BE READY: 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

• Sponsor: UCB Biopharma SRL (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03410992
• Collaborator: (none)
• Enrollment: 435
• Locations: 77
• Arms: 3
• Actual Duration (Months): 23
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis	Drug: Bimekizumab; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 435 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an 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
• Actual Study Start Date: Feb 5, 2018
• Actual Primary Completion Date: Dec 28, 2018
• Actual Study Completion Date: Jan 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimekizumab cohort Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.	Drug: Bimekizumab; Bimekizumab will be provided at pre-specified time intervals.; Other Names: UCB4940 ; Other: Placebo; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.; Other Names: PBO
Placebo Comparator: Placebo Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.	Other: Placebo; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.; Other Names: PBO
Experimental: Bimekizumab Escape arm Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.	Drug: Bimekizumab; Bimekizumab will be provided at pre-specified time intervals.; Other Names: UCB4940

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [At Week 16]

   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).

2. Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 [At Week 16]

   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).

Secondary Outcome Measures

1. Percentage of Participants With a PASI100 Response at Week 16 [At Week 16]

   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).

2. Percentage of Participants With a IGA Clear Response at Week 16 [At Week 16]

   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).

3. Percentage of Participants With a PASI75 Response at Week 4 [At Week 4]

   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.

4. Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16 [At Week 16]

   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.

5. Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16 [At Week 16]

   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.

6. Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16 [At Week 16]

   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.

7. Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline [At Week 16]

   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.

8. Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders [At Week 56]

   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).

9. Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period (up to Week 16)]

   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.

10. Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period (up to Week 16)]

    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.

11. Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period (up to Week 16)]

    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.

12. Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period [From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)]

    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.

13. Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period [From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)]

    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.

14. Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period [From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)]

    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.

15. Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment [From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)]

    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.

16. Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment [From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)]

    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.

17. Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment [From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be at least 18 years of age

• Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

• Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO

=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

• Subject is a candidate for systemic PSO therapy and/or phototherapy

• Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

• Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections

• Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection

• Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

• Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study

• Presence of active suicidal ideation or positive suicide behavior

• Presence of moderately severe major depression or severe major depression

• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ps0013 919	San Diego	California	United States	92103
2	Ps0013 955	San Diego	California	United States	92123
3	Ps0013 967	Santa Monica	California	United States	90404
4	Ps0013 928	Fort Myers	Florida	United States	33912
5	Ps0013 966	Sandy Springs	Georgia	United States	30329
6	Ps0013 954	Skokie	Illinois	United States	60077
7	Ps0013 962	Owensboro	Kentucky	United States	42303
8	Ps0013 944	New Orleans	Louisiana	United States	70115
9	Ps0013 940	Beverly	Massachusetts	United States	01915
10	Ps0013 901	Portsmouth	New Hampshire	United States	03801
11	Ps0013 956	Verona	New Jersey	United States	07044-2946
12	Ps0013 947	Buffalo	New York	United States	14221
13	Ps0013 968	New York	New York	United States	10021
14	Ps0013 965	New York	New York	United States	10025
15	Ps0013 963	Rochester	New York	United States	14623
16	Ps0013 949	Cleveland	Ohio	United States	44106-1716
17	Ps0013 929	Portland	Oregon	United States	97223
18	Ps0013 937	Johnston	Rhode Island	United States	02919
19	Ps0013 914	San Antonio	Texas	United States	78213
20	Ps0013 933	Murray	Utah	United States	84107
21	Ps0013 003	Carlton		Australia
22	Ps0013 008	East Melbourne		Australia
23	Ps0013 006	Kogarah		Australia
24	Ps0013 658	Ajax		Canada
25	Ps0013 672	Edmonton		Canada
26	Ps0013 671	Hamilton		Canada
27	Ps0013 675	Markham		Canada
28	Ps0013 663	Mississauga		Canada
29	Ps0013 660	Montréal		Canada
30	Ps0013 668	North Bay		Canada
31	Ps0013 667	Ottawa		Canada
32	Ps0013 665	Québec		Canada
33	Ps0013 676	Surrey		Canada
34	Ps0013 657	Waterloo		Canada
35	Ps0013 202	Hamburg		Germany
36	Ps0013 220	Hamburg		Germany
37	Ps0013 219	Münster		Germany
38	Ps0013 200	Schwerin		Germany
39	Ps0013 204	Witten		Germany
40	Ps0013 261	Budapest		Hungary
41	Ps0013 262	Miskolc		Hungary
42	Ps0013 253	Orosháza		Hungary
43	Ps0013 260	Szeged		Hungary
44	Ps0013 250	Szolnok		Hungary
45	Ps0013 258	Veszprém		Hungary
46	Ps0013 701	Busan		Korea, Republic of
47	Ps0013 705	Seongnam-si		Korea, Republic of
48	Ps0013 703	Seoul		Korea, Republic of
49	Ps0013 355	Białystok		Poland
50	Ps0013 361	Białystok		Poland
51	Ps0013 369	Białystok		Poland
52	Ps0013 352	Gdańsk		Poland
53	Ps0013 358	Katowice		Poland
54	Ps0013 359	Katowice		Poland
55	Ps0013 366	Katowice		Poland
56	Ps0013 357	Kielce		Poland
57	Ps0013 363	Kraków		Poland
58	Ps0013 356	Lublin		Poland
59	Ps0013 374	Poznań		Poland
60	Ps0013 353	Szczecin		Poland
61	Ps0013 350	Warsaw		Poland
62	Ps0013 351	Warsaw		Poland
63	Ps0013 354	Warszawa		Poland
64	Ps0013 365	Wrocław		Poland
65	Ps0013 368	Wrocław		Poland
66	Ps0013 370	Wrocław		Poland
67	Ps0013 360	Łódź		Poland
68	Ps0013 400	Moscow		Russian Federation
69	Ps0013 402	Moscow		Russian Federation
70	Ps0013 403	Moscow		Russian Federation
71	Ps0013 404	Saint Petersburg		Russian Federation
72	Ps0013 405	Saint Petersburg		Russian Federation
73	Ps0013 401	Saratov		Russian Federation
74	Ps0013 406	Yaroslavl		Russian Federation
75	Ps0013 550	Manchester		United Kingdom
76	Ps0013 554	Reading		United Kingdom
77	Ps0013 555	Salford		United Kingdom

Sponsors and Collaborators

• UCB Biopharma SRL

Investigators

• Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study Documents (Full-Text)

• Study Protocol - May 21, 2019
• Statistical Analysis Plan - Sep 16, 2019

More Information

Additional Information:

• Product Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT03410992
• Other Study ID Numbers: PS0013; 2016-003426-16
• First Posted: Jan 25, 2018
• Last Update Posted: Jul 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by UCB Biopharma SRL: Bimekizumab; PSO; Psoriasis
• Additional relevant MeSH terms: Arthritis, Psoriatic; Psoriasis

Study Results

Participant Flow

Recruitment Details	The study started to enroll patients in February 2018 and concluded in January 2020.
Pre-assignment Detail	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.

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W	Placebo/Placebo	Bimekizumab 320 mg Q4W/Placebo	Bimekizumab 320 mg Q4W/Q8W	Bimekizumab 320 mg Q4W/Q4W	Placebo Escape	Bimekizumab 320 mg Q4W Escape	Bimekizumab 320 mg Q4W/ Placebo Escape	Bimekizumab 320 mg Q4W/Q8W Escape	Bimekizumab 320 mg Q4W/Q4W Escape
Arm/Group Description	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 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 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 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 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.	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 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 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 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 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.	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.
Period Title: Initial Treatment Period: up to Wk16
STARTED	86	349	0	0	0	0	0	0	0	0	0
COMPLETED	82	340	0	0	0	0	0	0	0	0	0
NOT COMPLETED	4	9	0	0	0	0	0	0	0	0	0
Period Title: Initial Treatment Period: up to Wk16
STARTED	82	340	0	0	0	0	0	0	0	0	0
Received Escape Treatment	81	23	0	0	0	0	0	0	0	0	0
COMPLETED	1	311	0	0	0	0	0	0	0	0	0
NOT COMPLETED	81	29	0	0	0	0	0	0	0	0	0
Period Title: Initial Treatment Period: up to Wk16
STARTED	0	0	1	105	100	106	0	0	0	0	0
Received Escape Treatment	0	0	0	67	4	7	0	0	0	0	0
COMPLETED	0	0	1	33	93	94	0	0	0	0	0
NOT COMPLETED	0	0	0	72	7	12	0	0	0	0	0
Period Title: Initial Treatment Period: up to Wk16
STARTED	0	0	0	0	0	0	81	23	67	4	7
COMPLETED	0	0	0	0	0	0	81	22	66	4	7
NOT COMPLETED	0	0	0	0	0	0	0	1	1	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Bimekizumab 320 mg Q4W	Total Title
Arm/Group Description	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 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.
Overall Participants	86	349	435
Age (Count of Participants)
<=18 years	2 2.3%	1 0.3%	3 0.7%
Between 18 and 65 years	80 93%	327 93.7%	407 93.6%
>=65 years	4 4.7%	21 6%	25 5.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (13.1)	44.5 (12.9)	44.3 (12.9)
Sex: Female, Male (Count of Participants)
Female	28 32.6%	94 26.9%	122 28%
Male	58 67.4%	255 73.1%	313 72%
Race/Ethnicity, Customized (Count of Participants)
Asian	5 5.8%	13 3.7%	18 4.1%
Black	0 0%	6 1.7%	6 1.4%
Native Hawaiian or other Pacific Islander	0 0%	2 0.6%	2 0.5%
White	79 91.9%	324 92.8%	403 92.6%
Other/mixed	2 2.3%	4 1.1%	6 1.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Description	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).
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number [percentage of participants]	1.2 1.4%	90.8 26%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	496.318
	Confidence Interval	(2-Sided) 95%; 82.798 to 2975.086
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16
Description	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).
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number [percentage of participants]	1.2 1.4%	92.6 26.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	657.255
	Confidence Interval	(2-Sided) 95%; 105.792 to 4083.333
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants With a PASI100 Response at Week 16
Description	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).
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number [percentage of participants]	1.2 1.4%	68.2 19.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	220.038
	Confidence Interval	(2-Sided) 95%; 28.757 to 1683.639
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants With a IGA Clear Response at Week 16
Description	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).
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number [percentage of participants]	1.2 1.4%	69.6 19.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	224.744
	Confidence Interval	(2-Sided) 95%; 30.130 to 1676.425
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants With a PASI75 Response at Week 4
Description	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.
Time Frame	At Week 4

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number [percentage of participants]	1.2 1.4%	75.9 21.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	316.641
	Confidence Interval	(2-Sided) 95%; 39.423 to 2543.254
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
Description	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.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	67	255
Number [percentage of participants]	9.0 10.5%	78.8 22.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	34.325
	Confidence Interval	(2-Sided) 95%; 14.220 to 82.856
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
Description	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.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	72	278
Number [percentage of participants]	5.6 6.5%	75.5 21.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	43.497
	Confidence Interval	(2-Sided) 95%; 15.728 to 120.295
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
Description	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.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	70	286
Number [percentage of participants]	5.7 6.6%	78.0 22.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	60.946
	Confidence Interval	(2-Sided) 95%; 20.560 to 180.669
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline
Description	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.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (RS)	Bimekizumab 320 mg Q4W (RS)
Arm/Group Description	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).	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.
Measure Participants	74	310
Number [percentage of participants]	6.8 7.9%	92.3 26.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	158.000
	Confidence Interval	(2-Sided) 95%; 49.263 to 506.745
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders
Description	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).
Time Frame	At Week 56

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab 320 mg Q4W/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Q8W (WK16ResS)	Bimekizumab 320 mg Q4W/Q4W (WK16ResS)	Bimekizumab 320 mg Q4W/Q8W+Q4W/Q4W (WK16ResS)
Arm/Group Description	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.	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.	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.	This arm consists of participants who 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 and those who 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.
Measure Participants	105	100	106	206
Number [percentage of participants]	16.2 18.8%	91.0 26.1%	86.8 20%	88.8 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W (RS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	45.192
	Confidence Interval	(2-Sided) 95%; 18.622 to 109.672
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	49.297
	Confidence Interval	(2-Sided) 95%; 18.887 to 128.673
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo (RS), Bimekizumab 320 mg Q4W/Q8W+Q4W/Q4W (WK16ResS)
	Comments	Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values for the comparison of treatment groups were based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	47.406
	Confidence Interval	(2-Sided) 95%; 22.087 to 101.750
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
Description	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.
Time Frame	From Baseline to end of Initial Treatment Period (up to Week 16)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Bimekizumab 320 mg Q4W (SS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	177.38	323.61

12. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
Description	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.
Time Frame	From Baseline to end of Initial Treatment Period (up to Week 16)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Bimekizumab 320 mg Q4W (SS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	7.66	5.59

13. Secondary Outcome

Title	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
Description	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.
Time Frame	From Baseline to end of Initial Treatment Period (up to Week 16)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Bimekizumab 320 mg Q4W (SS)
Arm/Group Description	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).	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.
Measure Participants	86	349
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	0	2.78

14. Secondary Outcome

Title	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
Description	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.
Time Frame	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Q8W (WK16ResS)	Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Arm/Group Description	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).	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.	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.	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.
Measure Participants	1	105	100	106
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	144.37	242.11	224.87	208.88

15. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
Description	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.
Time Frame	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Q8W (WK16ResS)	Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Arm/Group Description	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).	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.	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.	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.
Measure Participants	1	105	100	106
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	0	7.20	4.04	6.64

16. Secondary Outcome

Title	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
Description	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.
Time Frame	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Placebo (WK16ResS)	Bimekizumab 320 mg Q4W/Q8W (WK16ResS)	Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Arm/Group Description	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).	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.	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.	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.
Measure Participants	1	105	100	106
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	0	5.33	2.69	0

17. Secondary Outcome

Title	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
Description	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.
Time Frame	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Escape (ESS)	Bimekizumab 320 mg Q4W Escape (ESS)	Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)	Bimekizumab 320 mg Q4W/Q8W Escape (ESS)	Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Arm/Group Description	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).	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.	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.	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.	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.
Measure Participants	81	23	67	4	7
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	235.86	287.19	180.89	491.37	349.52

18. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
Description	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.
Time Frame	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Escape (ESS)	Bimekizumab 320 mg Q4W Escape (ESS)	Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)	Bimekizumab 320 mg Q4W/Q8W Escape (ESS)	Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Arm/Group Description	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).	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.	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.	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.	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.
Measure Participants	81	23	67	4	7
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	5.24	0	0	0	0

19. Secondary Outcome

Title	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
Description	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.
Time Frame	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Escape (ESS)	Bimekizumab 320 mg Q4W Escape (ESS)	Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)	Bimekizumab 320 mg Q4W/Q8W Escape (ESS)	Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Arm/Group Description	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).	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.	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.	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.	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.
Measure Participants	81	23	67	4	7
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	0	18.77	0	0	0

Adverse Events

Time Frame	Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)
Adverse Event Reporting Description	Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up Period).
Arm/Group Title	Placebo (SS)		Bimekizumab 320 mg Q4W (SS)		Placebo/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Q8W (WK16ResS)		Bimekizumab 320 mg Q4W/Q4W (WK16ResS)		Placebo Escape (ESS)		Bimekizumab 320 mg Q4W Escape (ESS)		Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)		Bimekizumab 320 mg Q4W/Q8W Escape (ESS)		Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Arm/Group Description	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).		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.		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).		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.		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.		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.		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).		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.		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.		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.		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.
All Cause Mortality
	Placebo (SS)		Bimekizumab 320 mg Q4W (SS)		Placebo/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Q8W (WK16ResS)		Bimekizumab 320 mg Q4W/Q4W (WK16ResS)		Placebo Escape (ESS)		Bimekizumab 320 mg Q4W Escape (ESS)		Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)		Bimekizumab 320 mg Q4W/Q8W Escape (ESS)		Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/349 (0%)		0/1 (0%)		0/105 (0%)		0/100 (0%)		0/106 (0%)		0/81 (0%)		0/23 (0%)		0/67 (0%)		0/4 (0%)		0/7 (0%)
Serious Adverse Events
	Placebo (SS)		Bimekizumab 320 mg Q4W (SS)		Placebo/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Q8W (WK16ResS)		Bimekizumab 320 mg Q4W/Q4W (WK16ResS)		Placebo Escape (ESS)		Bimekizumab 320 mg Q4W Escape (ESS)		Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)		Bimekizumab 320 mg Q4W/Q8W Escape (ESS)		Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/86 (2.3%)		6/349 (1.7%)		0/1 (0%)		4/105 (3.8%)		3/100 (3%)		5/106 (4.7%)		1/81 (1.2%)		0/23 (0%)		0/67 (0%)		0/4 (0%)		0/7 (0%)
Cardiac disorders
Myocardial infarction	1/86 (1.2%)	1	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Mitral valve prolapse	1/86 (1.2%)	1	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Acute myocardial infarction	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	1/100 (1%)	1	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Ischaemic cardiomyopathy	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	1/81 (1.2%)	1	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Coronary artery disease	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	1/81 (1.2%)	1	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Eye disorders
Retinal detachment	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	1/105 (1%)	1	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Cataract	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Gastrointestinal disorders
Gastrointestinal inflammation	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Diverticular perforation	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Diarrhoea	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	2/100 (2%)	2	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Duodenal ulcer haemorrhage	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	1/81 (1.2%)	1	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Infections and infestations
Enterovirus infection	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Pneumonia	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Otitis media chronic	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Injury, poisoning and procedural complications
Humerus fracture	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Injury	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Metabolism and nutrition disorders
Type 2 diabetes mellitus	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	1/81 (1.2%)	1	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Prostate cancer	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	1/105 (1%)	1	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Nervous system disorders
Syncope	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	1/81 (1.2%)	1	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	1/105 (1%)	1	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	1/105 (1%)	1	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo (SS)		Bimekizumab 320 mg Q4W (SS)		Placebo/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Placebo (WK16ResS)		Bimekizumab 320 mg Q4W/Q8W (WK16ResS)		Bimekizumab 320 mg Q4W/Q4W (WK16ResS)		Placebo Escape (ESS)		Bimekizumab 320 mg Q4W Escape (ESS)		Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)		Bimekizumab 320 mg Q4W/Q8W Escape (ESS)		Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/86 (17.4%)		66/349 (18.9%)		1/1 (100%)		34/105 (32.4%)		40/100 (40%)		34/106 (32.1%)		8/81 (9.9%)		5/23 (21.7%)		11/67 (16.4%)		3/4 (75%)		4/7 (57.1%)
Blood and lymphatic system disorders
Neutropenia	0/86 (0%)	0	2/349 (0.6%)	2	0/1 (0%)	0	0/105 (0%)	0	1/100 (1%)	1	0/106 (0%)	0	0/81 (0%)	0	1/23 (4.3%)	1	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1
Gastrointestinal disorders
Dental caries	1/86 (1.2%)	1	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	1/4 (25%)	1	0/7 (0%)	0
Infections and infestations
Nasopharyngitis	4/86 (4.7%)	4	23/349 (6.6%)	27	0/1 (0%)	0	20/105 (19%)	28	23/100 (23%)	31	11/106 (10.4%)	12	1/81 (1.2%)	1	1/23 (4.3%)	1	2/67 (3%)	2	0/4 (0%)	0	0/7 (0%)	0
Oral candidiasis	0/86 (0%)	0	21/349 (6%)	23	0/1 (0%)	0	6/105 (5.7%)	6	9/100 (9%)	18	12/106 (11.3%)	20	4/81 (4.9%)	5	1/23 (4.3%)	1	7/67 (10.4%)	8	0/4 (0%)	0	0/7 (0%)	0
Upper respiratory tract infection	7/86 (8.1%)	7	14/349 (4%)	14	1/1 (100%)	1	5/105 (4.8%)	6	8/100 (8%)	9	12/106 (11.3%)	17	3/81 (3.7%)	3	1/23 (4.3%)	1	2/67 (3%)	2	0/4 (0%)	0	1/7 (14.3%)	1
Tinea pedis	0/86 (0%)	0	4/349 (1.1%)	4	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1
Impetigo	1/86 (1.2%)	1	2/349 (0.6%)	2	0/1 (0%)	0	1/105 (1%)	1	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	1/4 (25%)	1	0/7 (0%)	0
Body tinea	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	0/105 (0%)	0	1/100 (1%)	1	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1
Tinea capitis	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1
Injury, poisoning and procedural complications
Rib fracture	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	1/4 (25%)	1	0/7 (0%)	0
Skin and subcutaneous tissue disorders
Psoriasis	4/86 (4.7%)	5	1/349 (0.3%)	1	0/1 (0%)	0	3/105 (2.9%)	3	0/100 (0%)	0	1/106 (0.9%)	1	0/81 (0%)	0	1/23 (4.3%)	1	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1
Seborrhoeic dermatitis	0/86 (0%)	0	1/349 (0.3%)	1	0/1 (0%)	0	3/105 (2.9%)	4	0/100 (0%)	0	3/106 (2.8%)	4	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1
Rash papular	0/86 (0%)	0	0/349 (0%)	0	0/1 (0%)	0	0/105 (0%)	0	0/100 (0%)	0	0/106 (0%)	0	0/81 (0%)	0	0/23 (0%)	0	0/67 (0%)	0	0/4 (0%)	0	1/7 (14.3%)	1

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.