A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Phase 3
Completed
NCT04673357
| Condition | Crohn Disease |
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| Phase | Phase 3 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Completed |
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| Enrollment | 101 participants |
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| Interventions | Ustekinumab |
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| Start date | Apr 6, 2021 |
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| Completion date | Nov 28, 2024 |
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| Results posted | Jul 30, 2026 |
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Summary
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.
Global Outcome Measure: Percentage of Participants With Clinical Remission at Induction Week 8 (Week I-8)
Induction Week 8 (Week I-8) · Percentage of participants
| Induction Period: Ustekinumab Intravenous (IV) | 46.5 Percentage of participants |
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US-specific Outcome Measure: Percentage of Participants With Clinical Remission at Maintenance Week 44
Maintenance Week 44 (Study Week 52) · Percentage of participants
| Maintenance Period: Ustekinumab SC Every 8 Weeks (q8w) | 48.8 Percentage of participants |
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| Maintenance Period: Ustekinumab SC Every 12 Weeks (q12w) | 59.1 Percentage of participants |
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Global and US-specific Outcome Measures: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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) · Participants
| Induction Period: Ustekinumab Intravenous (IV) | 63 Participants |
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| Maintenance Period: Ustekinumab SC Every 8 Weeks (q8w) | 40 Participants |
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| Maintenance Period: Ustekinumab SC Every 12 Weeks (q12w) | 44 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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