Status:

RECRUITING

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

Lead Sponsor:

Janssen Research & Development, LLC

Conditions:

Arthritis, Psoriatic

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 s...

Eligibility Criteria

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 (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

Key Trial Info

Start Date :

January 15 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 2 2027

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT07321873

Start Date

January 15 2026

End Date

August 2 2027

Last Update

April 13 2026

Active Locations (40)

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Page 1 of 10 (40 locations)

1

Unity Health-White County Medical Center

Searcy, Arkansas, United States, 72143

2

Newport Huntington Medical Group

Huntington Beach, California, United States, 92648

3

Rheumatology Center of San Diego

San Diego, California, United States, 92128

4

American Research, LLC

Cutler Bay, Florida, United States, 33157