Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
BE ABLE 1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
2 other identifiers
interventional
250
6 countries
41
Brief Summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2016
Shorter than P25 for phase_2
41 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
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
November 19, 2020
CompletedJuly 21, 2022
July 1, 2022
10 months
September 14, 2016
June 8, 2020
July 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 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 minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 12
Secondary Outcomes (35)
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
Week 12
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
Week 8
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
Week 8
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
Week 12
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Week 12
- +30 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORBimekizumab dosing regimen 1
EXPERIMENTALBimekizumab dosing regimen 2
EXPERIMENTALBimekizumab dosing regimen 3
EXPERIMENTALBimekizumab dosing regimen 4
EXPERIMENTALBimekizumab dosing regimen 5
EXPERIMENTALInterventions
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Eligibility Criteria
You may qualify if:
- Subject has provided informed consent
- Chronic plaque psoriasis for at least 6 months prior to Screening
- PASI (Psoriasis Area and Severity Index) \>=12 and BSA (body surface area) \>=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication
You may not qualify if:
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
- Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
- Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
- Subject taking prohibited psoriatic medications
- Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
- Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
- Subject has any current sign or symptom that may indicate an active infection (except for common cold)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Biopharma S.P.R.L.lead
- Parexelcollaborator
Study Sites (41)
Ps0010 711
Fremont, California, United States
Ps0010 708
Los Angeles, California, United States
Ps0010 706
Washington D.C., District of Columbia, United States
Ps0010 704
West Des Moines, Iowa, United States
Ps0010 718
Rochester, New York, United States
Ps0010 738
Wilmington, North Carolina, United States
Ps0010 736
Cleveland, Ohio, United States
Ps0010 712
Portland, Oregon, United States
Ps0010 733
Dallas, Texas, United States
Ps0010 702
Houston, Texas, United States
Ps0010 709
Houston, Texas, United States
Ps0010 203
Surrey, British Columbia, Canada
Ps0010 204
Hamilton, Ontario, Canada
Ps0010 201
North Bay, Ontario, Canada
Ps0010 206
Peterborough, Ontario, Canada
Ps0010 205
Waterloo, Ontario, Canada
Ps0010 214
Québec, Quebec, Canada
Ps0010 209
Edmonton, Canada
Ps0010 214
Québec, Canada
Ps0010 300
Ostrava Poruba, Czechia
Ps0010 303
Pardubice, Czechia
Ps0010 301
Prague, Czechia
Ps0010 304
Prague, Czechia
Ps0010 404
Kecskemét, Hungary
Ps0010 400
Orosháza, Hungary
Ps0010 405
Szekszárd, Hungary
Ps0010 502
Nagoya, Japan
Ps0010 501
Shinaga Wa-ku, Japan
Ps0010 503
Tokyo, Japan
Ps0010 504
Tokyo, Japan
Ps0010 600
Bialystok, Poland
Ps0010 611
Bialystok, Poland
Ps0010 605
Gdansk, Poland
Ps0010 610
Gdynia, Poland
Ps0010 604
Kielce, Poland
Ps0010 608
Krakow, Poland
Ps0010 606
Lublin, Poland
Ps0010 603
Podlaski, Poland
Ps0010 607
Warsaw, Poland
Ps0010 601
Wroclaw, Poland
Ps0010 609
Wroclaw, Poland
Related Publications (1)
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.
PMID: 35544084RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- 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
September 14, 2016
First Posted
September 19, 2016
Study Start
August 1, 2016
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
July 21, 2022
Results First Posted
November 19, 2020
Record last verified: 2022-07