Clinical trial
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and…
NCT02407236 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT02407236 |
|---|---|
| Title | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis |
| Official title | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis |
| Acronym | UNIFI |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative, Inflammatory Bowel Diseases |
| Intervention type | Drug |
| Interventions | Placebo IV, Placebo SC, Ustekinumab IV, Ustekinumab SC |
| Enrollment | 961 |
| Start date | Jul 10, 2015 |
| Primary completion | Aug 10, 2018 |
| Completion | Nov 30, 2021 |
| First posted | Apr 2, 2015 |
| Last update posted | Apr 29, 2025 |
| Countries | Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Japan and 11 more |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: