Trials / Completed
CompletedNCT04630028
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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 Ulcerative Colitis
- Status
- Completed
- 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: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ustekinumab Dose Based on BSA and Body Weight | As per BSA and body weight Ustekinumab will be administered SC and IV. |
| DRUG | Matching Placebo | Placebo will be administered subcutaneously. |
Timeline
- Start date
- 2021-03-17
- Primary completion
- 2025-05-08
- Completion
- 2025-06-05
- First posted
- 2020-11-16
- Last updated
- 2025-07-18
Locations
58 sites across 9 countries: United States, Belgium, Germany, Hungary, Israel, Japan, Poland, Russia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04630028. Inclusion in this directory is not an endorsement.