A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04630028
Phase
PHASE3
Status
Completed

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.

Key Dates

Start date
Mar 17, 2021
Status verified
May 2026
Primary completion
May 8, 2025
Completion
Jun 5, 2025

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Period (I): Ustekinumab
    All participants will receive a single intravenous (IV) administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square \[mg/m\^2\]) or weight-tiered induction dose (milligram per kilogram \[mg/kg\]).
  • Experimental: Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
    Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
  • Experimental: Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
    Participants will receive SC administration of ustekinumab every 12 weeks (q12w) based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.

Primary Outcome Measure

Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit [ Time Frame: Week 8 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Nemours DuPont Hospital for ChildrenWilmingtonDelaware19803-
Children's Center for Digestive Health CareAtlantaGeorgia30342-
Mayo ClinicRochesterMinnesota55905-
Morristown Memorial HospitalMorristownNew Jersey07962-
Levine Childrens at Atrium HealthCharlotteNorth Carolina28207-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Penn State Hershey Children's HospitalHersheyPennsylvania17033-
Cook Childrens Medical CenterFort WorthTexas76104-
Pediatric Specialists Of VirginiaFairfaxVirginia22031-

Find similar trials in Wilmington, DE

By research site
Nemours DuPont Hospital for Children· Wilmington, DEChildren's Center for Digestive Health Care· Atlanta, GAMayo Clinic· Rochester, MNMorristown Memorial Hospital· Morristown, NJLevine Childrens at Atrium Health· Charlotte, NCUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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