A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis

Last updated: March 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Psoriatic Arthritis

Treatment

Placebo

JNJ-88545223

Clinical Study ID

NCT07321873
88545223PSA2001
2025-523141-10-00
88545223PSA2001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 >= 1 of the following PsA subsets: distal interphalangeal joint involvement,polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheralarthritis, or spondylitis with peripheral arthritis

  • Have active plaque psoriasis with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or 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 nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)

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

  • Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergicreaction, angioedema, or anaphylaxis to drugs or food

  • Has fibromyalgia or osteoarthritis symptoms that, in the opinion of theinvestigator, would have potential to interfere with efficacy assessments

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

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 15, 2026
Estimated Completion Date:
August 02, 2027

Connect with a study center

  • Peking University People's Hospital

    Beijing, 100044
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing 1816670, 100044
    China

    Site Not Available

  • Ningbo medical center lihuili hospital

    Ningbo, 315041
    China

    Active - Recruiting

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, 807-8556
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586
    Japan

    Active - Recruiting

  • Sanuki Municipal Hospital

    Sanuki, 769-2393
    Japan

    Active - Recruiting

  • Unity Health-White County Medical Center

    Searcy, Arkansas 72143
    United States

    Active - Recruiting

  • Unity Health-White County Medical Center

    Searcy 4130430, Arkansas 4099753 72143
    United States

    Site Not Available

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Rheumatology Center of San Diego

    San Diego, California 92128
    United States

    Active - Recruiting

  • Rheumatology Center of San Diego

    San Diego 5391811, California 5332921 92128
    United States

    Site Not Available

  • American Research, LLC

    Cutler Bay, Florida 33157
    United States

    Active - Recruiting

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • American Research, LLC

    Cutler Bay 6332309, Florida 4155751 33157
    United States

    Site Not Available

  • Conquest Research

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook 4916709, Illinois 4896861 60527
    United States

    Site Not Available

  • Qualmedica Research

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • Qualmedica Research

    Evansville 4257227, Indiana 4921868 47715
    United States

    Site Not Available

  • Joint and Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Joint and Muscle Research Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Paramount Medical Research & Consulting

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Paramount Medical Research & Consulting

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Site Not Available

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Clinical Research Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Site Not Available

  • Arthritis and Rheumatology Research Institute

    Allen, Texas 75013
    United States

    Active - Recruiting

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