Home › Trials › NCT05083182

Evaluating Ustekinumab and Guselkumab for Pediatric Psoriatic Arthritis

A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

PHASE3 · Janssen Research & Development, LLC · NCT05083182

This study is testing whether two medications, ustekinumab and guselkumab, can help children with active juvenile psoriatic arthritis feel better when other treatments haven't worked.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment48 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionsmethotrexate, ustekinumab, guselkumab
Locations50 sites (Los Angeles, California and 49 other locations)
Trial IDNCT05083182 on ClinicalTrials.gov

What this trial studies

This study aims to assess the pharmacokinetics, efficacy, safety, and immunogenicity of two medications, ustekinumab and guselkumab, in children diagnosed with active juvenile psoriatic arthritis. Participants will be evaluated based on their disease activity, specifically targeting those with active symptoms despite prior treatments. The study will involve monitoring the response to these treatments over a defined period to determine their effectiveness in managing the condition.

Who should consider this trial

Good fit: Ideal candidates include pediatric patients diagnosed with juvenile psoriatic arthritis who have active disease and have not responded adequately to previous treatments.

Not a fit: Patients with enthesitis-related arthritis or those who have not been diagnosed with juvenile psoriatic arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for children suffering from juvenile psoriatic arthritis.

How similar studies have performed: Other studies have shown promise in using biologic therapies for juvenile arthritis, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made \>=3 months (that is, 90 days) prior to screening
* Active disease in at least greater than or equal to (\>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
* Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
* Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
* Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
* Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period

Exclusion Criteria:

* Participants with enthesitis-related arthritis (ERA)
* Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis 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

Where this trial is running

Los Angeles, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Arthritis, Juvenile

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.