Recruiting
Phase 2

JNJ-88545223

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07321873

Conditions

Arthritis, Psoriatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-88545223

Placebo

Study Details

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

Study ID

NCT07321873

Start date

Jan 15, 2026

Status verified date

Aug, 2026

Completion date

Aug 2, 2027

Anticipated

Primary completion date

Jun 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Arm 1: Placebo

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

experimental: Arm 2: JNJ-88545223 Dose 1

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

experimental: Arm 3: JNJ-88545223 Dose 2

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

experimental: Arm 4: JNJ-88545223 Dose 3

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

Interventions

JNJ-88545223

JNJ-88545223 will be administered.

Placebo

Placebo will be administered.

Primary outcome measure

  • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Unity Health-White County Medical Center

Recruiting

Searcy, Arkansas, United States, 72143

Newport Huntington Medical Group

Recruiting

Huntington Beach, California, United States, 92648

Rheumatology Center of San Diego

Recruiting

San Diego, California, United States, 92128

American Research, LLC

Recruiting

Cutler Bay, Florida, United States, 33157

Innovation Medical Research Center

Recruiting

Palmetto Bay, Florida, United States, 33157

Integral Rheumatology And Immunology Specialists

Recruiting

Plantation, Florida, United States, 33324

Clinical Research of West Florida

Recruiting

Tampa, Florida, United States, 33606

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Atlanta Research Center for Rheumatology

Recruiting

Marietta, Georgia, United States, 30060

Willow Rheumatology and Wellness PLLC

Recruiting

Willowbrook, Illinois, United States, 60527

Qualmedica Research

Recruiting

Evansville, Indiana, United States, 47715

Albuquerque Rehabilitation and Rheumatology

Recruiting

Albuquerque, New Mexico, United States, 87102

Joint and Muscle Research Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Paramount Medical Research & Consulting

Recruiting

Middleburg Heights, Ohio, United States, 44130

Clinical Research Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Arthritis and Rheumatology Research Institute

Recruiting

Frisco, Texas, United States, 75035

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.