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

NCT03412747 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: PS00082016-003392-22
• Study Type: interventional
• Target: 478
• Locations: 9 countries
• Sites: 77

Brief Summary

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

Conditions

Chronic Plaque Psoriasis; Moderate to Severe Plaque Psoriasis

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 PASI score from 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 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 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 16

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

  The 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 (13)

• Percentage of Participants With a PASI90 Response at Week 24

  Week 24

• Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24

  Week 24

• Percentage of Participants With a PASI75 Response at Week 4

  Week 4

• Percentage of Participants With a PASI100 Response at Week 16

  Week 16

• Percentage of Participants With a PASI100 Response at Week 24

  Week 24

Study Arms (3)

Bimekizumab Arm 1

EXPERIMENTAL

Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Drug: Bimekizumab; Other: Placebo

Bimekizumab Arm 2

EXPERIMENTAL

Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Drug: Bimekizumab; Other: Placebo

Adalimumab Arm

ACTIVE COMPARATOR

Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Drug: Bimekizumab; Drug: Adalimumab; Other: Placebo

Interventions

Bimekizumab DRUG

Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

Also known as: UCB4940

Adalimumab Arm; Bimekizumab Arm 1; Bimekizumab Arm 2

Adalimumab DRUG

Adalimumab will be administered according to the labeling recommendations.

Also known as: Humira®

Adalimumab Arm

Placebo OTHER

Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).

Also known as: PBO

Adalimumab Arm; Bimekizumab Arm 1; Bimekizumab Arm 2

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 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 a known hypersensitivity to any excipients of bimekizumab or adalimumab
• Subject has an active infection (except common cold), a 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
• Subject has had previous exposure to adalimumab
• 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 (77)

Ps0008 957

Glendale, Arizona, 85308, United States

Location

Ps0008 927

Los Angeles, California, 90033, United States

Location

Ps0008 955

San Diego, California, 92123, United States

Location

Ps0008 943

San Luis Obispo, California, 93405, United States

Location

Ps0008 967

Santa Monica, California, 90404, United States

Location

Ps0008 939

Danbury, Connecticut, 06810, United States

Location

Ps0008 934

Washington D.C., District of Columbia, 20037, United States

Location

Ps0008 906

Boca Raton, Florida, 33486, United States

Location

Ps0008 936

Tampa, Florida, 33624, United States

Location

Ps0008 900

West Des Moines, Iowa, 50265, United States

Location

Ps0008 905

Overland Park, Kansas, 66215, United States

Location

Ps0008 940

Beverly, Massachusetts, 01844, United States

Location

Ps0008 925

Brighton, Massachusetts, 02135, United States

Location

Ps0008 917

Troy, Michigan, 48084, United States

Location

Ps0008 908

East Windsor, New Jersey, 08520, United States

Location

Ps0008 961

Rocky Mount, North Carolina, 27804, United States

Location

Ps0008 935

Winston-Salem, North Carolina, 27104-35 20, United States

Location

Ps0008 932

Oklahoma City, Oklahoma, 73112, United States

Location

Ps0008 929

Portland, Oregon, 97223, United States

Location

Ps0008 945

Greer, South Carolina, 29650, United States

Location

Ps0008 931

Dallas, Texas, 75231, United States

Location

Ps0008 924

Houston, Texas, 77004, United States

Location

Ps0008 951

Houston, Texas, 77004, United States

Location

Ps0008 008

East Melbourne, Australia

Location

Ps0008 004

Fremantle, Australia

Location

Ps0008 007

Hectorville, Australia

Location

Ps0008 010

Kogarah, Australia

Location

Ps0008 005

Phillip, Australia

Location

Ps0008 009

Woolloongabba, Australia

Location

Ps0008 659

Calgary, Canada

Location

Ps0008 663

Mississauga, Canada

Location

Ps0008 660

Montreal, Canada

Location

Ps0008 661

Peterborough, Canada

Location

Ps0008 662

Toronto, Canada

Location

Ps0008 664

Toronto, Canada

Location

Ps0008 657

Waterloo, Canada

Location

Ps0008 669

Windsor, Canada

Location

Ps0008 670

Windsor, Canada

Location

Ps0008 674

Winnipeg, Canada

Location

Ps0008 207

Berlin, Germany

Location

Ps0008 218

Bonn, Germany

Location

Ps0008 203

Dresden, Germany

Location

Ps0008 211

Hamburg, Germany

Location

Ps0008 220

Hamburg, Germany

Location

Ps0008 215

Lübeck, Germany

Location

Ps0008 213

Mahlow, Germany

Location

Ps0008 205

Osnabrück, Germany

Location

Ps0008 217

Schweinfurt, Germany

Location

Ps0008 252

Budapest, Hungary

Location

Ps0008 254

Budapest, Hungary

Location

Ps0008 255

Budapest, Hungary

Location

Ps0008 256

Debrecen, Hungary

Location

Ps0008 251

Gyula, Hungary

Location

Ps0008 260

Szeged, Hungary

Location

Ps0008 355

Bialystok, Poland

Location

Ps0008 362

Bialystok, Poland

Location

Ps0008 371

Bydgoszcz, Poland

Location

Ps0008 352

Gdansk, Poland

Location

Ps0008 359

Katowice, Poland

Location

Ps0008 366

Katowice, Poland

Location

Ps0008 363

Krakow, Poland

Location

Ps0008 360

Lodz, Poland

Location

Ps0008 372

Lodz, Poland

Location

Ps0008 356

Lublin, Poland

Location

Ps0008 364

Nowa Sól, Poland

Location

Ps0008 353

Szczecin, Poland

Location

Ps0008 354

Warsaw, Poland

Location

Ps0008 365

Wroclaw, Poland

Location

Ps0008 367

Wroclaw, Poland

Location

Ps0008 373

Wroclaw, Poland

Location

Ps0008 405

Saint Petersburg, Russia

Location

Ps0008 401

Saratov, Russia

Location

Ps0008 406

Yaroslavl, Russia

Location

Ps0008 702

Gwangju, South Korea

Location

Ps0008 700

Seoul, South Korea

Location

Ps0008 754

Taipei, Taiwan

Location

Ps0008 755

Taipei, Taiwan

Location

Related Publications (11)

• 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.

  PMID: 36689515 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, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):130-141. doi: 10.1056/NEJMoa2102388. Epub 2021 Apr 23.

  PMID: 33891379 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab; Adalimumab

Condition Hierarchy (Ancestors)

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

001 844 599 2273

Study Officials

• UCB Cares

  +1 844 599 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: January 22, 2018
• First Posted: January 26, 2018
• Study Start: January 26, 2018
• Primary Completion: February 7, 2019
• Study Completion: February 26, 2020
• Last Updated: April 15, 2026
• Results First Posted: March 2, 2022

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.

Locations

US (23); KR (2); CA (10); AU (6); DE (9); PL (16); TW (2); RU (3); HU (6)