A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03410992 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: PS00132016-003426-16
• Study Type: interventional
• Target: 435
• Locations: 9 countries
• Sites: 77

Brief Summary

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Conditions

Chronic Plaque Psoriasis; Moderate to Severe 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

  A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

  At Week 16

• Percentage of Participants With an Investigator's Global Assessment (IGA) 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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).

  At Week 16

Secondary Outcomes (17)

• Percentage of Participants With a PASI100 Response at Week 16

  At Week 16

• Percentage of Participants With a IGA Clear Response at Week 16

  At Week 16

• Percentage of Participants With a PASI75 Response at Week 4

  At Week 4

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

  At Week 16

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

  At Week 16

Study Arms (3)

Bimekizumab cohort

EXPERIMENTAL

Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.

Drug: Bimekizumab; Other: Placebo

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.

Other: Placebo

Bimekizumab Escape arm

EXPERIMENTAL

Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Bimekizumab will be provided at pre-specified time intervals.

Also known as: UCB4940

Bimekizumab Escape arm; Bimekizumab cohort

Placebo OTHER

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

Also known as: PBO

Bimekizumab cohort; Placebo

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, recurrent, or 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 (77)

Ps0013 919

San Diego, California, 92103, United States

Location

Ps0013 955

San Diego, California, 92123, United States

Location

Ps0013 967

Santa Monica, California, 90404, United States

Location

Ps0013 928

Fort Myers, Florida, 33912, United States

Location

Ps0013 966

Sandy Springs, Georgia, 30329, United States

Location

Ps0013 954

Skokie, Illinois, 60077, United States

Location

Ps0013 962

Owensboro, Kentucky, 42303, United States

Location

Ps0013 944

New Orleans, Louisiana, 70115, United States

Location

Ps0013 940

Beverly, Massachusetts, 01915, United States

Location

Ps0013 901

Portsmouth, New Hampshire, 03801, United States

Location

Ps0013 956

Verona, New Jersey, 07044-2946, United States

Location

Ps0013 947

Buffalo, New York, 14221, United States

Location

Ps0013 968

New York, New York, 10021, United States

Location

Ps0013 965

New York, New York, 10025, United States

Location

Ps0013 963

Rochester, New York, 14623, United States

Location

Ps0013 949

Cleveland, Ohio, 44106-1716, United States

Location

Ps0013 929

Portland, Oregon, 97223, United States

Location

Ps0013 937

Johnston, Rhode Island, 02919, United States

Location

Ps0013 914

San Antonio, Texas, 78213, United States

Location

Ps0013 933

Murray, Utah, 84107, United States

Location

Ps0013 003

Carlton, Australia

Location

Ps0013 008

East Melbourne, Australia

Location

Ps0013 006

Kogarah, Australia

Location

Ps0013 658

Ajax, Canada

Location

Ps0013 672

Edmonton, Canada

Location

Ps0013 671

Hamilton, Canada

Location

Ps0013 675

Markham, Canada

Location

Ps0013 663

Mississauga, Canada

Location

Ps0013 660

Montreal, Canada

Location

Ps0013 668

North Bay, Canada

Location

Ps0013 667

Ottawa, Canada

Location

Ps0013 665

Québec, Canada

Location

Ps0013 676

Surrey, Canada

Location

Ps0013 657

Waterloo, Canada

Location

Ps0013 202

Hamburg, Germany

Location

Ps0013 220

Hamburg, Germany

Location

Ps0013 219

Münster, Germany

Location

Ps0013 200

Schwerin, Germany

Location

Ps0013 204

Witten, Germany

Location

Ps0013 261

Budapest, Hungary

Location

Ps0013 262

Miskolc, Hungary

Location

Ps0013 253

Orosháza, Hungary

Location

Ps0013 260

Szeged, Hungary

Location

Ps0013 250

Szolnok, Hungary

Location

Ps0013 258

Veszprém, Hungary

Location

Ps0013 355

Bialystok, Poland

Location

Ps0013 361

Bialystok, Poland

Location

Ps0013 369

Bialystok, Poland

Location

Ps0013 352

Gdansk, Poland

Location

Ps0013 358

Katowice, Poland

Location

Ps0013 359

Katowice, Poland

Location

Ps0013 366

Katowice, Poland

Location

Ps0013 357

Kielce, Poland

Location

Ps0013 363

Krakow, Poland

Location

Ps0013 360

Lodz, Poland

Location

Ps0013 356

Lublin, Poland

Location

Ps0013 374

Poznan, Poland

Location

Ps0013 353

Szczecin, Poland

Location

Ps0013 350

Warsaw, Poland

Location

Ps0013 351

Warsaw, Poland

Location

Ps0013 354

Warsaw, Poland

Location

Ps0013 365

Wroclaw, Poland

Location

Ps0013 368

Wroclaw, Poland

Location

Ps0013 370

Wroclaw, Poland

Location

Ps0013 400

Moscow, Russia

Location

Ps0013 402

Moscow, Russia

Location

Ps0013 403

Moscow, Russia

Location

Ps0013 404

Saint Petersburg, Russia

Location

Ps0013 405

Saint Petersburg, Russia

Location

Ps0013 401

Saratov, Russia

Location

Ps0013 406

Yaroslavl, Russia

Location

Ps0013 701

Busan, South Korea

Location

Ps0013 705

Seongnam-si, South Korea

Location

Ps0013 703

Seoul, South Korea

Location

Ps0013 550

Manchester, United Kingdom

Location

Ps0013 554

Reading, United Kingdom

Location

Ps0013 555

Salford, United Kingdom

Location

Related Publications (9)

• 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, 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

• 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

• Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4.

  PMID: 33549192 DERIVED

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Interventions

bimekizumab

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

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: January 19, 2018
• First Posted: January 25, 2018
• Study Start: February 5, 2018
• Primary Completion: December 28, 2018
• Study Completion: January 7, 2020
• Last Updated: April 15, 2026
• Results First Posted: March 4, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (7); CA (11); DE (5); KR (3); PL (19); US (20); GB (3); AU (3); HU (6)