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

Фаза 3 Завершено NCT04673357

Кратко

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

US-specific Outcome Measure: Percentage of Participants With Clinical Remission at Maintenance Week 44

Maintenance Week 44 (Study Week 52) · Percentage of participants

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

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• A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
• A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severe — Janssen Research & Development, LLC
• A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
• Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
• A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Par — Pfizer

Все исследования