NCT05252533CompletedPhase 1
A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis
Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
The purpose of the study is to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 16 Feb 2022
- Start date
- May 2022
- Primary completion date
- Jan 2024
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05252533
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 31
- From May 2022 to the primary completion date, Jan 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has any condition that, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Other
- Has poor tolerability of venipuncture or lack of adequate venous access for required blood sampling
- If currently enrolled in an investigational study, contact the study responsible physician to discuss eligibility for inclusion in study
Who the study is looking for
- Greater than or equal to (\>=) 5 to less than (\<) 18 years of age, inclusive, with a diagnosis of juvenile psoriatic arthritis (jPsA) (that is, International League Against Rheumatism \[ILAR\] or Vancouver criteria) by qualified health care professional (HCP)
- \>=6 to \<18 years of age, inclusive, with a diagnosis of pediatric psoriasis (PsO) by a qualified HCP
- Initiated ustekinumab treatment \>=16 weeks prior to enrollment and received 3 or more doses of ustekinumab prior to enrollment
- Parent(s) (preferably both if available or as per local requirements) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in informed consent process
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akron Children's Hospital Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Pediatric Rheumatology Consultants of Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Newport Huntington Medical Group Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Childrens Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Michigan Dermatology Institute Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.