteristics

A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period 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	Placebo n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Bimekizumab 320 mg Q4W n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.	Total Title n=435 Participants
Age, Categorical <=18 years	2 Participants n=68 Participants	1 Participants n=4 Participants	3 Participants n=219 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=68 Participants	327 Participants n=4 Participants	407 Participants n=219 Participants
Age, Categorical >=65 years	4 Participants n=68 Participants	21 Participants n=4 Participants	25 Participants n=219 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 13.1 • n=68 Participants	44.5 years STANDARD_DEVIATION 12.9 • n=4 Participants	44.3 years STANDARD_DEVIATION 12.9 • n=219 Participants
Sex: Female, Male Female	28 Participants n=68 Participants	94 Participants n=4 Participants	122 Participants n=219 Participants
Sex: Female, Male Male	58 Participants n=68 Participants	255 Participants n=4 Participants	313 Participants n=219 Participants
Race/Ethnicity, Customized Asian	5 Participants n=68 Participants	13 Participants n=4 Participants	18 Participants n=219 Participants
Race/Ethnicity, Customized Black	0 Participants n=68 Participants	6 Participants n=4 Participants	6 Participants n=219 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=68 Participants	2 Participants n=4 Participants	2 Participants n=219 Participants
Race/Ethnicity, Customized White	79 Participants n=68 Participants	324 Participants n=4 Participants	403 Participants n=219 Participants
Race/Ethnicity, Customized Other/mixed	2 Participants n=68 Participants	4 Participants n=4 Participants	6 Participants n=219 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: The Randomized Set (RS) consisted of all randomized study participants.

A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	—	—	1.2 percentage of participants	90.8 percentage of participants	—

PRIMARY outcome

Timeframe: At Week 16

Population: e Randomized Set (RS) consisted of all randomized study participants.

The Investigator's Global Assessment (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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16	—	—	1.2 percentage of participants	92.6 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 16

Population: The Randomized Set (RS) consisted of all randomized study participants.

A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a PASI100 Response at Week 16	—	—	1.2 percentage of participants	68.2 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 16

Population: The Randomized Set (RS) consisted of all randomized study participants.

The Investigator's Global Assessment (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 with at least \>= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a IGA Clear Response at Week 16	—	—	1.2 percentage of participants	69.6 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 4

Population: The Randomized Set (RS) consisted of all randomized study participants.

A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-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, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a PASI75 Response at Week 4	—	—	1.2 percentage of participants	75.9 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 16

Population: The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.

As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=67 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=255 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16	—	—	9.0 percentage of participants	78.8 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 16

Population: The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.

A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=72 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=278 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16	—	—	5.6 percentage of participants	75.5 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 16

Population: The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.

As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=70 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=286 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16	—	—	5.7 percentage of participants	78.0 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 16

Population: The Randomized Set (RS) consisted of all randomized study participants.

Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score \>0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=74 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=310 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline	—	—	6.8 percentage of participants	92.3 percentage of participants	—

SECONDARY outcome

Timeframe: At Week 56

Population: The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of IMP during Randomized-Withdrawal Period at Week 16 or later. The hypothesis test for PASI90 at Week 56, based on Wk16ResS, compared pooled BKZ regimens (BKZ 320mg Q4W/Q8W + 320mg Q4W/Q4W) versus placebo.

A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) n=206 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=105 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=100 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=106 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders	88.8 percentage of participants	—	16.2 percentage of participants	91.0 percentage of participants	86.8 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to end of Initial Treatment Period (up to Week 16)

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

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 adverse event (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/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	—	—	177.38 no. of new events per 100 subject-years Interval 123.55 to 246.69	323.61 no. of new events per 100 subject-years Interval 281.6 to 370.11	—

SECONDARY outcome

Timeframe: From Baseline to end of Initial Treatment Period (up to Week 16)

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

The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	—	—	7.66 no. of new events per 100 subject-years Interval 0.93 to 27.68	5.59 no. of new events per 100 subject-years Interval 2.05 to 12.17	—

SECONDARY outcome

Timeframe: From Baseline to end of Initial Treatment Period (up to Week 16)

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

The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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/Q8W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=86 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=349 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	—	—	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.	2.78 no. of new events per 100 subject-years Interval 0.57 to 8.12	—

SECONDARY outcome

Timeframe: From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

Population: The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 adverse event (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/Q8W Escape (ESS) n=106 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=1 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=105 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=100 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	208.88 no. of new events per 100 subject-years Interval 165.11 to 260.69	—	144.37 no. of new events per 100 subject-years Interval 3.66 to 804.36	242.11 no. of new events per 100 subject-years Interval 189.44 to 304.9	224.87 no. of new events per 100 subject-years Interval 177.46 to 281.05

SECONDARY outcome

Timeframe: From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

Population: The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.

The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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/Q8W Escape (ESS) n=106 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=1 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=105 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=100 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	6.64 no. of new events per 100 subject-years Interval 2.16 to 15.5	—	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.	7.20 no. of new events per 100 subject-years Interval 1.96 to 18.43	4.04 no. of new events per 100 subject-years Interval 0.83 to 11.8

SECONDARY outcome

Timeframe: From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

Population: The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.

The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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/Q8W Escape (ESS) n=106 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=1 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=105 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=100 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.	—	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.	5.33 no. of new events per 100 subject-years Interval 1.1 to 15.58	2.69 no. of new events per 100 subject-years Interval 0.33 to 9.71

SECONDARY outcome

Timeframe: From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Population: The Escape Study Participant Set (ESS) consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 adverse event (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/Q8W Escape (ESS) n=4 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) n=7 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=81 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=23 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=67 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	491.37 no. of new events per 100 subject-years Interval 101.33 to 1435.98	349.52 no. of new events per 100 subject-years Interval 95.23 to 894.91	235.86 no. of new events per 100 subject-years Interval 164.29 to 328.03	287.19 no. of new events per 100 subject-years Interval 143.36 to 513.86	180.89 no. of new events per 100 subject-years Interval 115.9 to 269.15

SECONDARY outcome

Timeframe: From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Population: The ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.

The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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/Q8W Escape (ESS) n=4 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) n=7 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=81 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=23 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=67 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.	5.24 no. of new events per 100 subject-years Interval 0.13 to 29.22	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.

SECONDARY outcome

Timeframe: From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Population: The ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.

The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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/Q8W Escape (ESS) n=4 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) n=7 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Placebo (RS) n=81 Participants Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).	Bimekizumab 320 mg Q4W (RS) n=23 Participants Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=67 Participants Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.	18.77 no. of new events per 100 subject-years Interval 0.48 to 104.58	0 no. of new events per 100 subject-years Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.

Adverse Events

Placebo (SS)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W (SS)

Serious events: 6 serious events

Other events: 66 other events

Deaths: 0 deaths

Placebo/Placebo (WK16ResS)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W/Placebo (WK16ResS)

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W/Q8W (WK16ResS)

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W/Q4W (WK16ResS)

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo Escape (ESS)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W Escape (ESS)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W/Q8W Escape (ESS)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W/Q4W Escape (ESS)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (SS) n=86 participants at risk Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).	Bimekizumab 320 mg Q4W (SS) n=349 participants at risk Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.	Placebo/Placebo (WK16ResS) n=1 participants at risk Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).	Bimekizumab 320 mg Q4W/Placebo (WK16ResS) n=105 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.	Bimekizumab 320 mg Q4W/Q8W (WK16ResS) n=100 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=106 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.	Placebo Escape (ESS) n=81 participants at risk Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).	Bimekizumab 320 mg Q4W Escape (ESS) n=23 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Bimekizumab 320 mg Q4W/ Placebo Escape (ESS) n=67 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) n=4 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) n=7 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
Cardiac disorders Myocardial infarction	1.2% 1/86 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Cardiac disorders Mitral valve prolapse	1.2% 1/86 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Eye disorders Retinal detachment	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.95% 1/105 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Gastrointestinal disorders Diverticular perforation	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Hepatobiliary disorders Cholelithiasis	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Enterovirus infection	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Pneumonia	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Cardiac disorders Acute myocardial infarction	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.0% 1/100 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Eye disorders Cataract	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Gastrointestinal disorders Diarrhoea	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	2.0% 2/100 • Number of events 2 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Otitis media chronic	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Injury, poisoning and procedural complications Injury	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.95% 1/105 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.95% 1/105 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.95% 1/105 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.2% 1/81 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Cardiac disorders Coronary artery disease	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.2% 1/81 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.2% 1/81 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.2% 1/81 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Nervous system disorders Syncope	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.2% 1/81 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).

Other adverse events

Other adverse events
Measure	Placebo (SS) n=86 participants at risk Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).	Bimekizumab 320 mg Q4W (SS) n=349 participants at risk Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.	Placebo/Placebo (WK16ResS) n=1 participants at risk Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).	Bimekizumab 320 mg Q4W/Placebo (WK16ResS) n=105 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.	Bimekizumab 320 mg Q4W/Q8W (WK16ResS) n=100 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W (WK16ResS) n=106 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.	Placebo Escape (ESS) n=81 participants at risk Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).	Bimekizumab 320 mg Q4W Escape (ESS) n=23 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Bimekizumab 320 mg Q4W/ Placebo Escape (ESS) n=67 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.	Bimekizumab 320 mg Q4W/Q8W Escape (ESS) n=4 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.	Bimekizumab 320 mg Q4W/Q4W Escape (ESS) n=7 participants at risk Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
Blood and lymphatic system disorders Neutropenia	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.57% 2/349 • Number of events 2 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.0% 1/100 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.3% 1/23 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Gastrointestinal disorders Dental caries	1.2% 1/86 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Nasopharyngitis	4.7% 4/86 • Number of events 4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	6.6% 23/349 • Number of events 27 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	19.0% 20/105 • Number of events 28 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	23.0% 23/100 • Number of events 31 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	10.4% 11/106 • Number of events 12 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.2% 1/81 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.3% 1/23 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	3.0% 2/67 • Number of events 2 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Oral candidiasis	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	6.0% 21/349 • Number of events 23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	5.7% 6/105 • Number of events 6 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	9.0% 9/100 • Number of events 18 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	11.3% 12/106 • Number of events 20 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.9% 4/81 • Number of events 5 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.3% 1/23 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	10.4% 7/67 • Number of events 8 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Upper respiratory tract infection	8.1% 7/86 • Number of events 7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.0% 14/349 • Number of events 14 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	100.0% 1/1 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.8% 5/105 • Number of events 6 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	8.0% 8/100 • Number of events 9 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	11.3% 12/106 • Number of events 17 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	3.7% 3/81 • Number of events 3 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.3% 1/23 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	3.0% 2/67 • Number of events 2 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Tinea pedis	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.1% 4/349 • Number of events 4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Impetigo	1.2% 1/86 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.57% 2/349 • Number of events 2 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.95% 1/105 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Body tinea	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	1.0% 1/100 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Infections and infestations Tinea capitis	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	25.0% 1/4 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/7 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Skin and subcutaneous tissue disorders Psoriasis	4.7% 4/86 • Number of events 5 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	2.9% 3/105 • Number of events 3 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.94% 1/106 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	4.3% 1/23 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.29% 1/349 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	2.9% 3/105 • Number of events 4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	2.8% 3/106 • Number of events 4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/86 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/349 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/105 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/100 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/106 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/81 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/23 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/67 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	0.00% 0/4 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).	14.3% 1/7 • Number of events 1 • Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration) 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 the 20-week Safety Follow-Up Period).

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60