A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04673357
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ustekinumab — DRUG
    Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.
  • Placebo — DRUG
    Matching placebo will be administered as SC injection.

Study Details

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn's disease.

Key Dates

Start date
Apr 6, 2021
Status verified
Nov 2025
Primary completion
Nov 28, 2024
Completion
Mar 3, 2025

Study Design

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

Arms

  • Experimental: Open- Label Ustekinumab Intravenous (IV): Induction Period
    All participants will receive a single 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: Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period
    Participants will receive SC administration of ustekinumab q8w based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at maintenance weeks (Weeks M)-0, M-8, M-16, M-24, M 32, and M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
  • Experimental: Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period
    Participants will receive SC administration of ustekinumab 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

Number of Participants with Clinical Remission at Induction Week 8 [ 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 condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
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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