Status:
COMPLETED
A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Juvenile Psoriatic Arthritis
Psoriasis
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO).
Detailed Description
jPsA is a complex, chronic, progressive, debilitating musculoskeletal disease with significant remaining medical need. There is a need for medications which have a similar efficacy profile and a well-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Has poor tolerability of venipuncture or lack of adequate venous access for required blood sampling
- 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
- If currently enrolled in an investigational study, contact the study responsible physician to discuss eligibility for inclusion in study
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05252533
Start Date
May 24 2022
End Date
January 26 2024
Last Update
April 27 2025
Active Locations (10)
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1
Newport Huntington Medical Group
Huntington Beach, California, United States, 92648
2
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60611-2991
4
Michigan Dermatology Institute
Waterford, Michigan, United States, 48328