A Study With a Initial Treatment Period Followed by a Ran... | NCT03410992 | Trialant
NCT03410992
Sponsor
UCB Biopharma SRL
Status
Completed
Last Update Posted
Apr 15, 2026Actual
Enrollment
435Actual
Phase
Phase 3
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Psoriatic Arthritis
Interventions
Bimekizumab
Placebo
Countries
United States
Australia
Canada
Germany
Hungary
Poland
Russia
South Korea
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03410992
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PS0013
Secondary IDs
ID
Type
Description
Link
2016-003426-16
EudraCT Number
Brief Title
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
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
Acronym
BE READY
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 5, 2018Actual
Primary Completion Date
Dec 28, 2018Actual
Completion Date
Jan 7, 2020Actual
First Submitted Date
Jan 19, 2018
First Submission Date that Met QC Criteria
Jan 19, 2018
First Posted Date
Jan 25, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 20, 2021
Results First Submitted that Met QC Criteria
Feb 9, 2022
Results First Posted Date
Mar 4, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 6, 2020
Certification/Extension First Submitted that Passed QC Review
Feb 9, 2022
Certification/Extension First Posted Date
Mar 4, 2022Actual
Last Update Submitted Date
Apr 2, 2026
Last Update Posted Date
Apr 15, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB Biopharma SRLINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Psoriatic Arthritis
Keywords
Bimekizumab
PSO
Psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
435Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Bimekizumab cohort
Experimental
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
Other: Placebo
Placebo
Placebo Comparator
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
Bimekizumab Escape arm
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bimekizumab
Drug
Bimekizumab will be provided at pre-specified time intervals.
Bimekizumab Escape arm
Bimekizumab cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response 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).
At Week 16
Percentage of Participants With an Investigator's Global Assessment (IGA) Response 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).
At Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a PASI100 Response 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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
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.
Recruitment Details
The study started to enroll patients in February 2018 and concluded in January 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Bimekizumab cohort
Placebo
PBO
At Week 16
Percentage of Participants With a IGA Clear Response 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).
At Week 16
Percentage of Participants With a PASI75 Response 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.
At Week 4
Percentage of Participants With a Patient Symptom Diary Response for Pain 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.
At Week 16
Percentage of Participants With a Patient Symptom Diary Response for Itch 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.
At Week 16
Percentage of Participants With a Patient Symptom Diary Response for Scaling 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.
At Week 16
Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline
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.
At Week 16
Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders
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).
At Week 56
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
From Baseline to end of Initial Treatment Period (up to Week 16)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline to end of Initial Treatment Period (up to Week 16)
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline to end of Initial Treatment Period (up to Week 16)
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
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.
From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
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.
From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
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.
From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429.
Armstrong A, Papp KA, Lebwohl M, Savage LJ, Yamanaka K, Vlase DE, Warham R, Lambert J, Lopez Pinto JM, Wixted K, Thaci D. Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. Dermatol Ther (Heidelb). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8.
Krueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Apr;157(4):905-916. doi: 10.1016/j.jaci.2025.12.1013. Epub 2026 Jan 22.
Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9.
Blauvelt A, Langley RG, Lebwohl M, Strober B, Warren RB, Puig L, Morita A, Gordon KB, Fernandez-Penas P, Kavanagh S, Lopez Pinto JM, Lambert J, Hoepken B, Deherder D, Cross N, Thaci D. Bimekizumab durability of efficacy through 196 weeks and safety through 4 years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial. J Am Acad Dermatol. 2025 Sep;93(3):644-653. doi: 10.1016/j.jaad.2025.04.038. Epub 2025 Apr 24.
Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.
Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14.
Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4.
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.
FG002
Placebo/Placebo
Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.
FG003
Bimekizumab 320 mg Q4W/Placebo
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.
FG004
Bimekizumab 320 mg Q4W/Q8W
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
FG005
Bimekizumab 320 mg Q4W/Q4W
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period.
FG006
Placebo Escape
Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
FG007
Bimekizumab 320 mg Q4W Escape
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
FG008
Bimekizumab 320 mg Q4W/ Placebo Escape
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
FG009
Bimekizumab 320 mg Q4W/Q8W Escape
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
FG010
Bimekizumab 320 mg Q4W/Q4W Escape
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
FG00086 subjects
FG001349 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00082 subjects
FG001340 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0004 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Week 16 Assessment
Type
Comment
Milestone Data
STARTED
FG00082 subjects
FG001340 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received Escape Treatment
FG00081 subjects
FG00123 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0001 subjects
FG001311 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00081 subjects
FG00129 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
PASI90 Non-Response at Week 16
FG00081 subjects
FG00123 subjects
FG0020 subjects
FG003
Randomized-Withdrawal Period: up to Wk56
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003105 subjects
FG004100 subjects
FG005106 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received Escape Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00367 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG00333 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00372 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Escape Treatment: 12 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00681 subjects
FG00723 subjects
FG00867 subjects
FG0094 subjects
FG0107 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
BG001
Bimekizumab 320 mg Q4W
Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.
BG002
Total Title
Denominators
Units
Counts
Participants
BG00086
BG001349
BG002435
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0002
BG0011
BG0023
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.5± 13.1
BG00144.5± 12.9
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00194
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0005
BG00113
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response 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).
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (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.
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0001.2
OG00190.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
496.318
2-Sided
95
82.798
2975.086
Superiority
Primary
Percentage of Participants With an Investigator's Global Assessment (IGA) Response 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).
e Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (RS)
Secondary
Percentage of Participants With a PASI100 Response 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).
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (RS)
Secondary
Percentage of Participants With a IGA Clear Response 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).
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (RS)
Secondary
Percentage of Participants With a PASI75 Response 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.
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
At Week 4
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (RS)
Secondary
Percentage of Participants With a Patient Symptom Diary Response for Pain 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.
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.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Secondary
Percentage of Participants With a Patient Symptom Diary Response for Itch 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.
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.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (RS)
Secondary
Percentage of Participants With a Patient Symptom Diary Response for Scaling 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.
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.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Secondary
Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline
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.
The Randomized Set (RS) consisted of all randomized study participants.
Posted
Number
percentage of participants
At Week 16
ID
Title
Description
OG000
Placebo (RS)
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).
OG001
Bimekizumab 320 mg Q4W (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.
Secondary
Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders
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).
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.
Posted
Number
percentage of participants
At Week 56
ID
Title
Description
OG000
Bimekizumab 320 mg Q4W/Placebo (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.
OG001
Bimekizumab 320 mg Q4W/Q8W (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.
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
The Safety Set (SS) consisted of all study participants who received at least 1 dose of the IMP.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline to end of Initial Treatment Period (up to Week 16)
ID
Title
Description
OG000
Placebo (SS)
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).
OG001
Bimekizumab 320 mg Q4W (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.
Secondary
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
The Safety Set (SS) consisted of all study participants who received at least 1 dose of the IMP.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline to end of Initial Treatment Period (up to Week 16)
ID
Title
Description
OG000
Placebo (SS)
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).
OG001
Bimekizumab 320 mg Q4W (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.
Secondary
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
The Safety Set (SS) consisted of all study participants who received at least 1 dose of the IMP.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline to end of Initial Treatment Period (up to Week 16)
ID
Title
Description
OG000
Placebo (SS)
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).
OG001
Bimekizumab 320 mg Q4W (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.
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
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.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
ID
Title
Description
OG000
Placebo/Placebo (WK16ResS)
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).
OG001
Bimekizumab 320 mg Q4W/Placebo (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.
Secondary
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
ID
Title
Description
OG000
Placebo/Placebo (WK16ResS)
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).
OG001
Bimekizumab 320 mg Q4W/Placebo (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.
Secondary
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
ID
Title
Description
OG000
Placebo/Placebo (WK16ResS)
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).
OG001
Bimekizumab 320 mg Q4W/Placebo (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.
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
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.
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.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
ID
Title
Description
OG000
Placebo Escape (ESS)
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).
OG001
Bimekizumab 320 mg Q4W Escape (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.
Secondary
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
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.
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.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
ID
Title
Description
OG000
Placebo Escape (ESS)
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).
OG001
Bimekizumab 320 mg Q4W Escape (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.
Secondary
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
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.
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.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
ID
Title
Description
OG000
Placebo Escape (ESS)
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).
OG001
Bimekizumab 320 mg Q4W Escape (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.
Time Frame
Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)
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).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (SS)
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).
0
86
2
86
15
86
EG001
Bimekizumab 320 mg Q4W (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.
0
349
6
349
66
349
EG002
Placebo/Placebo (WK16ResS)
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).
0
1
0
1
1
1
EG003
Bimekizumab 320 mg Q4W/Placebo (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.
0
105
4
105
34
105
EG004
Bimekizumab 320 mg Q4W/Q8W (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.
0
100
3
100
40
100
EG005
Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
0
106
5
106
34
106
EG006
Placebo Escape (ESS)
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).
0
81
1
81
8
81
EG007
Bimekizumab 320 mg Q4W Escape (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.
0
23
0
23
5
23
EG008
Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive 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.
0
67
0
67
11
67
EG009
Bimekizumab 320 mg Q4W/Q8W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
0
4
0
4
3
4
EG010
Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
0
7
0
7
4
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected105 at risk
EG0040 events0 affected100 at risk
EG0050 events0 affected106 at risk
EG0060 events0 affected81 at risk
EG0070 events0 affected23 at risk
EG0080 events0 affected67 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected7 at risk
Mitral valve prolapse
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0001 events1 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Retinal detachment
Eye disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Enterovirus infection
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Cataract
Eye disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA19.0
Non-systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected349 at risk
EG0020 events0 affected1 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0001.2
OG00192.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
657.255
2-Sided
95
105.792
4083.333
Superiority
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.
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0001.2
OG00168.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
220.038
2-Sided
95
28.757
1683.639
Superiority
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.
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0001.2
OG00169.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
224.744
2-Sided
95
30.130
1676.425
Superiority
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.
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0001.2
OG00175.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
316.641
2-Sided
95
39.423
2543.254
Superiority
Bimekizumab 320 mg Q4W (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.
Units
Counts
Participants
OG00067
OG001255
Title
Denominators
Categories
Title
Measurements
OG0009.0
OG00178.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
34.325
2-Sided
95
14.220
82.856
Superiority
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.
Units
Counts
Participants
OG00072
OG001278
Title
Denominators
Categories
Title
Measurements
OG0005.6
OG00175.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
43.497
2-Sided
95
15.728
120.295
Superiority
Bimekizumab 320 mg Q4W (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.
Units
Counts
Participants
OG00070
OG001286
Title
Denominators
Categories
Title
Measurements
OG0005.7
OG00178.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
60.946
2-Sided
95
20.560
180.669
Superiority
Units
Counts
Participants
OG00074
OG001310
Title
Denominators
Categories
Title
Measurements
OG0006.8
OG00192.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
158.000
2-Sided
95
49.263
506.745
Superiority
OG002
Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
OG003
Bimekizumab 320 mg Q4W/Q8W+Q4W/Q4W (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.
Units
Counts
Participants
OG000105
OG001100
OG002106
OG003206
Title
Denominators
Categories
Title
Measurements
OG00016.2
OG00191.0
OG00286.8
OG00388.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
45.192
2-Sided
95
18.622
109.672
Superiority
OG000
OG002
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.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
49.297
2-Sided
95
18.887
128.673
Superiority
OG000
OG003
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.
Cochran-Mantel-Haenszel
<0.001
P-values for the comparison of treatment groups were based on the CMH test from the general association.
Odds Ratio (OR)
47.406
2-Sided
95
22.087
101.750
Superiority
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG000177.38(123.55 to 246.69)
OG001323.61(281.60 to 370.11)
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0007.66(0.93 to 27.68)
OG0015.59(2.05 to 12.17)
Units
Counts
Participants
OG00086
OG001349
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
OG0012.78(0.57 to 8.12)
OG002
Bimekizumab 320 mg Q4W/Q8W (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.
OG003
Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Units
Counts
Participants
OG0001
OG001105
OG002100
OG003106
Title
Denominators
Categories
Title
Measurements
OG000144.37(3.66 to 804.36)
OG001242.11(189.44 to 304.90)
OG002224.87(177.46 to 281.05)
OG003208.88(165.11 to 260.69)
OG002
Bimekizumab 320 mg Q4W/Q8W (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.
OG003
Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Units
Counts
Participants
OG0001
OG001105
OG002100
OG003106
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
OG0017.20(1.96 to 18.43)
OG0024.04(0.83 to 11.80)
OG0036.64(2.16 to 15.50)
OG002
Bimekizumab 320 mg Q4W/Q8W (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.
OG003
Bimekizumab 320 mg Q4W/Q4W (WK16ResS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.
Units
Counts
Participants
OG0001
OG001105
OG002100
OG003106
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
OG0015.33(1.10 to 15.58)
OG0022.69(0.33 to 9.71)
OG0030(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
OG002
Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive 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.
OG003
Bimekizumab 320 mg Q4W/Q8W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
OG004
Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
Units
Counts
Participants
OG00081
OG00123
OG00267
OG0034
OG0047
Title
Denominators
Categories
Title
Measurements
OG000235.86(164.29 to 328.03)
OG001287.19(143.36 to 513.86)
OG002180.89(115.90 to 269.15)
OG003491.37(101.33 to 1435.98)
OG004349.52(95.23 to 894.91)
OG002
Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive 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.
OG003
Bimekizumab 320 mg Q4W/Q8W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
OG004
Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
Units
Counts
Participants
OG00081
OG00123
OG00267
OG0034
OG0047
Title
Denominators
Categories
Title
Measurements
OG0005.24(0.13 to 29.22)
OG0010(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
OG0020(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
OG0030(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
OG0040(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.
OG002
Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive 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.
OG003
Bimekizumab 320 mg Q4W/Q8W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.
OG004
Bimekizumab 320 mg Q4W/Q4W Escape (ESS)
Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.
Units
Counts
Participants
OG00081
OG00123
OG00267
OG0034
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
OG00118.77(0.48 to 104.58)
OG0020(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
OG0030(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.
OG0040(NA to NA)Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.