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

NCT07321873 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 88545223PSA20012025-523141-10-00
• Study Type: interventional
• Target: 240
• Locations: 8 countries
• Sites: 73

Brief 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.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16

  The ACR 50 responders are participants with an improvement of greater than or equal to (\>=) 50 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale \[VAS\], patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

  Week 16

Secondary Outcomes (7)

• Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%)

  Week 16

• Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3%

  Week 16

• Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3%

  Week 16

• Proportion of Participants who Achieved an ACR 20 Response at Week 16

  Week 16

• Proportion of Participants who Achieved an ACR 70 Response at Week 16

  Week 16

Other Outcomes (2)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 20

• Number of Participants With Change from Baseline in the Laboratory Parameters

  Baseline up to Week 20

Study Arms (4)

Arm 1: Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.

Drug: Placebo

Arm 2: JNJ-88545223 Dose 1

EXPERIMENTAL

Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.

Drug: JNJ-88545223

Arm 3: JNJ-88545223 Dose 2

EXPERIMENTAL

Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.

Drug: JNJ-88545223

Arm 4: JNJ-88545223 Dose 3

EXPERIMENTAL

Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.

Drug: JNJ-88545223

Interventions

JNJ-88545223 DRUG

JNJ-88545223 will be administered.

Arm 2: JNJ-88545223 Dose 1; Arm 3: JNJ-88545223 Dose 2; Arm 4: JNJ-88545223 Dose 3

Placebo DRUG

Placebo will be administered.

Arm 1: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (73)

Unity Health-White County Medical Center

Searcy, Arkansas, 72143, United States

RECRUITING

Newport Huntington Medical Group

Huntington Beach, California, 92648, United States

RECRUITING

Rheumatology Center of San Diego

San Diego, California, 92128, United States

RECRUITING

American Research, LLC

Cutler Bay, Florida, 33157, United States

RECRUITING

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

RECRUITING

Integral Rheumatology And Immunology Specialists

Plantation, Florida, 33324, United States

RECRUITING

Clinical Research of West Florida

Tampa, Florida, 33606, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060, United States

RECRUITING

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527, United States

RECRUITING

Qualmedica Research

Evansville, Indiana, 47715, United States

RECRUITING

Albuquerque Rehabilitation and Rheumatology

Albuquerque, New Mexico, 87102, United States

RECRUITING

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Clinical Research Philadelphia

Philadelphia, Pennsylvania, 19114, United States

RECRUITING

Arthritis and Rheumatology Research Institute

Frisco, Texas, 75035, United States

RECRUITING

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

RECRUITING

Xiangya Hospital Central South University

Changsha, 410008, China

RECRUITING

Changzhou No 2 Peoples Hospital

Changzhou, 213003, China

RECRUITING

West China Hospital Sichuan University

Chengdu, 610093, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 310009, China

RECRUITING

Ningbo medical center lihuili hospital

Ningbo, 315041, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, 200233, China

RECRUITING

RHEUMA s r o

Břeclav, 690 02, Czechia

RECRUITING

L K N Arthrocentrum

Hlučín, 748 01, Czechia

RECRUITING

Revmatologicka ambulance

Karvina Frystat, 733 01, Czechia

RECRUITING

Pratia Czech A S

Pardubice, 53002, Czechia

RECRUITING

Clintrial s r o

Prague, 100 00, Czechia

RECRUITING

Medical Plus Research S R O

Uherské Hradiště, 68601, Czechia

RECRUITING

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

RECRUITING

Charite Universitaetsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Rheumatologische Schwerpunktpraxis

Berlin, 10777, Germany

RECRUITING

Praxis Mario Sutowicz

Cottbus, 3042, Germany

RECRUITING

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

RECRUITING

CAIR Heidelberg

Heidelberg, 69121, Germany

RECRUITING

Gemeinschaftspraxis Dres. Quist

Mainz, 55128, Germany

RECRUITING

Hautarztpraxis Mortazawi

Remscheid, 42897, Germany

RECRUITING

Hautarztpraxis

Witten, 58453, Germany

RECRUITING

Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

Budapest, 1023, Hungary

RECRUITING

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

RECRUITING

Qualiclinic Kft

Budapest, 1134, Hungary

RECRUITING

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700, Hungary

RECRUITING

Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, 6800, Hungary

RECRUITING

Complex Rendelo Med Zrt

Székesfehérvár, 8000, Hungary

RECRUITING

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, 8200, Hungary

RECRUITING

Tokyo Metropolitan Tama Medical Center

Fuchū, 183 8524, Japan

RECRUITING

Imamura General Hospital

Kagoshima, 890-0064, Japan

RECRUITING

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, 807-8556, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, 545 8586, Japan

RECRUITING

Sanuki Municipal Hospital

Sanuki, 769-2393, Japan

RECRUITING

Tokito Clinic Rheumatology and Orthopaedic Surgery

Shimonoseki, 752 0976, Japan

RECRUITING

Nzoz Osteo Medic

Bialystok, 15 351, Poland

RECRUITING

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85 168, Poland

RECRUITING

Centrum Kliniczno Badawcze

Elblag, 82-300, Poland

RECRUITING

Malopolskie Badania Kliniczne Sp z o o

Krakow, 30-002, Poland

RECRUITING

Pratia MCM Krakow

Krakow, 30-727, Poland

RECRUITING

ETG Lublin

Lublin, 20 412, Poland

RECRUITING

NZOZ Lecznica MAK MED S C

Nadarzyn, 05-830, Poland

RECRUITING

Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A

Olsztyn, 10 117, Poland

RECRUITING

MICS Centrum Medyczne Torun

Torun, 87-100, Poland

RECRUITING

MICS Centrum Medyczne Warszawa

Warsaw, 00 874, Poland

RECRUITING

MICS Centrum Medyczne Warszawa 1

Warsaw, 00-872, Poland

RECRUITING

Rheuma Medicus Sp z o o

Warsaw, 02 118, Poland

RECRUITING

Centrum Medyczne Reuma Park

Warsaw, 02 665, Poland

RECRUITING

FutureMeds Targowek

Warsaw, 03 291, Poland

RECRUITING

Hosp Univ A Coruna

A Coruña, 15006, Spain

RECRUITING

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hosp. Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hosp. Infanta Luisa

Seville, 41010, Spain

RECRUITING

Hosp. Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): August 2, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (16); DE (9); PL (14); ES (5); CZ (6); CN (10); JP (6); HU (7)