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

第3相 完了 NCT04673357

概要

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

BENITIONS で見る ClinicalTrials.gov の原文を見る

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