A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT03536884
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
743 participants
INTERVENTIONAL
2018-06-13
2023-08-09
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 dosage regimen 1
Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).
At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Bimekizumab dosage regimen 2
Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Secukinumab
Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Secukinumab
Subjects will receive secukinumab at pre-specified time-points.
Interventions
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Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Secukinumab
Subjects will receive secukinumab at pre-specified time-points.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female at least 18 years of age
* Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
* Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
* Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
* Female subject of childbearing potential must be willing to use highly effective method of contraception
Open-label extension (OLE) Period
* Completed the double-blind Treatment Period without meeting any withdrawal criteria
* All Week 48 visit assessments completed
* Compliant with ongoing clinical study requirements
* Signed a separate OLE Period Informed Consent Form (ICF)
* Female subject of childbearing potential must be willing to use highly effective method of contraception
OLE2 Period (USA and Canada)
* Completed the OLE Period without meeting any withdrawal criteria
* Compliant with ongoing clinical study requirements
* Female subject of childbearing potential must be willing to use highly effective method of contraception
* Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
* Signed a separate OLE2 Period ICF
Exclusion Criteria
* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or 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
* Presence of active suicidal ideation or severe 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
OLE2 Period (USA and Canada)
* Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
* Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
* Presence of active suicidal ideation or severe depression
* Subject has developed any active malignancy or history of malignancy prior to the OLE2 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
Locations
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Ps0015 975
Santa Ana, California, United States
Ps0015 939
Danbury, Connecticut, United States
Ps0015 903
Ocala, Florida, United States
Ps0015 921
Ormond Beach, Florida, United States
Ps0015 977
Pembroke Pines, Florida, United States
Ps0015 936
Tampa, Florida, United States
Ps0015 976
Tampa, Florida, United States
Ps0015 970
West Palm Beach, Florida, United States
Ps0015 966
Sandy Springs, Georgia, United States
Ps0015 954
Skokie, Illinois, United States
Ps0015 972
West Dundee, Illinois, United States
Ps0015 900
West Des Moines, Iowa, United States
Ps0015 944
New Orleans, Louisiana, United States
Ps0015 915
Clayton, Missouri, United States
Ps0015 953
St Louis, Missouri, United States
Ps0015 901
Portsmouth, New Hampshire, United States
Ps0015 965
Kew Gardens, New York, United States
Ps0015 969
High Point, North Carolina, United States
Ps0015 971
Wilmington, North Carolina, United States
Ps0015 980
Bexley, Ohio, United States
Ps0015 920
Portland, Oregon, United States
Ps0015 929
Portland, Oregon, United States
Ps0015 979
Dallas, Texas, United States
Ps0015 924
Houston, Texas, United States
Ps0015 978
Pflugerville, Texas, United States
PS0015 3
Carlton, , Australia
PS0015 7
Hectorville, , Australia
PS0015 6
Kogarah, , Australia
Ps0015 11
Parkville, , Australia
PS0015 9
Woolloongabba, , Australia
Ps0015 50
Brussels, , Belgium
Ps0015 54
Brussels, , Belgium
Ps0015 52
Liège, , Belgium
Ps0015 673
Halifax, , Canada
Ps0015 671
Hamilton, , Canada
Ps0015 663
Mississauga, , Canada
Ps0015 661
Peterborough, , Canada
Ps0015 678
Richmond Hill, , Canada
Ps0015 677
Toronto, , Canada
Ps0015 657
Waterloo, , Canada
Ps0015 153
Toulouse, , France
Ps0015 223
Augsburg, , Germany
Ps0015 237
Berlin, , Germany
Ps0015 211
Hamburg, , Germany
Ps0015 215
Lübeck, , Germany
Ps0015 213
Mahlow, , Germany
Ps0015 238
Mainz, , Germany
Ps0015 234
München, , Germany
Ps0015 219
Münster, , Germany
Ps0015 236
Neu-Ulm, , Germany
Ps0015 222
Tübingen, , Germany
Ps0015 204
Witten, , Germany
Ps0015 265
Amsterdam, , Netherlands
Ps0015 263
Breda, , Netherlands
Ps0015 355
Bialystok, , Poland
Ps0015 361
Bialystok, , Poland
Ps0015 369
Bialystok, , Poland
Ps0015 352
Gdansk, , Poland
Ps0015 366
Katowice, , Poland
Ps0015 378
Katowice, , Poland
Ps0015 376
Krakow, , Poland
Ps0015 379
Krakow, , Poland
Ps0015 372
Lodz, , Poland
Ps0015 377
Ostrowiec Świętokrzyski, , Poland
Ps0015 368
Wroclaw, , Poland
Ps0015 375
Wroclaw, , Poland
Ps0015 455
Alicante, , Spain
Ps0015 450
Barcelona, , Spain
Ps0015 451
Madrid, , Spain
Ps0015 454
Madrid, , Spain
Ps0015 456
Madrid, , Spain
Ps0015 457
Sant Joan Despí, , Spain
Ps0015 763
Gaziantep, , Turkey (Türkiye)
Ps0015 762
Istanbul, , Turkey (Türkiye)
Ps0015 760
Kayseri, , Turkey (Türkiye)
Ps0015 559
Newcastle upon Tyne, , United Kingdom
Ps0015 555
Salford, , United Kingdom
Countries
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References
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Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.
Lebwohl M, Merola JF, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb AB. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. J Am Acad Dermatol. 2024 Aug;91(2):281-289. doi: 10.1016/j.jaad.2024.03.041. Epub 2024 Apr 6.
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.
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.
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.
Warren RB, Lebwohl M, Thaci D, Gooderham M, Pinter A, Paul C, Gisondi P, Szilagyi B, White K, Deherder D, Staelens F, Lambert J, Strober B. Bimekizumab efficacy and safety through 3 years in patients with moderate-to-severe plaque psoriasis: long-term results from the BE RADIANT phase IIIb trial open-label extension period. Br J Dermatol. 2025 Jun 20;193(1):44-55. doi: 10.1093/bjd/ljaf032.
Augustin M, Gottlieb AB, Lebwohl M, Pinter A, Warren RB, Puig L, Warham R, Lambert J, Wiegratz S, Szilagyi B, Blauvelt A. Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2841-2857. doi: 10.1007/s13555-024-01261-6. Epub 2024 Sep 17.
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.
Gottlieb AB, Warren RB, Augustin M, 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 Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.
Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.
Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2017-003784-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0015
Identifier Type: -
Identifier Source: org_study_id