For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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
  2. 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
  3. 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
  4. Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
  5. Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
  6. 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

Exclusion Criteria:

  1. Participants with enthesitis-related arthritis (ERA)
  2. Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
  3. Have a history of, or ongoing, chronic or recurrent infectious disease
  4. Has evidence of herpes zoster infection within 8 weeks prior to Week 0
  5. Have a known history of hepatitis C infection or test positive at screening
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 844-434-4210Email iconEmail Study Center

Study Details


Contition

Arthritis, Juvenile

Age

5+

Phase

PHASE3

Participants Needed

60

Est. Completion Date

Aug 9, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Janssen Research & Development, LLC

ClinicalTrials.gov NCT Identifier

NCT05083182

Study Number

CNTO1275JPA3001

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