A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT03412747
Last Updated: 2025-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
478 participants
INTERVENTIONAL
2018-01-26
2020-02-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bimekizumab Arm 1
Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Bimekizumab Arm 2
Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Adalimumab Arm
Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic plaque 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 serious infection, or a history of opportunistic or recurrent 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
* Subject has had previous exposure to adalimumab
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Biopharma SRL
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ps0008 957
Glendale, Arizona, United States
Ps0008 927
Los Angeles, California, United States
Ps0008 955
San Diego, California, United States
Ps0008 943
San Luis Obispo, California, United States
Ps0008 967
Santa Monica, California, United States
Ps0008 939
Danbury, Connecticut, United States
Ps0008 934
Washington D.C., District of Columbia, United States
Ps0008 906
Boca Raton, Florida, United States
Ps0008 936
Tampa, Florida, United States
Ps0008 900
West Des Moines, Iowa, United States
Ps0008 905
Overland Park, Kansas, United States
Ps0008 940
Beverly, Massachusetts, United States
Ps0008 925
Brighton, Massachusetts, United States
Ps0008 917
Troy, Michigan, United States
Ps0008 908
East Windsor, New Jersey, United States
Ps0008 961
Rocky Mount, North Carolina, United States
Ps0008 935
Winston-Salem, North Carolina, United States
Ps0008 932
Oklahoma City, Oklahoma, United States
Ps0008 929
Portland, Oregon, United States
Ps0008 945
Greer, South Carolina, United States
Ps0008 931
Dallas, Texas, United States
Ps0008 924
Houston, Texas, United States
Ps0008 951
Houston, Texas, United States
Ps0008 008
East Melbourne, , Australia
Ps0008 004
Fremantle, , Australia
Ps0008 007
Hectorville, , Australia
Ps0008 010
Kogarah, , Australia
Ps0008 005
Phillip, , Australia
Ps0008 009
Woolloongabba, , Australia
Ps0008 659
Calgary, , Canada
Ps0008 663
Mississauga, , Canada
Ps0008 660
Montreal, , Canada
Ps0008 661
Peterborough, , Canada
Ps0008 662
Toronto, , Canada
Ps0008 664
Toronto, , Canada
Ps0008 657
Waterloo, , Canada
Ps0008 669
Windsor, , Canada
Ps0008 670
Windsor, , Canada
Ps0008 674
Winnipeg, , Canada
Ps0008 207
Berlin, , Germany
Ps0008 218
Bonn, , Germany
Ps0008 203
Dresden, , Germany
Ps0008 211
Hamburg, , Germany
Ps0008 220
Hamburg, , Germany
Ps0008 215
Lübeck, , Germany
Ps0008 213
Mahlow, , Germany
Ps0008 205
Osnabrück, , Germany
Ps0008 217
Schweinfurt, , Germany
Ps0008 252
Budapest, , Hungary
Ps0008 254
Budapest, , Hungary
Ps0008 255
Budapest, , Hungary
Ps0008 256
Debrecen, , Hungary
Ps0008 251
Gyula, , Hungary
Ps0008 260
Szeged, , Hungary
Ps0008 355
Bialystok, , Poland
Ps0008 362
Bialystok, , Poland
Ps0008 371
Bydgoszcz, , Poland
Ps0008 352
Gdansk, , Poland
Ps0008 359
Katowice, , Poland
Ps0008 366
Katowice, , Poland
Ps0008 363
Krakow, , Poland
Ps0008 360
Lodz, , Poland
Ps0008 372
Lodz, , Poland
Ps0008 356
Lublin, , Poland
Ps0008 364
Nowa Sól, , Poland
Ps0008 353
Szczecin, , Poland
Ps0008 354
Warsaw, , Poland
Ps0008 365
Wroclaw, , Poland
Ps0008 367
Wroclaw, , Poland
Ps0008 373
Wroclaw, , Poland
Ps0008 405
Saint Petersburg, , Russia
Ps0008 401
Saratov, , Russia
Ps0008 406
Yaroslavl, , Russia
Ps0008 702
Gwangju, , South Korea
Ps0008 700
Seoul, , South Korea
Ps0008 754
Taipei, , Taiwan
Ps0008 755
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021.
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.
Strober B, Boehncke WH, Krueger JG, Magnolo N, Vender R, Warren RB, Lopez Pinto JM, Kavanagh S, Hoepken B, Gisondi P. Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3633-3650. doi: 10.1007/s13555-025-01557-1. Epub 2025 Oct 8.
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). 2025 Dec 8. doi: 10.1007/s13555-025-01595-9. Online ahead of print.
Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31.
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.
Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.
Warren RB, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):130-141. doi: 10.1056/NEJMoa2102388. Epub 2021 Apr 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-003392-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0008
Identifier Type: -
Identifier Source: org_study_id