Overview

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