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

Last updated: June 4, 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 (Week 0/Day 1) based on the 66/68 jointassessment; AND (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1milligrams per deciliter (mg/dL) at screening from the central laboratory

  • 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 Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008
    China

    Active - Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213003
    China

    Active - Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610093
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, 310009
    China

    Active - Recruiting

  • Ningbo medical center lihuili hospital

    Ningbo, 315041
    China

    Active - Recruiting

  • RHEUMA s r o

    Břeclav, 690 02
    Czechia

    Active - Recruiting

  • L K N Arthrocentrum

    Hlučín, 748 01
    Czechia

    Active - Recruiting

  • Revmatologicka ambulance

    Karvina Frystat, 733 01
    Czechia

    Active - Recruiting

  • Pratia Czech A S

    Pardubice, 53002
    Czechia

    Active - Recruiting

  • Clintrial s r o

    Prague, 100 00
    Czechia

    Active - Recruiting

  • Medical Plus Research S R O

    Uherské Hradiště, 68601
    Czechia

    Active - Recruiting

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Active - Recruiting

  • Rheumatologische Schwerpunktpraxis

    Berlin, 12161
    Germany

    Active - Recruiting

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095
    Germany

    Active - Recruiting

  • CAIR Heidelberg

    Heidelberg, 69121
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Dres. Quist

    Mainz, 55128
    Germany

    Active - Recruiting

  • Hautarztpraxis Mortazawi

    Remscheid, 42897
    Germany

    Active - Recruiting

  • Hautarztpraxis

    Witten, 58453
    Germany

    Active - Recruiting

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Qualiclinic Kft

    Budapest, 1134
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

    Budapest, 1023
    Hungary

    Active - Recruiting

  • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

    Hódmezővásárhely, 6800
    Hungary

    Active - Recruiting

  • Complex Rendelo Med Zrt

    Székesfehérvár, 8000
    Hungary

    Active - Recruiting

  • Tokyo Metropolitan Tama Medical Center

    Fuchū, 183 8524
    Japan

    Active - Recruiting

  • Imamura General Hospital

    Kagoshima, 890-0064
    Japan

    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

  • Tokito Clinic Rheumatology and Orthopaedic Surgery

    Shimonoseki, 752 0976
    Japan

    Active - Recruiting

  • Nzoz Osteo Medic

    Bialystok, 15 351
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85 168
    Poland

    Active - Recruiting

  • Centrum Kliniczno Badawcze

    Elblag, 82-300
    Poland

    Active - Recruiting

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002
    Poland

    Active - Recruiting

  • Pratia MCM Krakow

    Krakow, 30-727
    Poland

    Active - Recruiting

  • ETG Lublin

    Lublin, 20 412
    Poland

    Active - Recruiting

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830
    Poland

    Active - Recruiting

  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A

    Olsztyn, 10 117
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Active - Recruiting

  • Centrum Medyczne Reuma Park

    Warsaw, 02 665
    Poland

    Active - Recruiting

  • FutureMeds Targowek

    Warsaw, 03 291
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00 874
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa 1

    Warsaw, 00-872
    Poland

    Active - Recruiting

  • Rheuma Medicus Sp z o o

    Warsaw, 02 118
    Poland

    Active - Recruiting

  • Hosp Univ A Coruna

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hosp. Infanta Luisa

    Seville, 41010
    Spain

    Active - Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009
    Spain

    Active - Recruiting

  • Unity Health-White County Medical Center

    Searcy, Arkansas 72143
    United States

    Active - Recruiting

  • 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

  • American Research, LLC

    Cutler Bay, Florida 33157
    United States

    Active - Recruiting

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    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

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Qualmedica Research

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • Albuquerque Rehabilitation and Rheumatology

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Joint and Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Paramount Medical Research & Consulting

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Arthritis and Rheumatology Research Institute

    Allen, Texas 75013
    United States

    Active - Recruiting

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