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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT07321873

Run by

Janssen Research & Development, LLC

People needed

240

Starts

2026-01-15

Expected to finish

2027-08-02

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Newport Huntington Medical Group — Huntington Beach, California, United States (enrolling)
• Rheumatology Center of San Diego — San Diego, California, United States (enrolling)
• American Research, LLC — Cutler Bay, Florida, United States (enrolling)
• Innovation Medical Research Center — Palmetto Bay, Florida, United States (enrolling)
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States (enrolling)
• Clinical Research of West Florida — Tampa, Florida, United States (enrolling)
• Conquest Research — Winter Park, Florida, United States (enrolling)
• Atlanta Research Center for Rheumatology — Marietta, Georgia, United States (enrolling)
• Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States (enrolling)
• Qualmedica Research — Evansville, Indiana, United States (enrolling)
• Albuquerque Rehabilitation and Rheumatology — Albuquerque, New Mexico, United States (enrolling)
• Joint and Muscle Research Institute — Charlotte, North Carolina, United States (enrolling)
• Paramount Medical Research & Consulting — Middleburg Heights, Ohio, United States (enrolling)
• Clinical Research Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Arthritis and Rheumatology Research Institute — Frisco, Texas, United States (enrolling)
• Peking University People's Hospital — Beijing, China (enrolling)
• Peking University Third Hospital — Beijing, China (enrolling)
• Beijing Tsinghua Changgung Hospital — Beijing, China (enrolling)
• Xiangya Hospital Central South University — Changsha, China (enrolling)
• Changzhou No 2 Peoples Hospital — Changzhou, China (enrolling)
• West China Hospital Sichuan University — Chengdu, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (enrolling)
• The Second Affiliated Hospital of Zhejiang University — Hangzhou, China (enrolling)
• Ningbo medical center lihuili hospital — Ningbo, China (enrolling)
• Unity Health-White County Medical Center — Searcy, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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