A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis

Last updated: April 3, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Placebo

Icotrokinra

Clinical Study ID

NCT06807424
77242113PSA3002
77242113PSA3002
2024-517284-23-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have been previously treated with 1 biologic agent for psoriaticarthritis (PsA) or psoriasis and the reason for discontinuation must be documented

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the firstadministration of study intervention and meet classification criteria for PsoriaticArthritis (CASPAR) at screening

  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tenderjoints at screening and at baseline (b) C-reactive protein (CRP) greater than orequal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the centrallaboratory.

  • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement,polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans,asymmetric peripheral arthritis, or spondylitis with peripheral arthritis

  • Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameteror nail changes consistent with psoriasis

  • A female participant of childbearing potential must have a negative highly sensitiveserum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test atWeek 0 prior to administration of study intervention

Exclusion

Exclusion Criteria:

  • Has a history or current signs or symptoms of severe, progressive, or uncontrolledrenal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine,neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric,genitourinary, or metabolic disturbances

  • Currently has a malignancy or has a history of malignancy within 5 years prior toscreening

  • Has known allergies, hypersensitivity, or intolerance to icotrokinra or itsexcipients

  • Has other inflammatory diseases that might confound the evaluations of benefit oficotrokinra therapy, including but not limited to rheumatoid arthritis (RA),systemic lupus erythematosus, or Lyme disease

  • Participants with fibromyalgia or osteoarthritis symptoms that, in theinvestigator's opinion, would have potential to interfere with efficacy assessments

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 09, 2025
Estimated Completion Date:
October 18, 2028

Connect with a study center

  • Rheumatology Research Unit

    Maroochydore, 4558
    Australia

    Active - Recruiting

  • Centre de Recherche Musculo Squelettique

    Trois Rivieres, Quebec G9A 3X2
    Canada

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515
    China

    Active - Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004
    China

    Active - Recruiting

  • Jinhua municipal central hospital

    Jinhua, 321013
    China

    Active - Recruiting

  • Linyi City People Hospital

    Linyi City, 276002
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, 226001
    China

    Active - Recruiting

  • Pingxiang People's Hospital

    Pingxiang, 337055
    China

    Active - Recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, 030032
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
    China

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • St. Luke's International Hospital

    Chuo ku, 104 8560
    Japan

    Active - Recruiting

  • Kita-harima Medical Center

    Hyogo, 6751392
    Japan

    Active - Recruiting

  • Maeshima Rheumatology Clinic

    Oita, 870 0823
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586
    Japan

    Active - Recruiting

  • Sanuki Municipal Hospital

    Sanuki, 7692393
    Japan

    Active - Recruiting

  • Sasebo Chuo Hospital

    Sasebo, 857 1195
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu, 514 8507
    Japan

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

  • Chi Mei Medical Center

    Tainan, 710
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Songklanagarind hospital

    Songkhla, 90110
    Thailand

    Active - Recruiting

  • Haywood Hospital

    Staffordshire, ST6 7AG
    United Kingdom

    Active - Recruiting

  • Arthritis and Rheumatism Associates ARA Jonesboro

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Clinical Research of West Florida

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Clinic of Robert Hozman

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Klein And Associates M D P A

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • St Paul Rheumatology PA

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • Joint and Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Rheumatology Associates of Oklahoma

    Oklahoma City, Oklahoma 73116
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

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