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

NCT03536884 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: PS00152017-003784-35
• Study Type: interventional
• Target: 743
• Locations: 11 countries
• Sites: 77

Brief Summary

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

Conditions

Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis

Keywords

Bimekizumab; PSO; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16

  The PASI100 response assessments are based on 100% 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 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 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

Secondary Outcomes (7)

• Percentage of Participants With a PASI75 Response at Week 4

  Week 4

• Percentage of Participants With a PASI90 Response at Week 16

  Week 16

• Percentage of Participants With a PASI100 Response at Week 48

  Week 48

• Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16

  Week 16

• Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225

  From Baseline up to Week 225

Study Arms (3)

Bimekizumab dosage regimen 1

EXPERIMENTAL

Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1). At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2). Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Drug: Bimekizumab; Other: Placebo

Bimekizumab dosage regimen 2

EXPERIMENTAL

Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks. Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Drug: Bimekizumab; Other: Placebo

Secukinumab

ACTIVE COMPARATOR

Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2). Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Drug: Bimekizumab; Drug: Secukinumab

Interventions

Bimekizumab DRUG

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

Also known as: UCB4940

Bimekizumab dosage regimen 1; Bimekizumab dosage regimen 2; Secukinumab

Placebo OTHER

Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.

Also known as: PBO

Bimekizumab dosage regimen 1; Bimekizumab dosage regimen 2

Secukinumab DRUG

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

Also known as: COSENTYX®

Secukinumab

Eligibility Criteria

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

You may qualify if:

• Double-blind Treatment Period
• Male or female at least 18 years of age
• Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
• Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
• Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
• Female subject of childbearing potential must be willing to use highly effective method of contraception
• Open-label extension (OLE) Period
• Completed the double-blind Treatment Period without meeting any withdrawal criteria
• All Week 48 visit assessments completed
• Compliant with ongoing clinical study requirements
• Signed a separate OLE Period Informed Consent Form (ICF)
• Female subject of childbearing potential must be willing to use highly effective method of contraception
• OLE2 Period (USA and Canada)
• Completed the OLE Period without meeting any withdrawal criteria

You may not qualify if:

• Double-blind Treatment Period
• Subject has an active infection (except common cold), a 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 severe 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
• OLE2 Period (USA and Canada)
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (77)

Ps0015 975

Santa Ana, California, 92701, United States

Location

Ps0015 939

Danbury, Connecticut, 06810, United States

Location

Ps0015 903

Ocala, Florida, 34470, United States

Location

Ps0015 921

Ormond Beach, Florida, 32174, United States

Location

Ps0015 977

Pembroke Pines, Florida, 33028, United States

Location

Ps0015 936

Tampa, Florida, 33613, United States

Location

Ps0015 976

Tampa, Florida, 33614, United States

Location

Ps0015 970

West Palm Beach, Florida, 33409, United States

Location

Ps0015 966

Sandy Springs, Georgia, 30328, United States

Location

Ps0015 954

Skokie, Illinois, 60077, United States

Location

Ps0015 972

West Dundee, Illinois, 60118, United States

Location

Ps0015 900

West Des Moines, Iowa, 50265, United States

Location

Ps0015 944

New Orleans, Louisiana, 70115, United States

Location

Ps0015 915

Clayton, Missouri, 63105, United States

Location

Ps0015 953

St Louis, Missouri, 63141, United States

Location

Ps0015 901

Portsmouth, New Hampshire, 03801, United States

Location

Ps0015 965

Kew Gardens, New York, 11415, United States

Location

Ps0015 969

High Point, North Carolina, 27262, United States

Location

Ps0015 971

Wilmington, North Carolina, 28405, United States

Location

Ps0015 980

Bexley, Ohio, 43209, United States

Location

Ps0015 920

Portland, Oregon, 97210, United States

Location

Ps0015 929

Portland, Oregon, 97223, United States

Location

Ps0015 979

Dallas, Texas, 75246, United States

Location

Ps0015 924

Houston, Texas, 77004, United States

Location

Ps0015 978

Pflugerville, Texas, 78660, United States

Location

PS0015 3

Carlton, Australia

Location

PS0015 7

Hectorville, Australia

Location

PS0015 6

Kogarah, Australia

Location

Ps0015 11

Parkville, Australia

Location

PS0015 9

Woolloongabba, Australia

Location

Ps0015 50

Brussels, Belgium

Location

Ps0015 54

Brussels, Belgium

Location

Ps0015 52

Liège, Belgium

Location

Ps0015 673

Halifax, Canada

Location

Ps0015 671

Hamilton, Canada

Location

Ps0015 663

Mississauga, Canada

Location

Ps0015 661

Peterborough, Canada

Location

Ps0015 678

Richmond Hill, Canada

Location

Ps0015 677

Toronto, Canada

Location

Ps0015 657

Waterloo, Canada

Location

Ps0015 153

Toulouse, France

Location

Ps0015 223

Augsburg, Germany

Location

Ps0015 237

Berlin, Germany

Location

Ps0015 211

Hamburg, Germany

Location

Ps0015 215

Lübeck, Germany

Location

Ps0015 213

Mahlow, Germany

Location

Ps0015 238

Mainz, Germany

Location

Ps0015 234

München, Germany

Location

Ps0015 219

Münster, Germany

Location

Ps0015 236

Neu-Ulm, Germany

Location

Ps0015 222

Tübingen, Germany

Location

Ps0015 204

Witten, Germany

Location

Ps0015 265

Amsterdam, Netherlands

Location

Ps0015 263

Breda, Netherlands

Location

Ps0015 355

Bialystok, Poland

Location

Ps0015 361

Bialystok, Poland

Location

Ps0015 369

Bialystok, Poland

Location

Ps0015 352

Gdansk, Poland

Location

Ps0015 366

Katowice, Poland

Location

Ps0015 378

Katowice, Poland

Location

Ps0015 376

Krakow, Poland

Location

Ps0015 379

Krakow, Poland

Location

Ps0015 372

Lodz, Poland

Location

Ps0015 377

Ostrowiec Świętokrzyski, Poland

Location

Ps0015 368

Wroclaw, Poland

Location

Ps0015 375

Wroclaw, Poland

Location

Ps0015 455

Alicante, Spain

Location

Ps0015 450

Barcelona, Spain

Location

Ps0015 451

Madrid, Spain

Location

Ps0015 454

Madrid, Spain

Location

Ps0015 456

Madrid, Spain

Location

Ps0015 457

Sant Joan Despí, Spain

Location

Ps0015 763

Gaziantep, Turkey (Türkiye)

Location

Ps0015 762

Istanbul, Turkey (Türkiye)

Location

Ps0015 760

Kayseri, Turkey (Türkiye)

Location

Ps0015 559

Newcastle upon Tyne, United Kingdom

Location

Ps0015 555

Salford, United Kingdom

Location

Related Publications (13)

• Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.

  PMID: 37182701 RESULT

• 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.

  PMID: 38588819 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 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

• 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

• Augustin M, Feldman SR, Warren RB, Armstrong A, Vender R, Lopez-Ferrer A, Dawe WH, Lambert J, Szilagyi B, Hoepken B, Warham R, Gottlieb AB. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. 2026 Feb 18:e256055. doi: 10.1001/jamadermatol.2025.6055. Online ahead of print.

  PMID: 41706476 DERIVED

• 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

• Warren RB, Lebwohl M, Thaci D, Gooderham M, Pinter A, Paul C, Gisondi P, Szilagyi B, White K, Deherder D, Staelens F, Lambert J, Strober B. Bimekizumab efficacy and safety through 3 years in patients with moderate-to-severe plaque psoriasis: long-term results from the BE RADIANT phase IIIb trial open-label extension period. Br J Dermatol. 2025 Jun 20;193(1):44-55. doi: 10.1093/bjd/ljaf032.

  PMID: 39862230 DERIVED

• Augustin M, Gottlieb AB, Lebwohl M, Pinter A, Warren RB, Puig L, Warham R, Lambert J, Wiegratz S, Szilagyi B, Blauvelt A. Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2841-2857. doi: 10.1007/s13555-024-01261-6. Epub 2024 Sep 17.

  PMID: 39285121 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

• Gottlieb AB, Warren RB, Augustin M, 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 Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.

  PMID: 34471992 DERIVED

• Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.

  PMID: 34001692 DERIVED

• Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.

  PMID: 33891380 DERIVED

Related Links

• FDA Safety Alerts and Recalls
• Product Information

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab; secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  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: May 14, 2018
• First Posted: May 25, 2018
• Study Start: June 13, 2018
• Primary Completion: September 12, 2019
• Study Completion: August 9, 2023
• Last Updated: April 15, 2026
• Results First Posted: October 10, 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

DE (11); BE (3); NL (2); PL (12); GB (2); ES (6); FR (1); US (25); AU (5); CA (7); TU (3)