A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

June 4, 2026 updated by: UCB Biopharma SRL

A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

684

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia
        • Pa0016 30002
      • Footscray, Australia
        • Pa0016 30034
      • Heidelberg, Australia
        • Pa0016 30033
      • Maroochydore, Australia
        • Pa0016 30003
      • Parramatta, Australia
        • Pa0016 30032
      • Westmead, Australia
        • Pa0016 30009
  • Bulgaria
      • Pleven, Bulgaria
        • Pa0016 40313
      • Plovdiv, Bulgaria
        • Pa0016 40006
      • Plovdiv, Bulgaria
        • Pa0016 40813
      • Plovdiv, Bulgaria
        • Pa0016 40818
      • Plovdiv, Bulgaria
        • Pa0016 40820
      • Rousse, Bulgaria
        • Pa0016 40656
      • Rousse, Bulgaria
        • Pa0016 40823
      • Sofia, Bulgaria
        • Pa0016 40314
      • Sofia, Bulgaria
        • Pa0016 40380
      • Sofia, Bulgaria
        • Pa0016 40811
      • Sofia, Bulgaria
        • Pa0016 40819
  • Canada
      • Québec, Canada
        • Pa0016 50041
      • Trois-Rivières, Canada
        • Pa0016 50044
  • Czechia
      • Brno, Czechia
        • Pa0016 40065
      • Moravska Ostrava A Privoz, Czechia
        • Pa0016 40062
      • Ostrava, Czechia
        • Pa0016 40802
      • Prague, Czechia
        • Pa0016 40066
      • Prague, Czechia
        • Pa0016 40801
      • Uherské Hradiště, Czechia
        • Pa0016 40010
      • Zlín, Czechia
        • Pa0016 40012
  • Germany
      • Bad Nauheim, Germany
        • Pa0016 40073
      • Berlin, Germany
        • Pa0016 40025
      • Bonn, Germany
        • Pa0016 40138
      • Cologne, Germany
        • Pa0016 40808
      • Freiburg im Breisgau, Germany
        • Pa0016 40072
      • Hamburg, Germany
        • Pa0016 40029
      • Herne, Germany
        • Pa0016 40810
      • München, Germany
        • Pa0016 40724
      • Ratingen, Germany
        • Pa0016 40800
  • Hungary
      • Budapest, Hungary
        • Pa0016 40081
      • Budapest, Hungary
        • Pa0016 40804
      • Hódmezővásárhely, Hungary
        • Pa0016 40809
      • Szeged, Hungary
        • Pa0016 40031
  • Japan
      • Bunkyō City, Japan
        • Pa0016 20035
      • Itabashi-ku, Japan
        • Pa0016 20043
      • Kita-gun, Japan
        • Pa0016 20045
      • Kitakyushu, Japan
        • Pa0016 20049
      • Meguro-ku, Japan
        • Pa0016 20069
      • Mitaka-shi, Japan
        • Pa0016 20336
      • Osaka, Japan
        • Pa0016 20046
      • Osaka, Japan
        • Pa0016 20041
      • Sapporo, Japan
        • Pa0016 20031
  • Poland
      • Bialystok, Poland
        • Pa0016 40789
      • Bialystok, Poland
        • Pa0016 40791
      • Bialystok, Poland
        • Pa0016 40824
      • Bydgoszcz, Poland
        • Pa0016 40119
      • Bydgoszcz, Poland
        • Pa0016 40798
      • Elblag, Poland
        • Pa0016 40038
      • Katowice, Poland
        • Pa0016 40795
      • Krakow, Poland
        • Pa0016 40092
      • Krakow, Poland
        • Pa0016 40490
      • Krakow, Poland
        • Pa0016 40502
      • Krakow, Poland
        • Pa0016 40792
      • Lublin, Poland
        • Pa0016 40037
      • Nadarzyn, Poland
        • Pa0016 40483
      • Nowa Sól, Poland
        • Pa0016 40091
      • Olsztyn, Poland
        • Pa0016 40796
      • Opole, Poland
        • Pa0016 40794
      • Poznan, Poland
        • Pa0016 40044
      • Poznan, Poland
        • Pa0016 40090
      • Poznan, Poland
        • Pa0016 40807
      • Sochaczew, Poland
        • Pa0016 40790
      • Torun, Poland
        • Pa0016 40788
      • Warsaw, Poland
        • Pa0016 40094
      • Warsaw, Poland
        • Pa0016 40394
      • Warsaw, Poland
        • Pa0016 40539
      • Warsaw, Poland
        • Pa0016 40604
      • Warsaw, Poland
        • Pa0016 40793
      • Warsaw, Poland
        • Pa0016 40797
      • Wroclaw, Poland
        • Pa0016 40043
      • Wroclaw, Poland
        • Pa0016 40095
      • Wroclaw, Poland
        • Pa0016 40805
  • Spain
      • A Coruña, Spain
        • Pa0016 40806
      • Bilbao, Spain
        • Pa0016 40269
      • Madrid, Spain
        • Pa0016 40231
      • Málaga, Spain
        • Pa0016 40102
      • Sabadell, Spain
        • Pa0016 40803
      • Santiago de Compostela, Spain
        • Pa0016 40753
      • Seville, Spain
        • Pa0016 40049
      • Seville, Spain
        • Pa0016 40799
  • United Kingdom
      • Barnet, United Kingdom
        • Pa0016 40833
      • Leeds, United Kingdom
        • Pa0016 40281
      • Luton, United Kingdom
        • Pa0016 40827
      • Manchester, United Kingdom
        • Pa0016 40237
      • Newcastle upon Tyne, United Kingdom
        • Pa0016 40306
      • Reading, United Kingdom
        • Pa0016 40828
      • Salford, United Kingdom
        • Pa0016 40108
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Pa0016 50662
      • Glendale, Arizona, United States, 85306
        • Pa0016 50062
      • Phoenix, Arizona, United States, 85032
        • Pa0016 50058
      • Sun City, Arizona, United States, 85351
        • Pa0016 50131
    • California
      • Covina, California, United States, 91722
        • Pa0016 50654
      • San Diego, California, United States, 92128
        • Pa0016 50663
      • Santa Monica, California, United States, 90404
        • Pa0016 50672
    • Florida
      • Clearwater, Florida, United States, 33765
        • Pa0016 50630
      • Cutler Bay, Florida, United States, 33189
        • Pa0016 50679
      • Fort Lauderdale, Florida, United States, 33309
        • Pa0016 50685
      • Ormond Beach, Florida, United States, 32174
        • Pa0016 50059
      • Plantation, Florida, United States, 33324
        • Pa0016 50324
      • Zephyrhills, Florida, United States, 33542
        • Pa0016 50678
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Pa0016 50651
      • Willowbrook, Illinois, United States, 60527
        • Pa0016 50650
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Pa0016 50686
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Pa0016 50665
      • Saint Clair Shores, Michigan, United States, 48081
        • Pa0016 50551
    • Minnesota
      • Eagan, Minnesota, United States, 55123
        • Pa0016 50689
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Pa0016 50682
      • St Louis, Missouri, United States, 63141
        • Pa0016 50016
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pa0016 50653
    • New York
      • Brooklyn, New York, United States, 11201
        • Pa0016 50666
    • Ohio
      • Middletown, Ohio, United States, 45044
        • Pa0016 50664
      • Vandalia, Ohio, United States, 45377
        • Pa0016 50680
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pa0016 50652
      • Wyomissing, Pennsylvania, United States, 19610
        • Pa0016 50006
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Pa0016 50001
    • Texas
      • Fort Worth, Texas, United States, 76109
        • Pa0016 50673
      • Katy, Texas, United States, 77449
        • Pa0016 50048
      • Lubbock, Texas, United States, 79424
        • Pa0016 50657
      • Tomball, Texas, United States, 77375
        • Pa0016 50655
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Pa0016 50061
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Pa0016 50674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).
  • Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).
  • Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)
  • Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either:
  • experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or
  • been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation).

Exclusion Criteria:

  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
  • Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study.
  • Participant has an active infection or a history of recent serious infections.
  • Participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
  • Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis.
  • Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.
  • Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator's opinion would have potential to interfere with efficacy assessments.
  • Participant 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.
  • Participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  • Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.
  • Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit or is taking or has taken weight management medications without meeting the mandatory dose stability period/washout period relative to the Baseline Visit.
  • Study participant is taking or has taken janus kinase (JAK) inhibitor.
  • Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor.
  • Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimekizumab
Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.
Drug: Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Drug: Placebo
Study participants will receive placebo at pre-specified time points.
Active Comparator: Risankizumab
Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.
Drug: Placebo
Study participants will receive placebo at pre-specified time points.
Drug: Risankizumab
Study participants will receive risankizumab at pre-specified time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 50 (ACR50) at Week 16
Time Frame: Week 16

The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.

  • TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms)
  • Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain).
  • Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability.
  • High sensitivity C-reactive protein (hs-CRP) in mg/L
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Disease Activity (MDA) at Week 16
Time Frame: Week 16

A study participant is considered as having MDA if 5 or more of the following 7 criteria are fulfilled:

  • Tender joint count ≤1
  • Swollen joint count ≤1
  • PASI ≤1 or BSA ≤3
  • PtAAP VAS ≤15
  • PGA-PsA VAS ≤20
  • HAQ-DI ≤0.5
  • Tender enthesial points ≤1
Week 16
Percentage of participants reaching the composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline
Time Frame: Week 16

The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.

The PASI100 response is based on at least 100% improvement in the PASI score. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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
American College of Rheumatology 50 (ACR50) at Week 4
Time Frame: Week 4

The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.

  • TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms)
  • Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain).
  • Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability.
  • High sensitivity C-reactive protein (hs-CRP) in mg/L
Week 4
Incidence of Participants With Treatment-emergent adverse events (TEAEs)
Time Frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)
Incidence of Participants With Treatment-emergent serious AEs
Time Frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect
  • Results in permanent or significant disability/incapacity
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)
Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)
Time Frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)
An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Actual)

February 6, 2026

Study Completion (Estimated)

June 5, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA0016
  • 2024-511738-11 (Registry Identifier: EU Clinical Trials)
  • U1111-1306-6697 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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