A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT03370133
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
567 participants
INTERVENTIONAL
2017-12-06
2019-12-13
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 52 weeks.
Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Ustekinumab cohort
Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.
Ustekinumab
Ustekinumab will be provided as dose 1 for subjects weighing \<=100 kg and as dose 2 for subjects weighing \>100 kg at pre-specified time intervals.
Placebo
Subjects will receive Placebo at pre-specified time points.
Placebo
Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.
Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Placebo
Subjects will receive Placebo at pre-specified time points.
Interventions
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Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Ustekinumab
Ustekinumab will be provided as dose 1 for subjects weighing \<=100 kg and as dose 2 for subjects weighing \>100 kg at pre-specified time intervals.
Placebo
Subjects will receive Placebo at pre-specified time points.
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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Ps0009 946
Phoenix, Arizona, United States
Ps0009 910
Bakersfield, California, United States
Ps0009 919
San Diego, California, United States
Ps0009 906
Boca Raton, Florida, United States
Ps0009 909
Boynton Beach, Florida, United States
Ps0009 912
Coral Gables, Florida, United States
Ps0009 907
Miami, Florida, United States
Ps0009 903
Ocala, Florida, United States
Ps0009 921
Ormond Beach, Florida, United States
Ps0009 918
Tampa, Florida, United States
Ps0009 941
Alpharetta, Georgia, United States
Ps0009 911
Plainfield, Indiana, United States
Ps0009 900
West Des Moines, Iowa, United States
Ps0009 905
Overland Park, Kansas, United States
Ps0009 922
Baton Rouge, Louisiana, United States
Ps0009 917
Troy, Michigan, United States
Ps0009 915
St Louis, Missouri, United States
Ps0009 958
Omaha, Nebraska, United States
Ps0009 901
Portsmouth, New Hampshire, United States
Ps0009 908
East Windsor, New Jersey, United States
Ps0009 923
Albuquerque, New Mexico, United States
Ps0009 913
New York, New York, United States
Ps0009 920
Portland, Oregon, United States
Ps0009 924
Houston, Texas, United States
Ps0009 914
San Antonio, Texas, United States
Ps0009 004
Fremantle, , Australia
Ps0009 005
Phillip, , Australia
Ps0009 002
Westmead, , Australia
Ps0009 009
Woolloongabba, , Australia
Ps0009 050
Brussels, , Belgium
Ps0009 052
Liège, , Belgium
Ps0009 051
Loverval, , Belgium
Ps0009 673
Halifax, , Canada
Ps0009 652
Oakville, , Canada
Ps0009 651
Richmond Hill, , Canada
Ps0009 650
Surrey, , Canada
Ps0009 653
Toronto, , Canada
Ps0009 657
Waterloo, , Canada
Ps0009 218
Bonn, , Germany
Ps0009 209
Darmstadt, , Germany
Ps0009 214
Erlangen, , Germany
Ps0009 208
Frankfurt am Main, , Germany
Ps0009 210
Friedrichshafen, , Germany
Ps0009 211
Hamburg, , Germany
Ps0009 212
Heidelberg, , Germany
Ps0009 213
Mahlow, , Germany
Ps0009 205
Osnabrück, , Germany
Ps0009 217
Schweinfurt, , Germany
Ps0009 254
Budapest, , Hungary
Ps0009 255
Budapest, , Hungary
Ps0009 253
Orosháza, , Hungary
Ps0009 259
Szekszárd, , Hungary
Ps0009 300
Roma, , Italy
Ps0009 303
Roma, , Italy
Ps0009 629
Asahikawa, , Japan
Ps0009 605
Bunkyō City, , Japan
Ps0009 607
Chiyoda City, , Japan
Ps0009 610
Chūōku, , Japan
Ps0009 601
Fukuoka, , Japan
Ps0009 619
Gifu, , Japan
Ps0009 620
Hamamatsu, , Japan
Ps0009 608
Itabashi-Ku, , Japan
Ps0009 627
Itabashi-Ku, , Japan
Ps0009 609
Kobe, , Japan
Ps0009 600
Kurume, , Japan
Ps0009 622
Matsumoto, , Japan
Ps0009 604
Minatoku, , Japan
Ps0009 623
Morioka, , Japan
Ps0009 621
Nagoya, , Japan
Ps0009 625
Nankoku, , Japan
Ps0009 624
Obihiro, , Japan
Ps0009 611
Osaka, , Japan
Ps0009 614
Osaka, , Japan
Ps0009 603
Sapporo, , Japan
Ps0009 617
Sendai, , Japan
Ps0009 613
Shimotsuke, , Japan
Ps0009 602
Shinagawa-Ku, , Japan
Ps0009 612
Shinjuku-Ku, , Japan
Ps0009 618
Shinjuku-Ku, , Japan
Ps0009 626
Shinjuku-Ku, , Japan
Ps0009 628
Shinjuku-Ku, , Japan
Ps0009 615
Sumida City, , Japan
Ps0009 606
Takaoka, , Japan
Ps0009 616
Tsu, , Japan
Ps0009 362
Bialystok, , Poland
Ps0009 369
Bialystok, , Poland
Ps0009 371
Bydgoszcz, , Poland
Ps0009 358
Katowice, , Poland
Ps0009 357
Kielce, , Poland
Ps0009 372
Lodz, , Poland
Ps0009 374
Poznan, , Poland
Ps0009 350
Warsaw, , Poland
Ps0009 351
Warsaw, , Poland
Ps0009 367
Wroclaw, , Poland
Ps0009 370
Wroclaw, , Poland
Ps0009 400
Moscow, , Russia
Ps0009 402
Moscow, , Russia
Ps0009 403
Moscow, , Russia
Ps0009 404
Saint Petersburg, , Russia
Ps0009 556
Cardiff, , United Kingdom
Ps0009 551
Dundee, , United Kingdom
Ps0009 553
Edgbaston, , United Kingdom
Ps0009 552
Liverpool, , United Kingdom
Ps0009 550
Manchester, , United Kingdom
Ps0009 555
Salford, , United Kingdom
Countries
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References
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Asahina A, Okubo Y, Morita A, Tada Y, Igarashi A, Langley RG, Deherder D, Matano M, Vanvoorden V, Wang M, Ohtsuki M, Nakagawa H. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.
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, 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, 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.
Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021 Feb 6;397(10273):487-498. doi: 10.1016/S0140-6736(21)00125-2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003425-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0009
Identifier Type: -
Identifier Source: org_study_id