Trials / Completed
CompletedNCT02165215
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 359 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etrolizumab | Participants will receive 105 mg etrolizumab SC injection Q4W. |
| DRUG | Placebo | Participants will receive placebo (matched to etrolizumab) SC injection Q4W. |
Timeline
- Start date
- 2014-08-12
- Primary completion
- 2020-04-06
- Completion
- 2020-04-06
- First posted
- 2014-06-17
- Last updated
- 2021-08-19
- Results posted
- 2021-06-15
Locations
104 sites across 15 countries: United States, Brazil, Canada, Czechia, Denmark, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Slovakia, South Africa, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02165215. Inclusion in this directory is not an endorsement.