A Study of Ustekinumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

• Status: Not yet recruiting
• Trial end date: 2026-03-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and efficacy of ustekinumab in juvenile psoriatic arthritis (jPsA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made at least 3 months prior to screening

• Active disease in at least 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness

• Inadequate response (at least 1 month) or intolerance to at least 1 non-steroidal anti-inflammatory drug (NSAID)

• Inadequate response (at least 3 months) or intolerance to at least 1 nonbiological disease modifying anti-rheumatic drug (DMARD)

• If using corticosteroids; must be on a stable dose of less than or equal to (<=) 10 milligrams (mg) prednisone equivalent or 0.20 mg per kilograms (kg) per day (whichever is less) for at least 4 weeks before first administration of study intervention. If currently not using corticosteroids, the participant must have not received corticosteroids (intra articular, intramuscular, or intravenous [IV] corticosteroids [including intramuscular corticotropin]) for at least 4 weeks before the first dose administration

Exclusion Criteria:

• Participants with ERA

• Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening

• Have a history of, or ongoing, chronic or recurrent infectious disease

• Has evidence of herpes zoster infection within 8 weeks prior to Week 0

• Have a known history of hepatitis C infection or test positive at screening