drugset / Trial / NCT04630028

A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

NCT04630028

Phase 3 Completed 112 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.

Timeline

Start
2021-03-17
Primary completion
2025-05-08
Completion
2025-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ustekinumab Monoclonal antibody Subcutaneous

Indications