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

Last updated: April 10, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Bone Diseases

Treatment

Risankizumab

Bimekizumab

Placebo

Clinical Study ID

NCT06624228
PA0016
2024-511738-11
U1111-1306-6697
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study participants must have a documented diagnosis of adult-onset PsA classified byand that meets the CASPAR classification criteria for at least 6 months prior toScreening with active PsA (despite previous csDMARD or apremilast therapy) and musthave at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen jointcount (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 adocumented history of chronic plaque-type psoriasis (PSO).

  • Study participants may currently be on conventional synthetic disease-modifyingantirheumatic drug (csDMARD) therapy and must have previously been treated with atleast 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Studyparticipants must have had an inadequate response to therapy or discontinued due tointolerance. (Inadequate response is determined by the Investigator and is definedas 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 previouslymust not have discontinued the TNFα inhibitor due to financial or health insurancereasons and must have either:

  • experienced an inadequate response to previous treatment given at an approved dosefor at least 3 months, or

  • been intolerant to administration (eg, had a side-effect/adverse event (AE) that ledto discontinuation).

Exclusion

Exclusion Criteria:

  • Study participant has any medical or psychiatric condition that, in the opinion ofthe Investigator, could jeopardize or would compromise the study participant'sability to participate in this study.

  • Female participants who are breastfeeding, pregnant, or plan to become pregnantduring 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 TBinfection, or has current or history of nontuberculous mycobacterium (NTMB)infection.

  • Study participant has a diagnosis of inflammatory conditions other than PSO or PsAincluding, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupuserythematosus, reactive arthritis, and axial spondyloarthritis.

  • Study participants with a history of anterior uveitis are allowed if they have noactive symptoms at Screening or Baseline. Study participants with a diagnosis ofCrohn's disease or ulcerative colitis are allowed if they have no active symptomaticdisease at Screening or Baseline.

  • Study participants with fibromyalgia or osteoarthritis symptoms that in theInvestigator's opinion would have potential to interfere with efficacy assessments.

  • Participant has any active malignancy or history of malignancy within 5 years priorto the Screening Visit EXCEPT treated and considered cured cutaneous squamous orbasal cell carcinoma, or in situ cervical cancer.

  • Participant has a history of chronic alcohol or drug abuse within 6 months prior toScreening.

  • 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 analgesicsas outlined in the Inclusion criteria.

  • Study participant is taking or has taken prohibited PsA or PSO medications withoutmeeting 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 orrisankizumab, with the exception of having received 1 prior TNFα inhibitor.

  • Study participant previously participated in another study of a medical device underinvestigation within the 4 weeks prior to the Screening Visit or is currentlyparticipating in another study of a medical device under investigation.

Study Design

Total Participants: 550
Treatment Group(s): 3
Primary Treatment: Risankizumab
Phase: 3
Study Start date:
October 21, 2024
Estimated Completion Date:
July 15, 2026

Connect with a study center

  • Pa0016 30002

    Clayton,
    Australia

    Active - Recruiting

  • Pa0016 30033

    Heidelberg,
    Australia

    Active - Recruiting

  • Pa0016 30003

    Maroochydore,
    Australia

    Active - Recruiting

  • Pa0016 30032

    Parramatta,
    Australia

    Active - Recruiting

  • Pa0016 40313

    Pleven,
    Bulgaria

    Active - Recruiting

  • Pa0016 40813

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • Pa0016 40820

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • Pa0016 40823

    Ruse,
    Bulgaria

    Active - Recruiting

  • Pa0016 40656

    Russe,
    Bulgaria

    Active - Recruiting

  • Pa0016 40314

    Sofia,
    Bulgaria

    Active - Recruiting

  • Pa0016 40811

    Sofia,
    Bulgaria

    Active - Recruiting

  • Pa0016 40819

    Sofia,
    Bulgaria

    Active - Recruiting

  • Pa0016 50041

    Quebec,
    Canada

    Active - Recruiting

  • Pa0016 50044

    Trois-rivieres,
    Canada

    Active - Recruiting

  • Pa0016 40065

    Brno,
    Czechia

    Active - Recruiting

  • Pa0016 40062

    Ostrava,
    Czechia

    Active - Recruiting

  • Pa0016 40802

    Ostrava,
    Czechia

    Active - Recruiting

  • Pa0016 40801

    Praha 4,
    Czechia

    Active - Recruiting

  • Pa0016 40010

    Uherske Hradiste,
    Czechia

    Active - Recruiting

  • Pa0016 40012

    Zlin,
    Czechia

    Active - Recruiting

  • Pa0016 40025

    Berlin,
    Germany

    Active - Recruiting

  • Pa0016 40515

    Berlin,
    Germany

    Active - Recruiting

  • Pa0016 40138

    Bonn,
    Germany

    Active - Recruiting

  • Pa0016 40808

    Cologne,
    Germany

    Active - Recruiting

  • Pa0016 40029

    Hamburg,
    Germany

    Active - Recruiting

  • Pa0016 40810

    Herne,
    Germany

    Active - Recruiting

  • Pa0016 40724

    München,
    Germany

    Active - Recruiting

  • Pa0016 40800

    Ratingen,
    Germany

    Active - Recruiting

  • Pa0016 40081

    Budapest,
    Hungary

    Active - Recruiting

  • Pa0016 40804

    Budapest,
    Hungary

    Active - Recruiting

  • Pa0016 40809

    Hodmezovasarhely,
    Hungary

    Active - Recruiting

  • Pa0016 40031

    Szeged,
    Hungary

    Active - Recruiting

  • Pa0016 20035

    Bunkyo-ku,
    Japan

    Active - Recruiting

  • Pa0016 20043

    Itabashi-ku,
    Japan

    Active - Recruiting

  • Pa0016 20049

    Kitakyushu,
    Japan

    Active - Recruiting

  • Pa0016 20033

    Nagoya,
    Japan

    Active - Recruiting

  • Pa0016 20041

    Osaka,
    Japan

    Active - Recruiting

  • Pa0016 20046

    Osaka,
    Japan

    Active - Recruiting

  • Pa0016 20031

    Sapporo,
    Japan

    Active - Recruiting

  • Pa0016 20335

    Yokohama,
    Japan

    Active - Recruiting

  • Pa0016 40789

    Bialystok,
    Poland

    Active - Recruiting

  • Pa0016 40791

    Bialystok,
    Poland

    Active - Recruiting

  • Pa0016 40824

    Bialystok,
    Poland

    Active - Recruiting

  • Pa0016 40119

    Bydgoszcz,
    Poland

    Active - Recruiting

  • Pa0016 40798

    Bydgoszcz,
    Poland

    Active - Recruiting

  • Pa0016 40038

    Elblag,
    Poland

    Active - Recruiting

  • Pa0016 40795

    Katowice,
    Poland

    Active - Recruiting

  • Pa0016 40092

    Krakow,
    Poland

    Active - Recruiting

  • Pa0016 40490

    Krakow,
    Poland

    Site Not Available

  • Pa0016 40502

    Krakow,
    Poland

    Active - Recruiting

  • Pa0016 40792

    Krakow,
    Poland

    Active - Recruiting

  • Pa0016 40037

    Lublin,
    Poland

    Active - Recruiting

  • Pa0016 40483

    Nadarzyn,
    Poland

    Active - Recruiting

  • Pa0016 40091

    Nowa Sol,
    Poland

    Active - Recruiting

  • Pa0016 40796

    Olsztyn,
    Poland

    Active - Recruiting

  • Pa0016 40794

    Opole,
    Poland

    Active - Recruiting

  • Pa0016 40044

    Poznan,
    Poland

    Active - Recruiting

  • Pa0016 40090

    Poznan,
    Poland

    Active - Recruiting

  • Pa0016 40807

    Poznan,
    Poland

    Active - Recruiting

  • Pa0016 40790

    Sochaczew,
    Poland

    Site Not Available

  • Pa0016 40788

    Torun,
    Poland

    Active - Recruiting

  • Pa0016 40094

    Warszawa,
    Poland

    Active - Recruiting

  • Pa0016 40394

    Warszawa,
    Poland

    Active - Recruiting

  • Pa0016 40539

    Warszawa,
    Poland

    Active - Recruiting

  • Pa0016 40604

    Warszawa,
    Poland

    Active - Recruiting

  • Pa0016 40793

    Warszawa,
    Poland

    Active - Recruiting

  • Pa0016 40797

    Warszawa,
    Poland

    Active - Recruiting

  • Pa0016 40043

    Wroclaw,
    Poland

    Active - Recruiting

  • Pa0016 40095

    Wroclaw,
    Poland

    Active - Recruiting

  • Pa0016 40805

    Wroclaw,
    Poland

    Active - Recruiting

  • Pa0016 40806

    A Coruna,
    Spain

    Active - Recruiting

  • Pa0016 40231

    Madrid,
    Spain

    Active - Recruiting

  • Pa0016 40102

    Málaga,
    Spain

    Active - Recruiting

  • Pa0016 40753

    Santiago de Compostela,
    Spain

    Active - Recruiting

  • Pa0016 40049

    Sevilla,
    Spain

    Active - Recruiting

  • Pa0016 40799

    Sevilla,
    Spain

    Active - Recruiting

  • Pa0016 40828

    Reading,
    United Kingdom

    Active - Recruiting

  • Pa0016 50662

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Pa0016 50062

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Pa0016 50058

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Pa0016 50677

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Pa0016 50131

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Pa0016 50654

    Covina, California 91722
    United States

    Active - Recruiting

  • Pa0016 50663

    San Diego, California 92128
    United States

    Active - Recruiting

  • Pa0016 50672

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Pa0016 50239

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Pa0016 50630

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Pa0016 50679

    Cutler Bay, Florida 33189
    United States

    Active - Recruiting

  • Pa0016 50685

    Fort Lauderdale, Florida 33309
    United States

    Active - Recruiting

  • Pa0016 50059

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Pa0016 50678

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Pa0016 50650

    Hinsdale, Illinois 60521-3186
    United States

    Site Not Available

  • Pa0016 50651

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Pa0016 50650

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Pa0016 50686

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Pa0016 50665

    Okemos, Michigan 48864
    United States

    Active - Recruiting

  • Pa0016 50551

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Pa0016 50689

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • Pa0016 50682

    Kansas City, Missouri 64151
    United States

    Active - Recruiting

  • Pa0016 50016

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Pa0016 50653

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Pa0016 50666

    Brooklyn, New York 11201
    United States

    Active - Recruiting

  • Pa0016 50521

    New York, New York 10003
    United States

    Active - Recruiting

  • Pa0016 50664

    Middletown, Ohio 45044
    United States

    Active - Recruiting

  • Pa0016 50680

    Vandalia, Ohio 45377
    United States

    Active - Recruiting

  • Pa0016 50652

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Pa0016 50006

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Pa0016 50001

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Pa0016 50048

    Baytown, Texas 77521
    United States

    Active - Recruiting

  • Pa0016 50673

    Fort Worth, Texas 76109
    United States

    Active - Recruiting

  • Pa0016 50657

    Lubbock, Texas 79424
    United States

    Active - Recruiting

  • Pa0016 50655

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Pa0016 50061

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Pa0016 50674

    Glendale, Wisconsin 53217
    United States

    Active - Recruiting

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