BE ABLE 2: A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

• Sponsor: UCB Biopharma S.P.R.L. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03010527
• Collaborator: (none)
• Enrollment: 217
• Locations: 36
• Arms: 4
• Duration (Months): 21
• Patients Per Site: 6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis	Drug: Bimekizumab; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.	Other: Placebo; Subjects will receive Placebo injections every four weeks (Q4W)
Experimental: Bimekizumab dosing regimen 1 Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.	Drug: Bimekizumab; Subjects will receive bimekizumab injections every four weeks (Q4W); Other Names: UCB4940
Experimental: Bimekizumab dosing regimen 2 Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.	Drug: Bimekizumab; Subjects will receive bimekizumab injections every four weeks (Q4W); Other Names: UCB4940
Experimental: Bimekizumab dosing regimen 3 Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.	Drug: Bimekizumab; Subjects will receive bimekizumab injections every four weeks (Q4W); Other Names: UCB4940

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment [From Baseline until Safety Follow-Up Visit (up to Week 64)]

   Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.

Secondary Outcome Measures

1. Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time [From Baseline during the Treatment Period (up to Week 48)]

   The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.

2. Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time [From Baseline during the Treatment Period (up to Week 48)]

   The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subject has provided informed consent

• Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria

• Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

Exclusion Criteria:

• Subject has previously participated in this study.

• Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose

• Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.

• Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ps0011 708	Los Angeles	California	United States	90045
2	Ps0011 706	Washington	District of Columbia	United States	20037
3	Ps0011 704	West Des Moines	Iowa	United States	50265
4	Ps0011 738	Wilmington	North Carolina	United States	28405
5	Ps0011 712	Portland	Oregon	United States	97223
6	Ps0011 733	Dallas	Texas	United States	75231
7	Ps0011 709	Houston	Texas	United States	77004
8	Ps0011 702	Houston	Texas	United States	77598
9	Ps0011 209	Edmonton		Canada
10	Ps0011 201	North Bay		Canada
11	Ps0011 206	Peterborough		Canada
12	Ps0011 214	Quebec City		Canada
13	Ps0011 203	Surrey		Canada
14	Ps0011 205	Waterloo		Canada
15	Ps0011 300	Ostrava		Czechia
16	Ps0011 303	Pardubice		Czechia
17	Ps0011 301	Praha 10		Czechia
18	Ps0011 304	Praha		Czechia
19	Ps0011 404	Kecskemet		Hungary
20	Ps0011 400	Oroshaza		Hungary
21	Ps0011 405	Szekszard		Hungary
22	Ps0011 504	Chiyoda-ku		Japan
23	Ps0011 503	Minatoku		Japan
24	Ps0011 502	Nagoya		Japan
25	Ps0011 501	Shinagawa-ku		Japan
26	Ps0011 600	Bialystok		Poland
27	Ps0011 603	Bialystok		Poland
28	Ps0011 611	Bialystok		Poland
29	Ps0011 610	Gdynia		Poland
30	Ps0011 604	Kielce		Poland
31	Ps0011 608	Krakow		Poland
32	Ps0011 605	Lublin		Poland
33	Ps0011 606	Lublin		Poland
34	Ps0011 607	Warszawa		Poland
35	Ps0011 601	Wroclaw		Poland
36	Ps0011 609	Wroclaw		Poland

Sponsors and Collaborators

• UCB Biopharma S.P.R.L.

Investigators

• Study Director: UCB Cares, [phone](UCB)

Study Documents (Full-Text)

• Study Protocol - Aug 12, 2016
• Statistical Analysis Plan - Jun 7, 2018

More Information

Additional Information:

• Product Information

Publications

None provided.

• Responsible Party: UCB Biopharma S.P.R.L.
• ClinicalTrials.gov Identifier: NCT03010527
• Other Study ID Numbers: PS0011; 2016-001892-57
• First Posted: Jan 5, 2017
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by UCB Biopharma S.P.R.L.: Chronic plaque psoriasis; Psoriasis; Bimekizumab
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	The study started to enroll participants in December 2016 and concluded in September 2018. Among the 217 participants in PS0011, no participants were assigned to receive placebo.
Pre-assignment Detail	Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W	Bimekizumab 160 mg Q4W	Bimekizumab 320 mg Q4W
Arm/Group Description	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.	Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
Period Title: Overall Study
STARTED	15	111	91
COMPLETED	15	92	75
NOT COMPLETED	0	19	16

Baseline Characteristics

Arm/Group Title	Bimekizumab 64 mg Q4W	Bimekizumab 160 mg Q4W	Bimekizumab 320 mg Q4W	Total Title
Arm/Group Description	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.	Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
Overall Participants	15	111	91	217
Age (Count of Participants)
<=18 years	0 0%	1 0.9%	2 2.2%	3 1.4%
Between 18 and 65 years	14 93.3%	105 94.6%	77 84.6%	196 90.3%
>=65 years	1 6.7%	5 4.5%	12 13.2%	18 8.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.5 (14.7)	44.5 (12.8)	43.5 (14.7)	44.1 (13.7)
Sex: Female, Male (Count of Participants)
Female	6 40%	40 36%	31 34.1%	77 35.5%
Male	9 60%	71 64%	60 65.9%	140 64.5%
Race/Ethnicity, Customized (Count of Participants)
American Indian /Alaskan native	0 0%	1 0.9%	1 1.1%	2 0.9%
Asian	1 6.7%	11 9.9%	6 6.6%	18 8.3%
Black	1 6.7%	0 0%	1 1.1%	2 0.9%
White	13 86.7%	99 89.2%	83 91.2%	195 89.9%

Outcome Measures

1. Primary Outcome

Title	Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Description	Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
Time Frame	From Baseline until Safety Follow-Up Visit (up to Week 64)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W (SS)	Bimekizumab 160 mg Q4W (SS)	Bimekizumab 320 mg Q4W (SS)
Arm/Group Description	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
Measure Participants	15	111	91
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	110.68	225.26	206.82

2. Secondary Outcome

Title	Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
Description	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Time Frame	From Baseline during the Treatment Period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for Psoriasis Area and Severity Index (PASI) at Baseline of PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Placebo/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)
Arm/Group Description	Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).	Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Measure Participants	15	55	33	30	37	19	14	6	8
PS0011 Baseline	100 666.7%	100 90.1%	100 109.9%	100 46.1%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Week 4	100 666.7%	100 90.1%	97.0 106.6%	100 46.1%	45.9 NaN	42.1 NaN	42.9 NaN	66.7 NaN	50.0 NaN
Week 8	100 666.7%	96.4 86.8%	100 109.9%	100 46.1%	67.6 NaN	73.7 NaN	57.1 NaN	83.3 NaN	50.0 NaN
Week 12	100 666.7%	96.4 86.8%	100 109.9%	96.7 44.6%	81.1 NaN	78.9 NaN	64.3 NaN	100 NaN	62.5 NaN
Week 16	100 666.7%	92.7 83.5%	100 109.9%	96.7 44.6%	83.8 NaN	78.9 NaN	64.3 NaN	100 NaN	62.5 NaN
Week 20	100 666.7%	89.1 80.3%	93.9 103.2%	96.7 44.6%	89.2 NaN	84.2 NaN	78.6 NaN	83.3 NaN	62.5 NaN
Week 24	100 666.7%	85.5 77%	97.0 106.6%	96.7 44.6%	83.8 NaN	78.9 NaN	71.4 NaN	83.3 NaN	75.0 NaN
Week 28	93.3 622%	90.9 81.9%	97.0 106.6%	96.7 44.6%	91.9 NaN	84.2 NaN	71.4 NaN	83.3 NaN	50.0 NaN
Week 32	100 666.7%	89.1 80.3%	97.0 106.6%	93.3 43%	91.9 NaN	73.7 NaN	71.4 NaN	83.3 NaN	50.0 NaN
Week 36	100 666.7%	85.5 77%	97.0 106.6%	93.3 43%	91.9 NaN	73.7 NaN	71.4 NaN	66.7 NaN	50.0 NaN
Week 40	100 666.7%	83.6 75.3%	87.9 96.6%	86.7 40%	89.2 NaN	78.9 NaN	71.4 NaN	83.3 NaN	50.0 NaN
Week 44	100 666.7%	81.8 73.7%	87.9 96.6%	86.7 40%	89.2 NaN	78.9 NaN	71.4 NaN	83.3 NaN	50.0 NaN
Week 48	100 666.7%	80.0 72.1%	87.9 96.6%	86.7 40%	91.9 NaN	68.4 NaN	71.4 NaN	66.7 NaN	50.0 NaN

3. Secondary Outcome

Title	Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
Description	The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Time Frame	From Baseline during the Treatment Period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for PASI at Baseline of PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Placebo/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)
Arm/Group Description	Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).	Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Measure Participants	15	55	33	30	37	19	14	6	8
PS0011 Baseline	100 666.7%	96.4 86.8%	100 109.9%	100 46.1%	5.4 NaN	10.5 NaN	35.7 NaN	50.0 NaN	25.0 NaN
Week 4	100 666.7%	98.2 88.5%	97.0 106.6%	100 46.1%	56.8 NaN	57.9 NaN	42.9 NaN	66.7 NaN	62.5 NaN
Week 8	100 666.7%	96.4 86.8%	97.0 106.6%	100 46.1%	75.7 NaN	84.2 NaN	57.1 NaN	83.3 NaN	62.5 NaN
Week 12	100 666.7%	92.7 83.5%	97.0 106.6%	96.7 44.6%	81.1 NaN	89.5 NaN	64.3 NaN	83.3 NaN	62.5 NaN
Week 16	100 666.7%	90.9 81.9%	97.0 106.6%	96.7 44.6%	83.8 NaN	78.9 NaN	57.1 NaN	66.7 NaN	62.5 NaN
Week 20	100 666.7%	85.5 77%	93.9 103.2%	96.7 44.6%	89.2 NaN	84.2 NaN	71.4 NaN	66.7 NaN	75.0 NaN
Week 24	100 666.7%	81.8 73.7%	97.0 106.6%	93.3 43%	83.8 NaN	84.2 NaN	64.3 NaN	83.3 NaN	62.5 NaN
Week 28	93.3 622%	89.1 80.3%	97.0 106.6%	93.3 43%	86.5 NaN	84.2 NaN	71.4 NaN	66.7 NaN	62.5 NaN
Week 32	100 666.7%	85.5 77%	93.9 103.2%	93.3 43%	89.2 NaN	78.9 NaN	71.4 NaN	66.7 NaN	50.0 NaN
Week 36	100 666.7%	81.8 73.7%	90.9 99.9%	93.3 43%	86.5 NaN	78.9 NaN	71.4 NaN	66.7 NaN	37.5 NaN
Week 40	100 666.7%	83.6 75.3%	87.9 96.6%	86.7 40%	86.5 NaN	78.9 NaN	71.4 NaN	66.7 NaN	50.0 NaN
Week 44	100 666.7%	81.8 73.7%	87.9 96.6%	86.7 40%	83.8 NaN	78.9 NaN	71.4 NaN	66.7 NaN	50.0 NaN
Week 48	100 666.7%	78.2 70.5%	87.9 96.6%	86.7 40%	89.2 NaN	68.4 NaN	71.4 NaN	66.7 NaN	62.5 NaN

Adverse Events

Time Frame	From PS0011 Baseline and up to Safety-Follow Up (SFU)
Arm/Group Title	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
Arm/Group Description	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).		Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.		Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
All Cause Mortality
	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/111 (0%)		2/91 (2.2%)
Serious Adverse Events
	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		7/111 (6.3%)		7/91 (7.7%)
Cardiac disorders
Cardiac failure	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Eye disorders
Cataract	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
General disorders
Non-cardiac chest pain	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Infections and infestations
Otitis externa bacterial	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Staphylococcal abscess	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Injury, poisoning and procedural complications
Humerus fracture	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Tibia fracture	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Investigations
Hepatic enzyme increased	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Nervous system disorders
Carpal tunnel syndrome	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	2
Renal and urinary disorders
IgA nephropathy	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Nephrolithiasis	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Ureterolithiasis	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Renal colic	0/15 (0%)	0	1/111 (0.9%)	2	0/91 (0%)	0
Reproductive system and breast disorders
Uterine cervix stenosis	0/15 (0%)	0	1/111 (0.9%)	1	0/91 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	2
Respiratory failure	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Surgical and medical procedures
Abortion induced	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Vascular disorders
Circulatory collapse	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Hypovolaemic shock	0/15 (0%)	0	0/111 (0%)	0	1/91 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/15 (66.7%)		56/111 (50.5%)		51/91 (56%)
Ear and labyrinth disorders
External ear inflammation	1/15 (6.7%)	1	0/111 (0%)	0	1/91 (1.1%)	1
Gastrointestinal disorders
Diarrhoea	1/15 (6.7%)	1	0/111 (0%)	0	1/91 (1.1%)	1
Flatulence	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Hepatobiliary disorders
Non-alcoholic fatty liver	1/15 (6.7%)	1	1/111 (0.9%)	1	0/91 (0%)	0
Infections and infestations
Oral candidiasis	1/15 (6.7%)	2	13/111 (11.7%)	17	15/91 (16.5%)	19
Skin candida	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Angular cheilitis	1/15 (6.7%)	1	2/111 (1.8%)	3	0/91 (0%)	0
Gingivitis	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Vulvovaginal mycotic infection	1/15 (6.7%)	2	1/111 (0.9%)	1	0/91 (0%)	0
Nasopharyngitis	2/15 (13.3%)	4	15/111 (13.5%)	20	11/91 (12.1%)	14
Upper respiratory tract infection	1/15 (6.7%)	1	10/111 (9%)	12	9/91 (9.9%)	12
Pharyngitis	1/15 (6.7%)	1	1/111 (0.9%)	1	3/91 (3.3%)	3
Urinary tract infection	2/15 (13.3%)	3	1/111 (0.9%)	1	1/91 (1.1%)	2
Respiratory tract infection viral	1/15 (6.7%)	1	1/111 (0.9%)	1	1/91 (1.1%)	1
Injury, poisoning and procedural complications
Joint injury	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Procedural pain	1/15 (6.7%)	2	0/111 (0%)	0	0/91 (0%)	0
Investigations
Gamma-glutamyl-transferase increased	1/15 (6.7%)	1	4/111 (3.6%)	6	3/91 (3.3%)	4
Metabolism and nutrition disorders
Hyperphagia	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/15 (0%)	0	3/111 (2.7%)	4	6/91 (6.6%)	7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour	1/15 (6.7%)	1	0/111 (0%)	0	0/91 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/15 (0%)	0	6/111 (5.4%)	6	6/91 (6.6%)	8
Skin and subcutaneous tissue disorders
Dermatitis contact	1/15 (6.7%)	1	5/111 (4.5%)	6	3/91 (3.3%)	3
Seborrhoeic dermatitis	1/15 (6.7%)	1	3/111 (2.7%)	4	2/91 (2.2%)	2
Pruritus generalised	1/15 (6.7%)	1	0/111 (0%)	0	1/91 (1.1%)	1
Psoriasis	2/15 (13.3%)	2	5/111 (4.5%)	6	5/91 (5.5%)	5
Vascular disorders
Hypertension	2/15 (13.3%)	2	8/111 (7.2%)	10	4/91 (4.4%)	4

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.