Summary

Eligibility
for people ages 5-17 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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

Official Title

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)

Keywords

Arthritis, Juvenile, Arthritis, Psoriatic Arthritis, Juvenile Arthritis, Ustekinumab, Guselkumab

Eligibility

You can join if…

Open to people ages 5-17

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA accepting new patients
    Los Angeles California 90095-3075 United States
  • Childrens Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05083182
Phase
Phase 3 Arthritis Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated