A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
BE ABLE 2
A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
2 other identifiers
interventional
217
6 countries
36
Brief Summary
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2016
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2018
CompletedResults Posted
Study results publicly available
October 25, 2021
CompletedOctober 18, 2022
September 1, 2022
1.8 years
January 3, 2017
September 24, 2021
September 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
From Baseline until Safety Follow-Up Visit (up to Week 64)
Secondary Outcomes (2)
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
From Baseline during the Treatment Period (up to Week 48)
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
From Baseline during the Treatment Period (up to Week 48)
Study Arms (4)
Placebo
PLACEBO COMPARATORSubjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.
Bimekizumab dosing regimen 1
EXPERIMENTALSubjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.
Bimekizumab dosing regimen 2
EXPERIMENTALSubjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.
Bimekizumab dosing regimen 3
EXPERIMENTALSubjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.
Interventions
Subjects will receive bimekizumab injections every four weeks (Q4W)
Eligibility Criteria
You may qualify if:
- Subject has provided informed consent
- Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
- Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011
You may not qualify if:
- Subject has previously participated in this study.
- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
- Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Ps0011 708
Los Angeles, California, 90045, United States
Ps0011 706
Washington D.C., District of Columbia, 20037, United States
Ps0011 704
West Des Moines, Iowa, 50265, United States
Ps0011 738
Wilmington, North Carolina, 28405, United States
Ps0011 712
Portland, Oregon, 97223, United States
Ps0011 733
Dallas, Texas, 75231, United States
Ps0011 709
Houston, Texas, 77004, United States
Ps0011 702
Houston, Texas, 77598, United States
Ps0011 209
Edmonton, Canada
Ps0011 201
North Bay, Canada
Ps0011 206
Peterborough, Canada
Ps0011 214
Québec, Canada
Ps0011 203
Surrey, Canada
Ps0011 205
Waterloo, Canada
Ps0011 300
Ostrava, Czechia
Ps0011 303
Pardubice, Czechia
Ps0011 301
Prague, Czechia
Ps0011 304
Prague, Czechia
Ps0011 404
Kecskemét, Hungary
Ps0011 400
Orosháza, Hungary
Ps0011 405
Szekszárd, Hungary
Ps0011 504
Chiyoda-ku, Japan
Ps0011 503
Minatoku, Japan
Ps0011 502
Nagoya, Japan
Ps0011 501
Shinagawa-ku, Japan
Ps0011 600
Bialystok, Poland
Ps0011 603
Bialystok, Poland
Ps0011 611
Bialystok, Poland
Ps0011 610
Gdynia, Poland
Ps0011 604
Kielce, Poland
Ps0011 608
Krakow, Poland
Ps0011 605
Lublin, Poland
Ps0011 606
Lublin, Poland
Ps0011 607
Warsaw, Poland
Ps0011 601
Wroclaw, Poland
Ps0011 609
Wroclaw, Poland
Related Publications (2)
Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
PMID: 32473974RESULTGordon 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.
PMID: 35544084RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 5, 2017
Study Start
December 14, 2016
Primary Completion
September 25, 2018
Study Completion
September 25, 2018
Last Updated
October 18, 2022
Results First Posted
October 25, 2021
Record last verified: 2022-09