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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07321873

Registry updated: 2026-09-25
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Description

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.

Interventions

  • JNJ-88545223 (Drug)
    JNJ-88545223 will be administered.
  • Placebo (Drug)
    Placebo will be administered.

Eligibility criteria

Inclusion Criteria: * Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening * Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (Week 0/Day 1) based on the 66/68 joint assessment; AND (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams 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 peripheral arthritis, 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 sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention 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 uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances * Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food * Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments * Currently has a malignancy or has a history of malignancy within 5 years prior to screening

Conditions

Arthritis, Psoriatic

Locations

  • Unity Health-White County Medical Center — Searcy, Arkansas, United States
  • Newport Huntington Medical Group — Huntington Beach, California, United States
  • Rheumatology Center of San Diego — San Diego, California, United States
  • Clinical Research of West Florida 1 — Clearwater, Florida, United States
  • American Research, LLC — Cutler Bay, Florida, United States
  • Innovation Medical Research Center — Palmetto Bay, Florida, United States
  • Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States
  • Clinical Research of West Florida — Tampa, Florida, United States
  • Conquest Research — Winter Park, Florida, United States
  • Atlanta Research Center for Rheumatology — Marietta, Georgia, United States
  • Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States
  • Qualmedica Research — Evansville, Indiana, United States
  • Albuquerque Rehabilitation and Rheumatology — Albuquerque, New Mexico, United States
  • Joint and Muscle Research Institute — Charlotte, North Carolina, United States
  • Onsite Clinical Solutions — Salisbury, North Carolina, United States
  • Paramount Medical Research & Consulting — Middleburg Heights, Ohio, United States
  • Clinical Research Philadelphia — Philadelphia, Pennsylvania, United States
  • Arthritis and Rheumatology Research Institute — Frisco, Texas, United States
  • Peking University People's Hospital — Beijing, China
  • Peking University Third Hospital — Beijing, China
  • Beijing Tsinghua Changgung Hospital — Beijing, China
  • Xiangya Hospital Central South University — Changsha, China
  • Changzhou No 2 Peoples Hospital — Changzhou, China
  • West China Hospital Sichuan University — Chengdu, China
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
  • The Second Affiliated Hospital of Zhejiang University — Hangzhou, China
  • Ningbo medical center lihuili hospital — Ningbo, China
  • Shanghai Sixth People's Hospital — Shanghai, China
  • RHEUMA s r o — Břeclav, Czechia
  • L K N Arthrocentrum — Hlučín, Czechia
  • Revmatologicka ambulance — Karvina Frystat, Czechia
  • Pratia Czech A S — Pardubice, Czechia
  • Clintrial s r o — Prague, Czechia
  • Medical Plus Research S R O — Uherské Hradiště, Czechia
  • Fachklinik Bad Bentheim — Bad Bentheim, Germany
  • Charite Universitaetsmedizin Berlin — Berlin, Germany
  • Rheumatologische Schwerpunktpraxis — Berlin, Germany
  • Praxis Mario Sutowicz — Cottbus, Germany
  • Hamburger Rheuma Forschungszentrum II — Hamburg, Germany
  • CAIR Heidelberg — Heidelberg, Germany
  • Gemeinschaftspraxis Dres. Quist — Mainz, Germany
  • Hautarztpraxis Mortazawi — Remscheid, Germany
  • Hautarztpraxis — Witten, Germany
  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika — Budapest, Hungary
  • Obudai Egeszsegugyi Centrum Kft — Budapest, Hungary
  • Qualiclinic Kft — Budapest, Hungary
  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz — Gyula, Hungary
  • Porcika Klinika - Vasarhelyi Sarkanyfu Kft. — Hódmezővásárhely, Hungary
  • Complex Rendelo Med Zrt — Székesfehérvár, Hungary
  • Vital Medical Center Orvosi es Fogaszati Kozpont — Veszprém, Hungary
  • Tokyo Metropolitan Tama Medical Center — Fuchū, Japan
  • Imamura General Hospital — Kagoshima, Japan
  • Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi, Japan
  • Osaka Metropolitan University Hospital — Osaka, Japan
  • Sanuki Municipal Hospital — Sanuki, Japan
  • Tokito Clinic Rheumatology and Orthopaedic Surgery — Shimonoseki, Japan
  • Nzoz Osteo Medic — Bialystok, Poland
  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy — Bydgoszcz, Poland
  • Centrum Kliniczno Badawcze — Elblag, Poland
  • Malopolskie Badania Kliniczne Sp z o o — Krakow, Poland
  • Pratia MCM Krakow — Krakow, Poland
  • ETG Lublin — Lublin, Poland
  • NZOZ Lecznica MAK MED S C — Nadarzyn, Poland
  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A — Olsztyn, Poland
  • MICS Centrum Medyczne Torun — Torun, Poland
  • MICS Centrum Medyczne Warszawa — Warsaw, Poland
  • MICS Centrum Medyczne Warszawa 1 — Warsaw, Poland
  • Rheuma Medicus Sp z o o — Warsaw, Poland
  • Centrum Medyczne Reuma Park — Warsaw, Poland
  • FutureMeds Targowek — Warsaw, Poland
  • Hosp Univ A Coruna — A Coruña, Spain
  • Hosp. Clinico Univ. de Santiago — Santiago de Compostela, Spain
  • Hosp. Virgen Macarena — Seville, Spain
  • Hosp. Infanta Luisa — Seville, Spain
  • Hosp. Virgen Del Rocio — Seville, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record