NCT04673357

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

A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Ustekinumab	Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.
DRUG	Placebo	Matching placebo will be administered as SC injection.

Timeline

• Start date: 2021-04-06
• Primary completion: 2024-11-28
• Completion: 2025-03-03
• First posted: 2020-12-17
• Last updated: 2025-11-28

Locations

53 sites across 9 countries: United States, Belgium, Germany, Hungary, Israel, Japan, Poland, Russia, United Kingdom

Regulatory

• FDA-regulated drug study