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

3상 완료 NCT04673357

요약

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

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

같은 질환의 다른 임상

• 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

전체 임상