Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants

Who is this study for? Patients with Juvenile Psoriatic Arthritis
What treatments are being studied? Ustekinumab
Status: Completed
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Newport Huntington Medical Group
Huntington Beach
Childrens Hospital Los Angeles
Los Angeles
Illinois
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Chicago
Michigan
Michigan Dermatology Institute
Waterford
New York
Columbia University Medical Center
New York
Ohio
Akron Children s Hospital
Akron
Cincinnati Children's Hospital Medical Center
Cincinnati
South Carolina
Medical University of South Carolina
Charleston
Texas
Dell Children's Medical Center of Central Texas
Austin
Pediatric Rheumatology Consultants of Austin
Austin
Time Frame
Start Date: 2022-05-24
Completion Date: 2024-01-26
Participants
Target number of participants: 31
Treatments
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.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov