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.
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Global Outcome Measure: Percentage of Participants With Clinical Remission at Induction Week 8 (Week I-8)
Timeframe: Induction Week 8 (Week I-8)
US-specific Outcome Measure: Percentage of Participants With Clinical Remission at Maintenance Week 44
Timeframe: Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Number of Participants With AEs Leading to Discontinuation of Study Intervention
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 40 (Study Week 48)
Global and US-specific Outcome Measures: Number of Participants With AEs of Special Interest (AESI)
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Number of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Number of Participants With Abnormalities in Clinical Laboratory Parameters: Chemistry
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Number of Participants With Reactions Temporally Associated With Intravenous (IV) Infusion (Induction Period) and Subcutaneous (SC) Injection-Site Reactions (Maintenance Period)
Timeframe: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)
Global and US-specific Outcome Measures: Serum Ustekinumab Concentrations
Timeframe: Induction Period: Week 0 (Pre-infusion), Week I-0 (1-hour post infusion), Week I-3, Week I-6, and Week I-8; Maintenance Period: Week M-4, Week M-8, Week M-12, Week M-16, Week M-24, Week M-32, Week M-36 and Week M-44