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Chronic Plaque PsoriasisPhase 3BE BRIGHTNCT03598790

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase 3 study testing Bimekizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 189 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bimekizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,353 participants
Where
189 sitesin 13 countries
Study dates
5 Sep 2018to 14 Nov 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

189 sites in 13 countries.

189 sites in 13 countries

United States48 sites

  • Ps0014 941

    Alpharetta, Georgia, 30022

  • Ps0014 910

    Bakersfield, California, 93309

  • Ps0014 922

    Baton Rouge, Louisiana, 70809

  • Ps0014 940

    Beverly, Massachusetts, 01915

  • Ps0014 909

    Boynton Beach, Florida, 33437

  • Ps0014 925

    Brighton, Massachusetts, 02135

  • Ps0014 947

    Buffalo, New York, 14221

  • Ps0014 915

    Clayton, Missouri, 63105

  • Ps0014 912

    Coral Gables, Florida, 33134

  • Ps0014 931

    Dallas, Texas, 75231

  • Ps0014 908

    East Windsor, New Jersey, 08520

  • Ps0014 928

    Fort Myers, Florida, 33912

  • Ps0014 957

    Glendale, Arizona, 85308

  • Ps0014 945

    Greer, South Carolina, 29650

  • Ps0014 906

    Hollywood, Florida, 33021

  • Ps0014 924

    Houston, Texas, 77004

  • Ps0014 937

    Johnston, Rhode Island, 02919

  • Ps0014 965

    Kew Gardens, New York, 11415

  • Ps0014 927

    Los Angeles, California, 90033

  • Ps0014 907

    Miami, Florida, 33144

  • Ps0014 933

    Murray, Utah, 84107

  • Ps0014 944

    New Orleans, Louisiana, 70115

  • Ps0014 913

    New York, New York, 10029-6501

  • Ps0014 903

    Ocala, Florida, 34470

  • Ps0014 932

    Oklahoma City, Oklahoma, 73112

  • Ps0014 958

    Omaha, Nebraska, 68144

  • Ps0014 921

    Ormond Beach, Florida, 32174

  • Ps0014 905

    Overland Park, Kansas, 66210

  • Ps0014 962

    Owensboro, Kentucky, 42301

  • Ps0014 946

    Phoenix, Arizona, 85032

  • Ps0014 911

    Plainfield, Indiana, 46168

  • Ps0014 920

    Portland, Oregon, 97210

  • Ps0014 929

    Portland, Oregon, 97223

  • Ps0014 901

    Portsmouth, New Hampshire, 03801

  • Ps0014 963

    Rochester, New York, 14623

  • Ps0014 961

    Rocky Mount, North Carolina, 27804

  • Ps0014 914

    San Antonio, Texas, 78213

  • Ps0014 919

    San Diego, California, 92103

  • Ps0014 955

    San Diego, California, 92123

  • Ps0014 943

    San Luis Obispo, California, 93405

  • Ps0014 967

    Santa Monica, California, 90404

  • Ps0014 954

    Skokie, Illinois, 60077

  • Ps0014 936

    Tampa, Florida, 33613

  • Ps0014 917

    Troy, Michigan, 48084

  • Ps0014 956

    Verona, New Jersey, 07044

  • Ps0014 934

    Washington D.C., District of Columbia, 20016

  • Ps0014 951

    Webster, Texas, 77598

  • Ps0014 900

    West Des Moines, Iowa, 50265

Other trials in United States

Japan30 sites

  • Ps0014 629

    Asahikawa

  • Ps0014 605

    Bunkyō City

  • Ps0014 607

    Chiyoda-ku

  • Ps0014 610

    Chūōku

  • Ps0014 601

    Fukuoka

  • Ps0014 619

    Gifu

  • Ps0014 620

    Hamamatsu

  • Ps0014 609

    Kobe

  • Ps0014 600

    Kurume

  • Ps0014 622

    Matsumoto

  • Ps0014 604

    Minatoku

  • Ps0014 623

    Morioka

  • Ps0014 621

    Nagoya

  • Ps0014 625

    Nankoku

  • Ps0014 624

    Obihiro

  • Ps0014 611

    Osaka

  • Ps0014 614

    Osaka

  • Ps0014 603

    Sapporo

  • Ps0014 617

    Sendai

  • Ps0014 613

    Shimotsuke

  • Ps0014 602

    Shinagawa-ku

  • Ps0014 612

    Shinjuku-ku

  • Ps0014 618

    Shinjuku-ku

  • Ps0014 626

    Shinjuku-ku

  • Ps0014 628

    Shinjuku-ku

  • Ps0014 608

    tabashi City

  • Ps0014 606

    Takaoka

  • Ps0014 615

    Tokyo

  • Ps0014 627

    Tokyo

  • Ps0014 616

    Tsu

Other trials in Japan

Poland25 sites

  • Ps0014 355

    Bialystok

  • Ps0014 361

    Bialystok

  • Ps0014 362

    Bialystok

  • Ps0014 369

    Bialystok

  • Ps0014 371

    Bydgoszcz

  • Ps0014 352

    Gdansk

  • Ps0014 358

    Katowice

  • Ps0014 359

    Katowice

  • Ps0014 366

    Katowice

  • Ps0014 357

    Kielce

  • Ps0014 363

    Krakow

  • Ps0014 360

    Lodz

  • Ps0014 372

    Lodz

  • Ps0014 356

    Lublin

  • Ps0014 364

    Nowa Sól

  • Ps0014 374

    Poznan

  • Ps0014 353

    Szczecin

  • Ps0014 350

    Warsaw

  • Ps0014 351

    Warsaw

  • Ps0014 354

    Warsaw

  • Ps0014 365

    Wroclaw

  • Ps0014 367

    Wroclaw

  • Ps0014 368

    Wroclaw

  • Ps0014 370

    Wroclaw

  • Ps0014 373

    Wroclaw

Other trials in Poland

Canada23 sites

  • Ps0014 658

    Ajax

  • Ps0014 659

    Calgary

  • Ps0014 672

    Edmonton

  • Ps0014 673

    Halifax

  • Ps0014 671

    Hamilton

  • Ps0014 675

    Markham

  • Ps0014 663

    Mississauga

  • Ps0014 660

    Montreal

  • Ps0014 668

    North Bay

  • Ps0014 652

    Oakville

  • Ps0014 667

    Ottawa

  • Ps0014 661

    Peterborough

  • Ps0014 665

    Québec

  • Ps0014 651

    Richmond Hill

  • Ps0014 650

    Surrey

  • Ps0014 676

    Surrey

  • Ps0014 653

    Toronto

  • Ps0014 662

    Toronto

  • Ps0014 664

    Toronto

  • Ps0014 657

    Waterloo

  • Ps0014 669

    Windsor

  • Ps0014 670

    Windsor

  • Ps0014 674

    Winnipeg

Other trials in Canada

Germany18 sites

  • Ps0014 207

    Berlin

  • Ps0014 218

    Bonn

  • Ps0014 209

    Darmstadt

  • Ps0014 203

    Dresden

  • Ps0014 214

    Erlangen

  • Ps0014 208

    Frankfurt

  • Ps0014 210

    Friedrichshafen

  • Ps0014 202

    Hamburg

  • Ps0014 211

    Hamburg

  • Ps0014 220

    Hamburg

  • Ps0014 212

    Heidelberg

  • Ps0014 215

    Lübeck

  • Ps0014 213

    Mahlow

  • Ps0014 219

    Münster

  • Ps0014 205

    Osnabrück

  • Ps0014 217

    Schweinfurt

  • Ps0014 200

    Schwerin

  • Ps0014 204

    Witten

Other trials in Germany

Hungary12 sites

  • Ps0014 252

    Budapest

  • Ps0014 254

    Budapest

  • Ps0014 255

    Budapest

  • Ps0014 261

    Budapest

  • Ps0014 256

    Debrecen

  • Ps0014 262

    Encs

  • Ps0014 251

    Gyula

  • Ps0014 253

    Orosháza

  • Ps0014 260

    Szeged

  • Ps0014 259

    Szekszárd

  • Ps0014 250

    Szolnok

  • Ps0014 258

    Veszprém

Other trials in Hungary

Australia9 sites

  • PS0014 7

    Campbelltown

  • PS0014 3

    Carlton

  • PS0014 8

    East Melbourne

  • PS0014 4

    Fremantle

  • Ps0014 10

    Kogarah

  • PS0014 6

    Kogarah

  • PS0014 5

    Phillip

  • PS0014 2

    Westmead

  • PS0014 9

    Woolloongabba

Other trials in Australia

Russia7 sites

  • Ps0014 400

    Moscow

  • Ps0014 402

    Moscow

  • Ps0014 403

    Moscow

  • Ps0014 404

    Saint Petersburg

  • Ps0014 405

    Saint Petersburg

  • Ps0014 401

    Saratov

  • Ps0014 406

    Yaroslavl

Other trials in Russia

South Korea5 sites

  • Ps0014 701

    Busan

  • Ps0014 702

    Gwangju

  • Ps0014 705

    Seongnam-si

  • Ps0014 700

    Seoul

  • Ps0014 703

    Seoul

Other trials in South Korea

United Kingdom5 sites

  • Ps0014 551

    Dundee

  • Ps0014 552

    Liverpool

  • Ps0014 550

    Manchester

  • Ps0014 554

    Reading

  • Ps0014 555

    Salford

Other trials in United Kingdom

Belgium3 sites

  • Ps0014 50

    Brussels

  • Ps0014 51

    Charleroi

  • Ps0014 52

    Liège

Other trials in Belgium

Italy2 sites

  • Ps0014 300

    Roma

  • Ps0014 303

    Roma

Other trials in Italy

Taiwan2 sites

  • Ps0014 754

    Taipei

  • Ps0014 755

    Taipei

Other trials in Taiwan

About this study

Official title: 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).

Read the 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.

Being tested
Bimekizumab
Keywords
Bimekizumab, PSO, Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabDrug

    Also called UCB4940

    Subjects will receive bimekizumab at pre-specified time-points.

Study groups in NCT03598790
Study groupRoleWhat they receive
Bimekizumab dose regimen 1ExperimentalSubjects 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
Receives: Drug: Bimekizumab
Bimekizumab dose regimen 2ExperimentalSubjects 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
Receives: Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B

  4. 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.

    Measured: Week 144 compared to Baseline of PS0014 for Cohort B

  5. 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.

    Measured: Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B

  6. 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.

    Measured: Week 144 for Cohort B EP and GPP groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start5 Sep 2018
  3. Primary completion14 Nov 2023
  4. Study completion14 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03598790
Sponsor's protocol ID
PS0014
Other IDs
2016-003427-30, 2016
Acronym
BE BRIGHT
Status last verified
Apr 2026
First submitted
16 Jul 2018
Last updated
15 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 35544084

  • 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.

    PubMed 36689515

  • 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.

    PubMed 37950894

  • 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.

    PubMed 38588819

  • 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.

    PubMed 39578348

  • 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.

    PubMed 40788331

  • 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.

    PubMed 41060492

  • 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.

    PubMed 41359217

  • 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.

    PubMed 41580158

  • 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.

    PubMed 41800601

  • 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.

    PubMed 40886218

  • Blauvelt A, Langley RG, Lebwohl M, Strober B, Warren RB, Puig L, Morita A, Gordon KB, Fernandez-Penas P, Kavanagh S, Lopez Pinto JM, Lambert J, Hoepken B, Deherder D, Cross N, Thaci D. Bimekizumab durability of efficacy through 196 weeks and safety through 4 years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial. J Am Acad Dermatol. 2025 Sep;93(3):644-653. doi: 10.1016/j.jaad.2025.04.038. Epub 2025 Apr 24.

    PubMed 40286813

  • 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.

    PubMed 36751950

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 189 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Japan, Poland, Canada, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03598790, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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