Trials / Completed
CompletedNCT05029921
A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
A Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 182 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the clinical and endoscopic efficacy and safety of ustekinumab in Chinese participants with moderately to severely active Crohn's disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ustekinumab | Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase. |
Timeline
- Start date
- 2021-12-10
- Primary completion
- 2025-05-18
- Completion
- 2025-05-18
- First posted
- 2021-09-01
- Last updated
- 2025-09-17
Locations
29 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05029921. Inclusion in this directory is not an endorsement.