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 — DRUGThis 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Newport Huntington Medical Group | Huntington Beach | California | 92648 | - |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | - |
| Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital | Chicago | Illinois | 60611-2991 | - |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | - |
| Columbia University Medical Center | New York | New York | 10032 | - |
| Akron Children s Hospital | Akron | Ohio | 44308 | - |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | - |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | - |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | - |
| Pediatric Rheumatology Consultants of Austin | Austin | Texas | 78757 | - |
Find similar trials in Huntington Beach, CA
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Newport Huntington Medical Group· Huntington Beach, CAChildrens Hospital Los Angeles· Los Angeles, CANorthwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital· Chicago, ILMichigan Dermatology Institute· Waterford, MIColumbia University Medical Center· New York, NYAkron Children s Hospital· Akron, OH
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