A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis

Part of paid clinical trials in Huntington Beach, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05252533
Phase
PHASE1
Status
Completed

Conditions

  • Arthritis, Juvenile
  • Juvenile Psoriatic Arthritis
  • Psoriasis

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    This study does not provide dosing instructions for ustekinumab but will engage participants who have been treated with ustekinumab by their corresponding HCPs independent of this study.

Study Details

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

Key Dates

Start date
May 24, 2022
Status verified
Apr 2025
Primary completion
Jan 26, 2024
Completion
Jan 26, 2024

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1: Juvenile Psoriatic Arthritis (jPsA)
    Participants (aged greater than or equal to \[\>=\] 5 to less than \[\<\] 18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating health care professional (HCP).
  • Experimental: Cohort 2: Pediatric Psoriasis (PsO)
    Participants (aged \>=6 to \<18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating HCP.

Primary Outcome Measure

Serum Concentration of Ustekinumab [ Time Frame: Up to 16 weeks ]

Locations (10)

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