CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 359 enrolled
Drug / intervention
Etrolizumab +1 moredrug
Likely dose
Etrolizumab 105 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02165215
NCT02165215Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Jun 17, 2014·Updated Aug 19, 2021

In Brief

A Phase 3 clinical trial evaluating Etrolizumab and Placebo for Colitis, Ulcerative. Completed, enrolled 359 participants across 104 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesBrazil, Canada, Czechia, Denmark, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Slovakia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 17, 2014
Enrollment StartAug 12, 2014
Primary CompletionApr 6, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 12.0 years ago

Interventions

Etrolizumabdrug

Participants will receive 105 mg etrolizumab SC injection Q4W.

Placebodrug

Participants will receive placebo (matched to etrolizumab) SC injection Q4W.