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RECRUITING

NCT07321873

PHASE2

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

View on ClinicalTrials.gov

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.

Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 For the Treatment of Participants With Active Psoriatic Arthritis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-01-15

Completion Date

2027-08-02

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Arthritis, Psoriatic

Interventions

DRUG

JNJ-88545223

JNJ-88545223 will be administered.

DRUG

Placebo

Placebo will be administered.

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

Locations (72)

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

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

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania, United States

Arthritis and Rheumatology Research Institute

Allen, 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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)