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
NCT ID: NCT03410992
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
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COMPLETED
PHASE3
435 participants
INTERVENTIONAL
2018-02-05
2020-01-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bimekizumab cohort
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.
Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Placebo
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.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Bimekizumab Escape arm
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.
Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Interventions
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Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Ps0013 919
San Diego, California, United States
Ps0013 955
San Diego, California, United States
Ps0013 967
Santa Monica, California, United States
Ps0013 928
Fort Myers, Florida, United States
Ps0013 966
Sandy Springs, Georgia, United States
Ps0013 954
Skokie, Illinois, United States
Ps0013 962
Owensboro, Kentucky, United States
Ps0013 944
New Orleans, Louisiana, United States
Ps0013 940
Beverly, Massachusetts, United States
Ps0013 901
Portsmouth, New Hampshire, United States
Ps0013 956
Verona, New Jersey, United States
Ps0013 947
Buffalo, New York, United States
Ps0013 968
New York, New York, United States
Ps0013 965
New York, New York, United States
Ps0013 963
Rochester, New York, United States
Ps0013 949
Cleveland, Ohio, United States
Ps0013 929
Portland, Oregon, United States
Ps0013 937
Johnston, Rhode Island, United States
Ps0013 914
San Antonio, Texas, United States
Ps0013 933
Murray, Utah, United States
Ps0013 003
Carlton, , Australia
Ps0013 008
East Melbourne, , Australia
Ps0013 006
Kogarah, , Australia
Ps0013 658
Ajax, , Canada
Ps0013 672
Edmonton, , Canada
Ps0013 671
Hamilton, , Canada
Ps0013 675
Markham, , Canada
Ps0013 663
Mississauga, , Canada
Ps0013 660
Montreal, , Canada
Ps0013 668
North Bay, , Canada
Ps0013 667
Ottawa, , Canada
Ps0013 665
Québec, , Canada
Ps0013 676
Surrey, , Canada
Ps0013 657
Waterloo, , Canada
Ps0013 202
Hamburg, , Germany
Ps0013 220
Hamburg, , Germany
Ps0013 219
Münster, , Germany
Ps0013 200
Schwerin, , Germany
Ps0013 204
Witten, , Germany
Ps0013 261
Budapest, , Hungary
Ps0013 262
Miskolc, , Hungary
Ps0013 253
Orosháza, , Hungary
Ps0013 260
Szeged, , Hungary
Ps0013 250
Szolnok, , Hungary
Ps0013 258
Veszprém, , Hungary
Ps0013 355
Bialystok, , Poland
Ps0013 361
Bialystok, , Poland
Ps0013 369
Bialystok, , Poland
Ps0013 352
Gdansk, , Poland
Ps0013 358
Katowice, , Poland
Ps0013 359
Katowice, , Poland
Ps0013 366
Katowice, , Poland
Ps0013 357
Kielce, , Poland
Ps0013 363
Krakow, , Poland
Ps0013 360
Lodz, , Poland
Ps0013 356
Lublin, , Poland
Ps0013 374
Poznan, , Poland
Ps0013 353
Szczecin, , Poland
Ps0013 350
Warsaw, , Poland
Ps0013 351
Warsaw, , Poland
Ps0013 354
Warsaw, , Poland
Ps0013 365
Wroclaw, , Poland
Ps0013 368
Wroclaw, , Poland
Ps0013 370
Wroclaw, , Poland
Ps0013 400
Moscow, , Russia
Ps0013 402
Moscow, , Russia
Ps0013 403
Moscow, , Russia
Ps0013 404
Saint Petersburg, , Russia
Ps0013 405
Saint Petersburg, , Russia
Ps0013 401
Saratov, , Russia
Ps0013 406
Yaroslavl, , Russia
Ps0013 701
Busan, , South Korea
Ps0013 705
Seongnam-si, , South Korea
Ps0013 703
Seoul, , South Korea
Ps0013 550
Manchester, , United Kingdom
Ps0013 554
Reading, , United Kingdom
Ps0013 555
Salford, , United Kingdom
Countries
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References
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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.
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.
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, 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2016-003426-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0013
Identifier Type: -
Identifier Source: org_study_id