A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
BE BRIGHT
A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
2 other identifiers
interventional
1,353
13 countries
189
Brief Summary
This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2018
Longer than P75 for phase_3
189 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
First Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2023
CompletedResults Posted
Study results publicly available
December 6, 2024
CompletedApril 15, 2026
April 1, 2026
5.2 years
July 16, 2018
November 8, 2024
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Secondary Outcomes (6)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
Week 144 compared to Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
- +1 more secondary outcomes
Study Arms (2)
Bimekizumab dose regimen 1
EXPERIMENTALSubjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48) Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks. Intervention Name: Bimekizumab
Bimekizumab dose regimen 2
EXPERIMENTALSubjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label). Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2. Intervention Name: Bimekizumab
Interventions
Subjects will receive bimekizumab at pre-specified time-points.
Eligibility Criteria
You may qualify if:
- Treatment Period (open-label)
- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
- Subject completes the feeder study (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], PS0013 \[NCT03410992\]) without meeting any withdrawal criteria
- Female subjects must be:
- Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
- Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
- Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014
- 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
You may not qualify if:
- Treatment Period (open-label)
- Subject has previously participated in this study
- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
- Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
- Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
- Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen
- OLE2 Period (USA and Canada)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (189)
Ps0014 957
Glendale, Arizona, 85308, United States
Ps0014 946
Phoenix, Arizona, 85032, United States
Ps0014 910
Bakersfield, California, 93309, United States
Ps0014 927
Los Angeles, California, 90033, United States
Ps0014 919
San Diego, California, 92103, United States
Ps0014 955
San Diego, California, 92123, United States
Ps0014 943
San Luis Obispo, California, 93405, United States
Ps0014 967
Santa Monica, California, 90404, United States
Ps0014 934
Washington D.C., District of Columbia, 20016, United States
Ps0014 909
Boynton Beach, Florida, 33437, United States
Ps0014 912
Coral Gables, Florida, 33134, United States
Ps0014 928
Fort Myers, Florida, 33912, United States
Ps0014 906
Hollywood, Florida, 33021, United States
Ps0014 907
Miami, Florida, 33144, United States
Ps0014 903
Ocala, Florida, 34470, United States
Ps0014 921
Ormond Beach, Florida, 32174, United States
Ps0014 936
Tampa, Florida, 33613, United States
Ps0014 941
Alpharetta, Georgia, 30022, United States
Ps0014 954
Skokie, Illinois, 60077, United States
Ps0014 911
Plainfield, Indiana, 46168, United States
Ps0014 900
West Des Moines, Iowa, 50265, United States
Ps0014 905
Overland Park, Kansas, 66210, United States
Ps0014 962
Owensboro, Kentucky, 42301, United States
Ps0014 922
Baton Rouge, Louisiana, 70809, United States
Ps0014 944
New Orleans, Louisiana, 70115, United States
Ps0014 940
Beverly, Massachusetts, 01915, United States
Ps0014 925
Brighton, Massachusetts, 02135, United States
Ps0014 917
Troy, Michigan, 48084, United States
Ps0014 915
Clayton, Missouri, 63105, United States
Ps0014 958
Omaha, Nebraska, 68144, United States
Ps0014 901
Portsmouth, New Hampshire, 03801, United States
Ps0014 908
East Windsor, New Jersey, 08520, United States
Ps0014 956
Verona, New Jersey, 07044, United States
Ps0014 947
Buffalo, New York, 14221, United States
Ps0014 965
Kew Gardens, New York, 11415, United States
Ps0014 913
New York, New York, 10029-6501, United States
Ps0014 963
Rochester, New York, 14623, United States
Ps0014 961
Rocky Mount, North Carolina, 27804, United States
Ps0014 932
Oklahoma City, Oklahoma, 73112, United States
Ps0014 920
Portland, Oregon, 97210, United States
Ps0014 929
Portland, Oregon, 97223, United States
Ps0014 937
Johnston, Rhode Island, 02919, United States
Ps0014 945
Greer, South Carolina, 29650, United States
Ps0014 931
Dallas, Texas, 75231, United States
Ps0014 924
Houston, Texas, 77004, United States
Ps0014 914
San Antonio, Texas, 78213, United States
Ps0014 951
Webster, Texas, 77598, United States
Ps0014 933
Murray, Utah, 84107, United States
PS0014 7
Campbelltown, Australia
PS0014 3
Carlton, Australia
PS0014 8
East Melbourne, Australia
PS0014 4
Fremantle, Australia
Ps0014 10
Kogarah, Australia
PS0014 6
Kogarah, Australia
PS0014 5
Phillip, Australia
PS0014 2
Westmead, Australia
PS0014 9
Woolloongabba, Australia
Ps0014 50
Brussels, Belgium
Ps0014 51
Charleroi, Belgium
Ps0014 52
Liège, Belgium
Ps0014 658
Ajax, Canada
Ps0014 659
Calgary, Canada
Ps0014 672
Edmonton, Canada
Ps0014 673
Halifax, Canada
Ps0014 671
Hamilton, Canada
Ps0014 675
Markham, Canada
Ps0014 663
Mississauga, Canada
Ps0014 660
Montreal, Canada
Ps0014 668
North Bay, Canada
Ps0014 652
Oakville, Canada
Ps0014 667
Ottawa, Canada
Ps0014 661
Peterborough, Canada
Ps0014 665
Québec, Canada
Ps0014 651
Richmond Hill, Canada
Ps0014 650
Surrey, Canada
Ps0014 676
Surrey, Canada
Ps0014 653
Toronto, Canada
Ps0014 662
Toronto, Canada
Ps0014 664
Toronto, Canada
Ps0014 657
Waterloo, Canada
Ps0014 669
Windsor, Canada
Ps0014 670
Windsor, Canada
Ps0014 674
Winnipeg, Canada
Ps0014 207
Berlin, Germany
Ps0014 218
Bonn, Germany
Ps0014 209
Darmstadt, Germany
Ps0014 203
Dresden, Germany
Ps0014 214
Erlangen, Germany
Ps0014 208
Frankfurt, Germany
Ps0014 210
Friedrichshafen, Germany
Ps0014 202
Hamburg, Germany
Ps0014 211
Hamburg, Germany
Ps0014 220
Hamburg, Germany
Ps0014 212
Heidelberg, Germany
Ps0014 215
Lübeck, Germany
Ps0014 213
Mahlow, Germany
Ps0014 219
Münster, Germany
Ps0014 205
Osnabrück, Germany
Ps0014 217
Schweinfurt, Germany
Ps0014 200
Schwerin, Germany
Ps0014 204
Witten, Germany
Ps0014 252
Budapest, Hungary
Ps0014 254
Budapest, Hungary
Ps0014 255
Budapest, Hungary
Ps0014 261
Budapest, Hungary
Ps0014 256
Debrecen, Hungary
Ps0014 262
Encs, Hungary
Ps0014 251
Gyula, Hungary
Ps0014 253
Orosháza, Hungary
Ps0014 260
Szeged, Hungary
Ps0014 259
Szekszárd, Hungary
Ps0014 250
Szolnok, Hungary
Ps0014 258
Veszprém, Hungary
Ps0014 300
Roma, Italy
Ps0014 303
Roma, Italy
Ps0014 629
Asahikawa, Japan
Ps0014 605
Bunkyō City, Japan
Ps0014 607
Chiyoda-ku, Japan
Ps0014 610
Chūōku, Japan
Ps0014 601
Fukuoka, Japan
Ps0014 619
Gifu, Japan
Ps0014 620
Hamamatsu, Japan
Ps0014 608
Itabashi-ku, Japan
Ps0014 609
Kobe, Japan
Ps0014 600
Kurume, Japan
Ps0014 622
Matsumoto, Japan
Ps0014 604
Minatoku, Japan
Ps0014 623
Morioka, Japan
Ps0014 621
Nagoya, Japan
Ps0014 625
Nankoku, Japan
Ps0014 624
Obihiro, Japan
Ps0014 611
Osaka, Japan
Ps0014 614
Osaka, Japan
Ps0014 603
Sapporo, Japan
Ps0014 617
Sendai, Japan
Ps0014 613
Shimotsuke, Japan
Ps0014 602
Shinagawa-ku, Japan
Ps0014 612
Shinjuku-ku, Japan
Ps0014 618
Shinjuku-ku, Japan
Ps0014 626
Shinjuku-ku, Japan
Ps0014 628
Shinjuku-ku, Japan
Ps0014 606
Takaoka, Japan
Ps0014 615
Tokyo, Japan
Ps0014 627
Tokyo, Japan
Ps0014 616
Tsu, Japan
Ps0014 355
Bialystok, Poland
Ps0014 361
Bialystok, Poland
Ps0014 362
Bialystok, Poland
Ps0014 369
Bialystok, Poland
Ps0014 371
Bydgoszcz, Poland
Ps0014 352
Gdansk, Poland
Ps0014 358
Katowice, Poland
Ps0014 359
Katowice, Poland
Ps0014 366
Katowice, Poland
Ps0014 357
Kielce, Poland
Ps0014 363
Krakow, Poland
Ps0014 360
Lodz, Poland
Ps0014 372
Lodz, Poland
Ps0014 356
Lublin, Poland
Ps0014 364
Nowa Sól, Poland
Ps0014 374
Poznan, Poland
Ps0014 353
Szczecin, Poland
Ps0014 350
Warsaw, Poland
Ps0014 351
Warsaw, Poland
Ps0014 354
Warsaw, Poland
Ps0014 365
Wroclaw, Poland
Ps0014 367
Wroclaw, Poland
Ps0014 368
Wroclaw, Poland
Ps0014 370
Wroclaw, Poland
Ps0014 373
Wroclaw, Poland
Ps0014 400
Moscow, Russia
Ps0014 402
Moscow, Russia
Ps0014 403
Moscow, Russia
Ps0014 404
Saint Petersburg, Russia
Ps0014 405
Saint Petersburg, Russia
Ps0014 401
Saratov, Russia
Ps0014 406
Yaroslavl, Russia
Ps0014 701
Busan, South Korea
Ps0014 702
Gwangju, South Korea
Ps0014 705
Seongnam-si, South Korea
Ps0014 700
Seoul, South Korea
Ps0014 703
Seoul, South Korea
Ps0014 754
Taipei, Taiwan
Ps0014 755
Taipei, Taiwan
Ps0014 551
Dundee, United Kingdom
Ps0014 552
Liverpool, United Kingdom
Ps0014 550
Manchester, United Kingdom
Ps0014 554
Reading, United Kingdom
Ps0014 555
Salford, United Kingdom
Related Publications (12)
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: 35544084RESULTThaci 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.
PMID: 36689515RESULTGordon 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.
PMID: 37950894RESULTLebwohl 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.
PMID: 38588819RESULTMerola 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.
PMID: 39578348RESULTOkubo Y, Tada Y, Takahashi H, Abe M, Yamanaka K, Tilt N, Cross N, Deherder D, Matano M, Nakagawa H. Efficacy and Safety of Bimekizumab in Japanese Patients with Generalised Pustular Psoriasis and Erythrodermic Psoriasis: 3-Year Results from BE BRIGHT, a Multicentre, Open-Label, Phase 3 Study. Dermatol Ther (Heidelb). 2025 Oct;15(10):2947-2966. doi: 10.1007/s13555-025-01509-9. Epub 2025 Aug 11.
PMID: 40788331RESULTStrober 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.
PMID: 41060492RESULTArmstrong 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). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8.
PMID: 41359217RESULTKrueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Apr;157(4):905-916. doi: 10.1016/j.jaci.2025.12.1013. Epub 2026 Jan 22.
PMID: 41580158RESULTGisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9.
PMID: 41800601RESULTMerola 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.
PMID: 40886218DERIVEDKokolakis 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.
PMID: 36751950DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2018
First Posted
July 26, 2018
Study Start
September 5, 2018
Primary Completion
November 14, 2023
Study Completion
November 14, 2023
Last Updated
April 15, 2026
Results First Posted
December 6, 2024
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.