A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05083182
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Arthritis, Juvenile

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Ustekinumab will be administered as subcutaneous injection.
  • Guselkumab — DRUG
    Guselkumab will be administered as subcutaneous injection.

Study Details

The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).

Key Dates

Start date
Aug 30, 2022
Status verified
Jun 2026
Primary completion
Jan 12, 2026
Completion
Jun 24, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Ustekinumab
    Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52. Cohort 1 is closed for further enrollment.
  • Experimental: Cohort 2: Guselkumab
    The dose of guselkumab will be based on the participant's weight. Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator.

Primary Outcome Measure

Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups [ Time Frame: Week 28 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Childrens Hospital Los AngelesLos AngelesCalifornia90027-
UCLALos AngelesCalifornia90095-3075-
Harvard Medical School - Boston Children's HospitalBostonMassachusetts02215-5450-
Northwell HealthNew YorkNew York11040-
Montefiore Medical CenterThe BronxNew York10467-2403-
University of North CarolinaChapel HillNorth Carolina27514-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Legacy Emanuel Medical CenterPortlandOregon97227-
University of UtahSalt Lake CityUtah84132-

Related coverage on Hipa.ai

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By research site
Childrens Hospital Los Angeles· Los Angeles, CAUCLA· Los Angeles, CAHarvard Medical School - Boston Children's Hospital· Boston, MANorthwell Health· New York, NYMontefiore Medical Center· The Bronx, NYUniversity of North Carolina· Chapel Hill, NC

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