A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: PS00092016-003425-42
• Study Type: interventional
• Target: 567
• Locations: 11 countries
• Sites: 105

Brief Summary

This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

Conditions

Moderate to Severe Chronic Plaque Psoriasis; Chronic Plaque Psoriasis; Psoriatic Arthritis

Keywords

Bimekizumab; PSO; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16

  The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

  Week 16

• Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16

  The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline at Week 16.

  Week 16

Secondary Outcomes (17)

• Percentage of Participants With a PASI100 Response at Week 16

  Week 16

• Percentage of Participants With an IGA 0 Response at Week 16

  Week 16

• Percentage of Participants With a PASI75 Response at Week 4

  Week 4

• Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16

  Week 16

• Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16

  Week 16

Study Arms (3)

Bimekizumab cohort

EXPERIMENTAL

Subjects will receive bimekizumab for 52 weeks.

Drug: Bimekizumab

Ustekinumab cohort

ACTIVE COMPARATOR

Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.

Drug: Ustekinumab; Other: Placebo

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.

Drug: Bimekizumab; Other: Placebo

Interventions

Bimekizumab DRUG

Bimekizumab will be provided at pre-specified time intervals.

Also known as: UCB4940

Bimekizumab cohort; Placebo

Ustekinumab DRUG

Ustekinumab will be provided as dose 1 for subjects weighing \<=100 kg and as dose 2 for subjects weighing \>100 kg at pre-specified time intervals.

Also known as: Stelara®

Ustekinumab cohort

Placebo OTHER

Subjects will receive Placebo at pre-specified time points.

Also known as: PBO

Placebo; Ustekinumab cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age
• Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
• Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
• Subject is a candidate for systemic PSO therapy and/or phototherapy
• Female subject of child bearing potential must be willing to use highly effective method of contraception

You may not qualify if:

• Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent 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
• Presence of active suicidal ideation or positive suicide behavior
• Presence of moderately severe major depression or severe major depression
• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (105)

Ps0009 946

Phoenix, Arizona, 85032, United States

Location

Ps0009 910

Bakersfield, California, 93309, United States

Location

Ps0009 919

San Diego, California, 92103, United States

Location

Ps0009 906

Boca Raton, Florida, 33486, United States

Location

Ps0009 909

Boynton Beach, Florida, 33437, United States

Location

Ps0009 912

Coral Gables, Florida, 33134, United States

Location

Ps0009 907

Miami, Florida, 33144, United States

Location

Ps0009 903

Ocala, Florida, 34471, United States

Location

Ps0009 921

Ormond Beach, Florida, 32174, United States

Location

Ps0009 918

Tampa, Florida, 33612, United States

Location

Ps0009 941

Alpharetta, Georgia, 30022, United States

Location

Ps0009 911

Plainfield, Indiana, 46168, United States

Location

Ps0009 900

West Des Moines, Iowa, 50265, United States

Location

Ps0009 905

Overland Park, Kansas, 66215, United States

Location

Ps0009 922

Baton Rouge, Louisiana, 70809, United States

Location

Ps0009 917

Troy, Michigan, 48084, United States

Location

Ps0009 915

St Louis, Missouri, 63117, United States

Location

Ps0009 958

Omaha, Nebraska, 68144, United States

Location

Ps0009 901

Portsmouth, New Hampshire, 03801, United States

Location

Ps0009 908

East Windsor, New Jersey, 08520, United States

Location

Ps0009 923

Albuquerque, New Mexico, 87106, United States

Location

Ps0009 913

New York, New York, 10029-65, United States

Location

Ps0009 920

Portland, Oregon, 97210, United States

Location

Ps0009 924

Houston, Texas, 77004, United States

Location

Ps0009 914

San Antonio, Texas, 78213, United States

Location

Ps0009 004

Fremantle, Australia

Location

Ps0009 005

Phillip, Australia

Location

Ps0009 002

Westmead, Australia

Location

Ps0009 009

Woolloongabba, Australia

Location

Ps0009 050

Brussels, Belgium

Location

Ps0009 052

Liège, Belgium

Location

Ps0009 051

Loverval, Belgium

Location

Ps0009 673

Halifax, Canada

Location

Ps0009 652

Oakville, Canada

Location

Ps0009 651

Richmond Hill, Canada

Location

Ps0009 650

Surrey, Canada

Location

Ps0009 653

Toronto, Canada

Location

Ps0009 657

Waterloo, Canada

Location

Ps0009 218

Bonn, Germany

Location

Ps0009 209

Darmstadt, Germany

Location

Ps0009 214

Erlangen, Germany

Location

Ps0009 208

Frankfurt am Main, Germany

Location

Ps0009 210

Friedrichshafen, Germany

Location

Ps0009 211

Hamburg, Germany

Location

Ps0009 212

Heidelberg, Germany

Location

Ps0009 213

Mahlow, Germany

Location

Ps0009 205

Osnabrück, Germany

Location

Ps0009 217

Schweinfurt, Germany

Location

Ps0009 254

Budapest, Hungary

Location

Ps0009 255

Budapest, Hungary

Location

Ps0009 253

Orosháza, Hungary

Location

Ps0009 259

Szekszárd, Hungary

Location

Ps0009 300

Roma, Italy

Location

Ps0009 303

Roma, Italy

Location

Ps0009 629

Asahikawa, Japan

Location

Ps0009 605

Bunkyō City, Japan

Location

Ps0009 607

Chiyoda City, Japan

Location

Ps0009 610

Chūōku, Japan

Location

Ps0009 601

Fukuoka, Japan

Location

Ps0009 619

Gifu, Japan

Location

Ps0009 620

Hamamatsu, Japan

Location

Ps0009 608

Itabashi-Ku, Japan

Location

Ps0009 627

Itabashi-Ku, Japan

Location

Ps0009 609

Kobe, Japan

Location

Ps0009 600

Kurume, Japan

Location

Ps0009 622

Matsumoto, Japan

Location

Ps0009 604

Minatoku, Japan

Location

Ps0009 623

Morioka, Japan

Location

Ps0009 621

Nagoya, Japan

Location

Ps0009 625

Nankoku, Japan

Location

Ps0009 624

Obihiro, Japan

Location

Ps0009 611

Osaka, Japan

Location

Ps0009 614

Osaka, Japan

Location

Ps0009 603

Sapporo, Japan

Location

Ps0009 617

Sendai, Japan

Location

Ps0009 613

Shimotsuke, Japan

Location

Ps0009 602

Shinagawa-Ku, Japan

Location

Ps0009 612

Shinjuku-Ku, Japan

Location

Ps0009 618

Shinjuku-Ku, Japan

Location

Ps0009 626

Shinjuku-Ku, Japan

Location

Ps0009 628

Shinjuku-Ku, Japan

Location

Ps0009 615

Sumida City, Japan

Location

Ps0009 606

Takaoka, Japan

Location

Ps0009 616

Tsu, Japan

Location

Ps0009 362

Bialystok, Poland

Location

Ps0009 369

Bialystok, Poland

Location

Ps0009 371

Bydgoszcz, Poland

Location

Ps0009 358

Katowice, Poland

Location

Ps0009 357

Kielce, Poland

Location

Ps0009 372

Lodz, Poland

Location

Ps0009 374

Poznan, Poland

Location

Ps0009 350

Warsaw, Poland

Location

Ps0009 351

Warsaw, Poland

Location

Ps0009 367

Wroclaw, Poland

Location

Ps0009 370

Wroclaw, Poland

Location

Ps0009 400

Moscow, Russia

Location

Ps0009 402

Moscow, Russia

Location

Ps0009 403

Moscow, Russia

Location

Ps0009 404

Saint Petersburg, Russia

Location

Ps0009 556

Cardiff, United Kingdom

Location

Ps0009 551

Dundee, United Kingdom

Location

Ps0009 553

Edgbaston, United Kingdom

Location

Ps0009 552

Liverpool, United Kingdom

Location

Ps0009 550

Manchester, United Kingdom

Location

Ps0009 555

Salford, United Kingdom

Location

Related Publications (12)

• Asahina A, Okubo Y, Morita A, Tada Y, Igarashi A, Langley RG, Deherder D, Matano M, Vanvoorden V, Wang M, Ohtsuki M, Nakagawa H. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.

  PMID: 36648594 RESULT

• 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: 35544084 RESULT

• 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.

  PMID: 37950894 RESULT

• 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.

  PMID: 41060492 RESULT

• 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.

  PMID: 41359217 RESULT

• 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.

  PMID: 41580158 RESULT

• 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.

  PMID: 41800601 RESULT

• 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.

  PMID: 40886218 DERIVED

• 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.

  PMID: 39578348 DERIVED

• 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.

  PMID: 36751950 DERIVED

• Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14.

  PMID: 34260044 DERIVED

• Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021 Feb 6;397(10273):487-498. doi: 10.1016/S0140-6736(21)00125-2.

  PMID: 33549193 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Interventions

bimekizumab; Ustekinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: December 6, 2017
• Primary Completion: January 8, 2019
• Study Completion: December 13, 2019
• Last Updated: April 15, 2026
• Results First Posted: February 3, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4); DE (10); GB (6); JP (30); US (25); BE (3); AU (4); CA (6); HU (4); IT (2); PL (11)