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

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).

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Chronic Plaque Psoriasis; Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Bimekizumab

Detailed Description

The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.

• Study Type: Interventional
• Enrollment (Actual): 1353
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Campbelltown, Australia
    • PS0014 7
  • Carlton, Australia
    • PS0014 3
  • East Melbourne, Australia
    • PS0014 8
  • Fremantle, Australia
    • PS0014 4
  • Kogarah, Australia
    • Ps0014 10
  • Kogarah, Australia
    • PS0014 6
  • Phillip, Australia
    • PS0014 5
  • Westmead, Australia
    • PS0014 2
  • Woolloongabba, Australia
    • PS0014 9
• Belgium
  • Brussels, Belgium
    • Ps0014 50
  • Charleroi, Belgium
    • Ps0014 51
  • Liège, Belgium
    • Ps0014 52
• Canada
  • Ajax, Canada
    • Ps0014 658
  • Calgary, Canada
    • Ps0014 659
  • Edmonton, Canada
    • Ps0014 672
  • Halifax, Canada
    • Ps0014 673
  • Hamilton, Canada
    • Ps0014 671
  • Markham, Canada
    • Ps0014 675
  • Mississauga, Canada
    • Ps0014 663
  • Montreal, Canada
    • Ps0014 660
  • North Bay, Canada
    • Ps0014 668
  • Oakville, Canada
    • Ps0014 652
  • Ottawa, Canada
    • Ps0014 667
  • Peterborough, Canada
    • Ps0014 661
  • Québec, Canada
    • Ps0014 665
  • Richmond Hill, Canada
    • Ps0014 651
  • Surrey, Canada
    • Ps0014 650
  • Surrey, Canada
    • Ps0014 676
  • Toronto, Canada
    • Ps0014 653
  • Toronto, Canada
    • Ps0014 662
  • Toronto, Canada
    • Ps0014 664
  • Waterloo, Canada
    • Ps0014 657
  • Windsor, Canada
    • Ps0014 669
  • Windsor, Canada
    • Ps0014 670
  • Winnipeg, Canada
    • Ps0014 674
• Germany
  • Berlin, Germany
    • Ps0014 207
  • Bonn, Germany
    • Ps0014 218
  • Darmstadt, Germany
    • Ps0014 209
  • Dresden, Germany
    • Ps0014 203
  • Erlangen, Germany
    • Ps0014 214
  • Frankfurt, Germany
    • Ps0014 208
  • Friedrichshafen, Germany
    • Ps0014 210
  • Hamburg, Germany
    • Ps0014 202
  • Hamburg, Germany
    • Ps0014 211
  • Hamburg, Germany
    • Ps0014 220
  • Heidelberg, Germany
    • Ps0014 212
  • Lübeck, Germany
    • Ps0014 215
  • Mahlow, Germany
    • Ps0014 213
  • Münster, Germany
    • Ps0014 219
  • Osnabrück, Germany
    • Ps0014 205
  • Schweinfurt, Germany
    • Ps0014 217
  • Schwerin, Germany
    • Ps0014 200
  • Witten, Germany
    • Ps0014 204
• Hungary
  • Budapest, Hungary
    • Ps0014 252
  • Budapest, Hungary
    • Ps0014 254
  • Budapest, Hungary
    • Ps0014 255
  • Budapest, Hungary
    • Ps0014 261
  • Debrecen, Hungary
    • Ps0014 256
  • Encs, Hungary
    • Ps0014 262
  • Gyula, Hungary
    • Ps0014 251
  • Orosháza, Hungary
    • Ps0014 253
  • Szeged, Hungary
    • Ps0014 260
  • Szekszárd, Hungary
    • Ps0014 259
  • Szolnok, Hungary
    • Ps0014 250
  • Veszprém, Hungary
    • Ps0014 258
• Italy
  • Roma, Italy
    • Ps0014 300
  • Roma, Italy
    • Ps0014 303
• Japan
  • Asahikawa, Japan
    • Ps0014 629
  • Bunkyō City, Japan
    • Ps0014 605
  • Chiyoda-ku, Japan
    • Ps0014 607
  • Chūōku, Japan
    • Ps0014 610
  • Fukuoka, Japan
    • Ps0014 601
  • Gifu, Japan
    • Ps0014 619
  • Hamamatsu, Japan
    • Ps0014 620
  • Itabashi-ku, Japan
    • Ps0014 608
  • Kobe, Japan
    • Ps0014 609
  • Kurume, Japan
    • Ps0014 600
  • Matsumoto, Japan
    • Ps0014 622
  • Minatoku, Japan
    • Ps0014 604
  • Morioka, Japan
    • Ps0014 623
  • Nagoya, Japan
    • Ps0014 621
  • Nankoku, Japan
    • Ps0014 625
  • Obihiro, Japan
    • Ps0014 624
  • Osaka, Japan
    • Ps0014 611
  • Osaka, Japan
    • Ps0014 614
  • Sapporo, Japan
    • Ps0014 603
  • Sendai, Japan
    • Ps0014 617
  • Shimotsuke, Japan
    • Ps0014 613
  • Shinagawa-ku, Japan
    • Ps0014 602
  • Shinjuku-ku, Japan
    • Ps0014 612
  • Shinjuku-ku, Japan
    • Ps0014 618
  • Shinjuku-ku, Japan
    • Ps0014 626
  • Shinjuku-ku, Japan
    • Ps0014 628
  • Takaoka, Japan
    • Ps0014 606
  • Tokyo, Japan
    • Ps0014 615
  • Tokyo, Japan
    • Ps0014 627
  • Tsu, Japan
    • Ps0014 616
• Poland
  • Bialystok, Poland
    • Ps0014 355
  • Bialystok, Poland
    • Ps0014 361
  • Bialystok, Poland
    • Ps0014 362
  • Bialystok, Poland
    • Ps0014 369
  • Bydgoszcz, Poland
    • Ps0014 371
  • Gdansk, Poland
    • Ps0014 352
  • Katowice, Poland
    • Ps0014 358
  • Katowice, Poland
    • Ps0014 359
  • Katowice, Poland
    • Ps0014 366
  • Kielce, Poland
    • Ps0014 357
  • Krakow, Poland
    • Ps0014 363
  • Lodz, Poland
    • Ps0014 360
  • Lodz, Poland
    • Ps0014 372
  • Lublin, Poland
    • Ps0014 356
  • Nowa Sól, Poland
    • Ps0014 364
  • Poznan, Poland
    • Ps0014 374
  • Szczecin, Poland
    • Ps0014 353
  • Warsaw, Poland
    • Ps0014 350
  • Warsaw, Poland
    • Ps0014 351
  • Warsaw, Poland
    • Ps0014 354
  • Wroclaw, Poland
    • Ps0014 365
  • Wroclaw, Poland
    • Ps0014 367
  • Wroclaw, Poland
    • Ps0014 368
  • Wroclaw, Poland
    • Ps0014 370
  • Wroclaw, Poland
    • Ps0014 373
• Russia
  • Moscow, Russia
    • Ps0014 400
  • Moscow, Russia
    • Ps0014 402
  • Moscow, Russia
    • Ps0014 403
  • Saint Petersburg, Russia
    • Ps0014 404
  • Saint Petersburg, Russia
    • Ps0014 405
  • Saratov, Russia
    • Ps0014 401
  • Yaroslavl, Russia
    • Ps0014 406
• South Korea
  • Busan, South Korea
    • Ps0014 701
  • Gwangju, South Korea
    • Ps0014 702
  • Seongnam-si, South Korea
    • Ps0014 705
  • Seoul, South Korea
    • Ps0014 700
  • Seoul, South Korea
    • Ps0014 703
• Taiwan
  • Taipei, Taiwan
    • Ps0014 754
  • Taipei, Taiwan
    • Ps0014 755
• United Kingdom
  • Dundee, United Kingdom
    • Ps0014 551
  • Liverpool, United Kingdom
    • Ps0014 552
  • Manchester, United Kingdom
    • Ps0014 550
  • Reading, United Kingdom
    • Ps0014 554
  • Salford, United Kingdom
    • Ps0014 555
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Ps0014 957
    • Phoenix, Arizona, United States, 85032
      • Ps0014 946
  • California
    • Bakersfield, California, United States, 93309
      • Ps0014 910
    • Los Angeles, California, United States, 90033
      • Ps0014 927
    • San Diego, California, United States, 92103
      • Ps0014 919
    • San Diego, California, United States, 92123
      • Ps0014 955
    • San Luis Obispo, California, United States, 93405
      • Ps0014 943
    • Santa Monica, California, United States, 90404
      • Ps0014 967
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Ps0014 934
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Ps0014 909
    • Coral Gables, Florida, United States, 33134
      • Ps0014 912
    • Fort Myers, Florida, United States, 33912
      • Ps0014 928
    • Hollywood, Florida, United States, 33021
      • Ps0014 906
    • Miami, Florida, United States, 33144
      • Ps0014 907
    • Ocala, Florida, United States, 34470
      • Ps0014 903
    • Ormond Beach, Florida, United States, 32174
      • Ps0014 921
    • Tampa, Florida, United States, 33613
      • Ps0014 936
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Ps0014 941
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Ps0014 954
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Ps0014 911
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Ps0014 900
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Ps0014 905
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Ps0014 962
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Ps0014 922
    • New Orleans, Louisiana, United States, 70115
      • Ps0014 944
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Ps0014 940
    • Brighton, Massachusetts, United States, 02135
      • Ps0014 925
  • Michigan
    • Troy, Michigan, United States, 48084
      • Ps0014 917
  • Missouri
    • Clayton, Missouri, United States, 63105
      • Ps0014 915
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Ps0014 958
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Ps0014 901
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Ps0014 908
    • Verona, New Jersey, United States, 07044
      • Ps0014 956
  • New York
    • Buffalo, New York, United States, 14221
      • Ps0014 947
    • Kew Gardens, New York, United States, 11415
      • Ps0014 965
    • New York, New York, United States, 10029-6501
      • Ps0014 913
    • Rochester, New York, United States, 14623
      • Ps0014 963
  • North Carolina
    • Rocky Mount, North Carolina, United States, 27804
      • Ps0014 961
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Ps0014 932
  • Oregon
    • Portland, Oregon, United States, 97210
      • Ps0014 920
    • Portland, Oregon, United States, 97223
      • Ps0014 929
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Ps0014 937
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Ps0014 945
  • Texas
    • Dallas, Texas, United States, 75231
      • Ps0014 931
    • Houston, Texas, United States, 77004
      • Ps0014 924
    • San Antonio, Texas, United States, 78213
      • Ps0014 914
    • Webster, Texas, United States, 77598
      • Ps0014 951
  • Utah
    • Murray, Utah, United States, 84107
      • Ps0014 933

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

  1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
  2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
  3. 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

Exclusion Criteria:

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimekizumab dose regimen 1; Subjects 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	Drug: Bimekizumab; Subjects will receive bimekizumab at pre-specified time-points.; Other Names: UCB4940
Experimental: Bimekizumab dose regimen 2; Subjects 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	Drug: Bimekizumab; Subjects will receive bimekizumab at pre-specified time-points.; Other Names: UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP	The number of SAEs 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 the first occurrence of the AE being considered. If a participant had no events, the total time at risk is 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
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP	The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the 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
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)	The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	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)	PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease.	Week 144 compared to Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)	The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear [0] or almost clear [1] with at least two category improvement from Baseline at visit timepoint.	Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)	The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144.	Week 144 for Cohort B EP and GPP groups

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Okubo 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.
• 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.
• 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). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8.
• Krueger 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.
• Gisondi 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Bimekizumab; PSO
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; bimekizumab
• Other Study ID Numbers: PS0014; 2016-003427-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No