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NCT07321873PHASE2Recruiting

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

Janssen Research & Development, LLC

Start Date

1/15/2026

Completion Date

8/2/2027

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-88545223

DRUG

Placebo

Interested in This Trial?

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Conditions

Arthritis, Psoriatic

Locations

Unity Health-White County Medical Center

Searcy, Arkansas 72143

United States

Newport Huntington Medical Group

Huntington Beach, California 92648

United States

Rheumatology Center of San Diego

San Diego, California 92128

United States

American Research, LLC

Cutler Bay, Florida 33157

United States

Innovation Medical Research Center

Palmetto Bay, Florida 33157

United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida 33324

United States

Clinical Research of West Florida

Tampa, Florida 33606

United States

Conquest Research

Winter Park, Florida 32789

United States

Atlanta Research Center for Rheumatology

Marietta, Georgia 30060

United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois 60527

United States

Qualmedica Research

Evansville, Indiana 47715

United States

Albuquerque Rehabilitation and Rheumatology

Albuquerque, New Mexico 87102

United States

Joint and Muscle Research Institute

Charlotte, North Carolina 28204

United States

Paramount Medical Research & Consulting

Middleburg Heights, Ohio 44130

United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania 19114

United States

Arthritis and Rheumatology Research Institute

Frisco, Texas 75035

United States

Peking University People's Hospital

Beijing, 100044

China

Peking University Third Hospital

Beijing, 100191

China

Beijing Tsinghua Changgung Hospital

Beijing, 102218

China

Xiangya Hospital Central South University

Changsha, 410008

China

Changzhou No 2 Peoples Hospital

Changzhou, 213003

China

West China Hospital Sichuan University

Chengdu, 610093

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016

China

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 310009

China

Ningbo medical center lihuili hospital

Ningbo, 315041

China

Shanghai Sixth People's Hospital

Shanghai, 200233

China

RHEUMA s r o

Břeclav, 690 02

Czechia

L K N Arthrocentrum

Hlučín, 748 01

Czechia

Revmatologicka ambulance

Karvina Frystat, 733 01

Czechia

Pratia Czech A S

Pardubice, 53002

Czechia

Clintrial s r o

Prague, 100 00

Czechia

Medical Plus Research S R O

Uherské Hradiště, 68601

Czechia

Fachklinik Bad Bentheim

Bad Bentheim, 48455

Germany

Charite Universitaetsmedizin Berlin

Berlin, 10117

Germany

Rheumatologische Schwerpunktpraxis

Berlin, 10777

Germany

Praxis Mario Sutowicz

Cottbus, 3042

Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095

Germany

CAIR Heidelberg

Heidelberg, 69121

Germany

Gemeinschaftspraxis Dres. Quist

Mainz, 55128

Germany

Hautarztpraxis Mortazawi

Remscheid, 42897

Germany

Hautarztpraxis

Witten, 58453

Germany

Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

Budapest, 1023

Hungary

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036

Hungary

Qualiclinic Kft

Budapest, 1134

Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700

Hungary

Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, 6800

Hungary

Complex Rendelo Med Zrt

Székesfehérvár, 8000

Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, 8200

Hungary

Tokyo Metropolitan Tama Medical Center

Fuchū, 183 8524

Japan

Imamura General Hospital

Kagoshima, 890-0064

Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, 807-8556

Japan

Osaka Metropolitan University Hospital

Osaka, 545 8586

Japan

Sanuki Municipal Hospital

Sanuki, 769-2393

Japan

Tokito Clinic Rheumatology and Orthopaedic Surgery

Shimonoseki, 752 0976

Japan

Nzoz Osteo Medic

Bialystok, 15 351

Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85 168

Poland

Centrum Kliniczno Badawcze

Elblag, 82-300

Poland

Malopolskie Badania Kliniczne Sp z o o

Krakow, 30-002

Poland

Pratia MCM Krakow

Krakow, 30-727

Poland

ETG Lublin

Lublin, 20 412

Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, 05-830

Poland

Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A

Olsztyn, 10 117

Poland

MICS Centrum Medyczne Torun

Torun, 87-100

Poland

MICS Centrum Medyczne Warszawa

Warsaw, 00 874

Poland

MICS Centrum Medyczne Warszawa 1

Warsaw, 00-872

Poland

Rheuma Medicus Sp z o o

Warsaw, 02 118

Poland

Centrum Medyczne Reuma Park

Warsaw, 02 665

Poland

FutureMeds Targowek

Warsaw, 03 291

Poland

Hosp Univ A Coruna

A Coruña, 15006

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Hosp. Infanta Luisa

Seville, 41010

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain