Trials / Recruiting
RecruitingNCT05923073
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- 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 clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Guselkumab | Guselkumab will be administered subcutaneously. |
| DRUG | Guselkumab | Guselkumab will be administered intravenously. |
Timeline
- Start date
- 2024-03-13
- Primary completion
- 2027-10-27
- Completion
- 2028-07-12
- First posted
- 2023-06-28
- Last updated
- 2026-04-13
Locations
84 sites across 17 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05923073. Inclusion in this directory is not an endorsement.