A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
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
3 other identifiers
interventional
684
11 countries
127
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 2, 2024
CompletedStudy Start
First participant enrolled
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2026
ExpectedApril 13, 2026
April 1, 2026
1.3 years
September 30, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology 50 (ACR50) at 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 Outcomes (5)
Minimal Disease Activity (MDA) at Week 16
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
Week 16
Incidence of Participants With Treatment-emergent adverse events (TEAEs)
From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
Incidence of Participants With Treatment-emergent serious AEs
From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)
From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
Study Arms (2)
Bimekizumab
EXPERIMENTALStudy participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.
Risankizumab
ACTIVE COMPARATORStudy participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.
Interventions
Study participants will receive placebo at pre-specified time points.
Study participants will receive risankizumab at pre-specified time points.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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 participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
Pa0016 50662
Gilbert, Arizona, 85297, United States
Pa0016 50062
Glendale, Arizona, 85306, United States
Pa0016 50058
Phoenix, Arizona, 85032, United States
Pa0016 50131
Sun City, Arizona, 85351, United States
Pa0016 50654
Covina, California, 91722, United States
Pa0016 50663
San Diego, California, 92128, United States
Pa0016 50672
Santa Monica, California, 90404, United States
Pa0016 50630
Clearwater, Florida, 33765, United States
Pa0016 50679
Cutler Bay, Florida, 33189, United States
Pa0016 50685
Fort Lauderdale, Florida, 33309, United States
Pa0016 50059
Ormond Beach, Florida, 32174, United States
Pa0016 50324
Plantation, Florida, 33324, United States
Pa0016 50678
Zephyrhills, Florida, 33542, United States
Pa0016 50651
Skokie, Illinois, 60076, United States
Pa0016 50650
Willowbrook, Illinois, 60527, United States
Pa0016 50686
Hagerstown, Maryland, 21740, United States
Pa0016 50665
Lansing, Michigan, 48910, United States
Pa0016 50551
Saint Clair Shores, Michigan, 48081, United States
Pa0016 50689
Eagan, Minnesota, 55123, United States
Pa0016 50682
Kansas City, Missouri, 64111, United States
Pa0016 50016
St Louis, Missouri, 63141, United States
Pa0016 50653
Albuquerque, New Mexico, 87102, United States
Pa0016 50666
Brooklyn, New York, 11201, United States
Pa0016 50664
Middletown, Ohio, 45044, United States
Pa0016 50680
Vandalia, Ohio, 45377, United States
Pa0016 50652
Duncansville, Pennsylvania, 16635, United States
Pa0016 50006
Wyomissing, Pennsylvania, 19610, United States
Pa0016 50001
Jackson, Tennessee, 38305, United States
Pa0016 50673
Fort Worth, Texas, 76109, United States
Pa0016 50048
Katy, Texas, 77449, United States
Pa0016 50657
Lubbock, Texas, 79424, United States
Pa0016 50655
Tomball, Texas, 77375, United States
Pa0016 50061
Spokane Valley, Washington, 99216, United States
Pa0016 50674
Glendale, Wisconsin, 53217, United States
Pa0016 30002
Clayton, Australia
Pa0016 30034
Footscray, Australia
Pa0016 30033
Heidelberg, Australia
Pa0016 30003
Maroochydore, Australia
Pa0016 30032
Parramatta, Australia
Pa0016 30009
Westmead, Australia
Pa0016 40313
Pleven, Bulgaria
Pa0016 40006
Plovdiv, Bulgaria
Pa0016 40813
Plovdiv, Bulgaria
Pa0016 40818
Plovdiv, Bulgaria
Pa0016 40820
Plovdiv, Bulgaria
Pa0016 40656
Rousse, Bulgaria
Pa0016 40823
Rousse, Bulgaria
Pa0016 40314
Sofia, Bulgaria
Pa0016 40380
Sofia, Bulgaria
Pa0016 40811
Sofia, Bulgaria
Pa0016 40819
Sofia, Bulgaria
Pa0016 50041
Québec, Canada
Pa0016 50044
Trois-Rivières, Canada
Pa0016 40065
Brno, Czechia
Pa0016 40062
Moravska Ostrava A Privoz, Czechia
Pa0016 40802
Ostrava, Czechia
Pa0016 40066
Prague, Czechia
Pa0016 40801
Prague, Czechia
Pa0016 40010
Uherské Hradiště, Czechia
Pa0016 40012
Zlín, Czechia
Pa0016 40073
Bad Nauheim, Germany
Pa0016 40025
Berlin, Germany
Pa0016 40138
Bonn, Germany
Pa0016 40808
Cologne, Germany
Pa0016 40072
Freiburg im Breisgau, Germany
Pa0016 40029
Hamburg, Germany
Pa0016 40810
Herne, Germany
Pa0016 40724
München, Germany
Pa0016 40800
Ratingen, Germany
Pa0016 40081
Budapest, Hungary
Pa0016 40804
Budapest, Hungary
Pa0016 40809
Hódmezővásárhely, Hungary
Pa0016 40031
Szeged, Hungary
Pa0016 20035
Bunkyō City, Japan
Pa0016 20043
Itabashi-ku, Japan
Pa0016 20045
Kita-gun, Japan
Pa0016 20049
Kitakyushu, Japan
Pa0016 20069
Meguro-ku, Japan
Pa0016 20336
Mitaka-shi, Japan
Pa0016 20041
Osaka, Japan
Pa0016 20046
Osaka, Japan
Pa0016 20031
Sapporo, Japan
Pa0016 40789
Bialystok, Poland
Pa0016 40791
Bialystok, Poland
Pa0016 40824
Bialystok, Poland
Pa0016 40119
Bydgoszcz, Poland
Pa0016 40798
Bydgoszcz, Poland
Pa0016 40038
Elblag, Poland
Pa0016 40795
Katowice, Poland
Pa0016 40092
Krakow, Poland
Pa0016 40490
Krakow, Poland
Pa0016 40502
Krakow, Poland
Pa0016 40792
Krakow, Poland
Pa0016 40037
Lublin, Poland
Pa0016 40483
Nadarzyn, Poland
Pa0016 40091
Nowa Sól, Poland
Pa0016 40796
Olsztyn, Poland
Pa0016 40794
Opole, Poland
Pa0016 40044
Poznan, Poland
Pa0016 40090
Poznan, Poland
Pa0016 40807
Poznan, Poland
Pa0016 40790
Sochaczew, Poland
Pa0016 40788
Torun, Poland
Pa0016 40094
Warsaw, Poland
Pa0016 40394
Warsaw, Poland
Pa0016 40539
Warsaw, Poland
Pa0016 40604
Warsaw, Poland
Pa0016 40793
Warsaw, Poland
Pa0016 40797
Warsaw, Poland
Pa0016 40043
Wroclaw, Poland
Pa0016 40095
Wroclaw, Poland
Pa0016 40805
Wroclaw, Poland
Pa0016 40806
A Coruña, Spain
Pa0016 40269
Bilbao, Spain
Pa0016 40231
Madrid, Spain
Pa0016 40102
Málaga, Spain
Pa0016 40803
Sabadell, Spain
Pa0016 40753
Santiago de Compostela, Spain
Pa0016 40049
Seville, Spain
Pa0016 40799
Seville, Spain
Pa0016 40833
Barnet, United Kingdom
Pa0016 40281
Leeds, United Kingdom
Pa0016 40827
Luton, United Kingdom
Pa0016 40237
Manchester, United Kingdom
Pa0016 40306
Newcastle upon Tyne, United Kingdom
Pa0016 40828
Reading, United Kingdom
Pa0016 40108
Salford, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
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
September 30, 2024
First Posted
October 2, 2024
Study Start
October 21, 2024
Primary Completion
February 6, 2026
Study Completion (Estimated)
May 26, 2026
Last Updated
April 13, 2026
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.
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.