Trials / Active Not Recruiting
Active Not RecruitingNCT05092269
A Long-term Extension Study of Ustekinumab in Pediatric Participants
A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 159 (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 collect long-term safety data of subcutaneous (SC) ustekinumab
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ustekinumab | Ustekinumab will be administered as a SC injection. |
Timeline
- Start date
- 2021-10-18
- Primary completion
- 2027-09-29
- Completion
- 2028-03-15
- First posted
- 2021-10-25
- Last updated
- 2026-04-13
Locations
48 sites across 13 countries: United States, Argentina, Belgium, France, Germany, Hungary, Israel, Italy, Japan, Poland, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05092269. Inclusion in this directory is not an endorsement.