NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (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 guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Guselkumab Subcutaneous	Guselkumab will be administered subcutaneously.
DRUG	Guselkumab Intravenous	Guselkumab will be administered intravenously.

Timeline

• Start date: 2024-01-19
• Primary completion: 2028-05-22
• Completion: 2028-08-14
• First posted: 2024-02-15
• Last updated: 2026-04-13

Locations

61 sites across 13 countries: United States, Australia, Belgium, China, Denmark, France, Italy, Japan, Norway, Poland, Portugal, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study