Trials / Completed
CompletedNCT01461317
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etrolizumab | Participants will receive etrolizumab at a dose of 100 mg. |
Timeline
- Start date
- 2011-11-29
- Primary completion
- 2016-08-07
- Completion
- 2016-08-07
- First posted
- 2011-10-28
- Last updated
- 2020-02-10
Locations
40 sites across 11 countries: United States, Australia, Belgium, Canada, Czechia, Germany, Hungary, Israel, New Zealand, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01461317. Inclusion in this directory is not an endorsement.