A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

NCT03896581 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: PA00112017-002804-29
• Study Type: interventional
• Target: 400
• Locations: 11 countries
• Sites: 92

Brief Summary

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; PsA; Bimekizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With American College of Rheumatology 50 (ACR50) Response

  The ACR50 response rate was based on a 50% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1.≥ 50% improvement in 68-tender joint count; 2.≥ 50% improvement in 66-swollen joint count; and 3.≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity \[100 mm visual analog scale (VAS) (0=no symptoms;100=severe symptoms)\], Patient global assessment of disease activity \[100 mm VAS (0=no limitation of normal activities;100=very poor\], Patient assessment of pain \[100 mm VAS (0=no pain;100=most severe pain)\], Health Assessment Questionnaire - Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).

  From Baseline to Week 16

Secondary Outcomes (14)

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16

  Baseline and Week 16

• Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline

  From Baseline to Week 4

• Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline

  From Baseline to Week 16

• Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16

  Baseline and Week 16

• Minimal Disease Activity (MDA) at Week 16

  Week 16

Study Arms (2)

Bimekizumab dosage regimen

EXPERIMENTAL

Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.

Drug: Bimekizumab

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive placebo.

Other: Placebo

Interventions

Bimekizumab DRUG

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

Also known as: BKZ, UCB4940

Bimekizumab dosage regimen

Placebo OTHER

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

Also known as: PBO

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is male or female at least 18 years of age
• Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
• Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) \>=3 out of 68 and swollen joint count (SJC) \>=3 out of 66
• Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
• Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
• Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
• Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

You may not qualify if:

• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
• Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
• Subject has an active infection or a history of recent serious infections
• 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 a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
• Subject had acute anterior uveitis within 6 weeks of Baseline
• 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
• Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
• Presence of active suicidal ideation, or moderately severe major depression or severe major depression
• Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (92)

Pa0011 50017

Phoenix, Arizona, 85037, United States

Location

Pa0011 50035

San Diego, California, 92128, United States

Location

Pa0011 50004

Tustin, California, 92780, United States

Location

Pa0011 50033

Palm Harbor, Florida, 34684, United States

Location

Pa0011 50037

Tampa, Florida, 33613, United States

Location

Pa0011 50039

Atlanta, Georgia, 30342, United States

Location

Pa0011 50024

Boise, Idaho, 83702, United States

Location

Pa0011 50028

Lexington, Kentucky, 40504, United States

Location

Pa0011 50023

Baton Rouge, Louisiana, 70836, United States

Location

Pa0011 50015

Hagerstown, Maryland, 21740, United States

Location

Pa0011 50026

Wheaton, Maryland, 20902, United States

Location

Pa0011 50047

Boston, Massachusetts, 02115-5817, United States

Location

Pa0011 50019

Lansing, Michigan, 48911, United States

Location

Pa0011 50016

St Louis, Missouri, 63141, United States

Location

Pa0011 50005

Freehold, New Jersey, 07728, United States

Location

Pa0011 50029

Albuquerque, New Mexico, 87102, United States

Location

Pa0011 50010

Brooklyn, New York, 11201, United States

Location

Pa0011 50011

New York, New York, 10003, United States

Location

Pa0011 50034

Rochester, New York, 14642, United States

Location

Pa0011 50125

Charlotte, North Carolina, 28210, United States

Location

Pa0011 50031

Salisbury, North Carolina, 28144, United States

Location

Pa0011 50040

Vandalia, Ohio, 45377, United States

Location

Pa0011 50020

Duncansville, Pennsylvania, 16635, United States

Location

Pa0011 50064

Philadelphia, Pennsylvania, 19104, United States

Location

Pa0011 50006

Wyomissing, Pennsylvania, 19610, United States

Location

Pa0011 50008

Johnston, Rhode Island, 02919, United States

Location

Pa0011 50021

Summerville, South Carolina, 29486, United States

Location

Pa0011 50001

Jackson, Tennessee, 38305, United States

Location

Pa0011 50012

Memphis, Tennessee, 38119-5214, United States

Location

Pa0011 50002

Austin, Texas, 78731, United States

Location

Pa0011 50036

Mesquite, Texas, 75150, United States

Location

Pa0011 50009

Waco, Texas, 76710, United States

Location

Pa0011 50050

Beckley, West Virginia, 25801, United States

Location

Pa0011 30005

Camberwell, Australia

Location

Pa0011 30007

Victoria Park, Australia

Location

Pa0011 30006

Woodville South, Australia

Location

Pa0011 50042

Rimouski, Canada

Location

Pa0011 50043

Sydney, Canada

Location

Pa0011 50044

Trois-Rivières, Canada

Location

Pa0011 40009

Pardubice, Czechia

Location

Pa0011 40063

Prague, Czechia

Location

Pa0011 40066

Prague, Czechia

Location

Pa0011 40012

Zlín, Czechia

Location

Pa0011 40076

Cottbus, Germany

Location

Pa0011 40023

Erlangen, Germany

Location

Pa0011 40117

Frankfurt, Germany

Location

Pa0011 40029

Hamburg, Germany

Location

Pa0011 40071

Hamburg, Germany

Location

Pa0011 40078

Leipzig, Germany

Location

Pa0011 40026

Ratingen, Germany

Location

Pa0011 40083

Budapest, Hungary

Location

Pa0011 40079

Szentes, Hungary

Location

Pa0011 40084

Catania, Italy

Location

Pa0011 40087

Milan, Italy

Location

Pa0011 40086

Reggio Emilia, Italy

Location

Pa0011 20030

Chūōku, Japan

Location

Pa0011 20043

Itabashi-ku, Japan

Location

Pa0011 20036

Kawachi-Nagano, Japan

Location

Pa0011 20045

Kita-gun, Japan

Location

Pa0011 20049

Kitakyushu, Japan

Location

Pa0011 20044

Minatoku, Japan

Location

Pa0011 20041

Osaka, Japan

Location

Pa0011 20046

Osaka, Japan

Location

Pa0011 20031

Sapporo, Japan

Location

Pa0011 20042

Sasebo, Japan

Location

Pa0011 20032

Suita, Japan

Location

Pa0011 40119

Bydgoszcz, Poland

Location

Pa0011 40038

Elblag, Poland

Location

Pa0011 40037

Lublin, Poland

Location

Pa0011 40091

Nowa Sól, Poland

Location

Pa0011 40044

Poznan, Poland

Location

Pa0011 40090

Poznan, Poland

Location

Pa0011 40118

Torun, Poland

Location

Pa0011 40041

Warsaw, Poland

Location

Pa0011 40097

Warsaw, Poland

Location

Pa0011 40098

Warsaw, Poland

Location

Pa0011 40039

Wroclaw, Poland

Location

Pa0011 40043

Wroclaw, Poland

Location

Pa0011 20005

Korolyov, Russia

Location

Pa0011 20010

Moscow, Russia

Location

Pa0011 20013

Petrozavodsk, Russia

Location

Pa0011 20001

Saint Petersburg, Russia

Location

Pa0011 20004

Saint Petersburg, Russia

Location

Pa0011 20009

Saint Petersburg, Russia

Location

Pa0011 20007

Saratov, Russia

Location

Pa0011 20014

Ulyanovsk, Russia

Location

Pa0011 20006

Vladimir, Russia

Location

Pa0011 20008

Yaroslavl, Russia

Location

Pa0011 20015

Yaroslavl, Russia

Location

Pa0011 40111

Bradford, United Kingdom

Location

Pa0011 40109

Oxford, United Kingdom

Location

Pa0011 40116

Stamford, United Kingdom

Location

Related Publications (16)

• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.

  PMID: 38446397 RESULT

• Warren RB, McInnes IB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, Mease PJ. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):829-839. doi: 10.1007/s40744-024-00659-0. Epub 2024 Mar 15.

  PMID: 38488975 RESULT

• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.

  PMID: 39120849 RESULT

• Kristensen LE, Tillett W, Nash P, Coates LC, Mease PJ, Ogdie A, Gisondi P, Ink B, Prickett AR, Bajracharya R, Taieb V, Lyris N, Lambert J, Walsh JA. Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies. Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.

  PMID: 39534481 RESULT

• Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2025 Aug;12(4):609-612. doi: 10.1007/s40744-025-00764-8. Epub 2025 May 10.

  PMID: 40347389 RESULT

• Thaci D, Asahina A, Boehncke WH, Gottlieb AB, Lebwohl M, Warren RB, Edens H, Ink B, Bajracharya R, Coarse J, Merola JF. Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year. Dermatol Ther (Heidelb). 2026 Feb;16(2):953-976. doi: 10.1007/s13555-025-01599-5. Epub 2025 Dec 12.

  PMID: 41381988 RESULT

• Gossec L, Coates LC, Landewe RBM, Mease PJ, Merola JF, Ritchlin CT, Tanaka Y, Asahina A, Proft F, Goldammer N, Manente M, Ink B, Bajracharya R, Coarse J, McInnes IB. Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies. Rheumatology (Oxford). 2026 Mar 16:keag118. doi: 10.1093/rheumatology/keag118. Online ahead of print.

  PMID: 41838419 DERIVED

• Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.

  PMID: 41807031 DERIVED

• Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.

  PMID: 40194794 DERIVED

• Gladman DD, Mease PJ, Gossec L, Husni ME, Gottlieb AB, Ink B, Bajracharya R, Coarse J, Lyris N, Lambert J, Tillett W. Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies. J Rheumatol. 2025 May 1;52(5):466-478. doi: 10.3899/jrheum.2024-0923.

  PMID: 39892885 DERIVED

• Husni ME, Mease PJ, Merola JF, Tillett W, Goldammer N, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies. RMD Open. 2024 Sep 23;10(3):e004464. doi: 10.1136/rmdopen-2024-004464.

  PMID: 39313302 DERIVED

• Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2024 Oct;11(5):1363-1382. doi: 10.1007/s40744-024-00708-8. Epub 2024 Aug 31.

  PMID: 39215949 DERIVED

• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.

  PMID: 39120848 DERIVED

• Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.

  PMID: 38754125 DERIVED

• Maloney A, Dua P, Ahmed GF. Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model-Based Meta-Analysis of American College of Rheumatology Response Criteria. Clin Pharmacol Ther. 2024 May;115(5):1007-1014. doi: 10.1002/cpt.3135. Epub 2024 Jan 12.

  PMID: 38073049 DERIVED

• Merola JF, Landewe R, McInnes IB, Mease PJ, Ritchlin CT, Tanaka Y, Asahina A, Behrens F, Gladman DD, Gossec L, Gottlieb AB, Thaci D, Warren RB, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Coates LC. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-alpha inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023 Jan 7;401(10370):38-48. doi: 10.1016/S0140-6736(22)02303-0. Epub 2022 Dec 6.

  PMID: 36495881 DERIVED

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; 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 (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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 1, 2019
• Study Start: March 28, 2019
• Primary Completion: December 8, 2021
• Study Completion: February 14, 2022
• Last Updated: January 28, 2026
• Results First Posted: October 16, 2024

Record last verified: 2026-01

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

AU (3); CZ (4); CA (3); PL (12); DE (7); RU (11); GB (3); IT (3); JP (11); HU (2); US (33)