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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akron Children's Hospital
Coordinator of this site? Confirm its status
AkronUnited StatesUnknown status
Pediatric Rheumatology Consultants of Austin
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Dell Children's Medical Center of Central Texas
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Newport Huntington Medical Group
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesUnknown status
Childrens Hospital Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Columbia University Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Michigan Dermatology Institute
Coordinator of this site? Confirm its status
WaterfordUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.