CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 609 enrolled
Drug / intervention
Etrozulimab +1 moredrug
Likely dose
Etrozulimab 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/NCT02100696
NCT02100696Phase 3Completed
CompareCT.gov

Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

Hoffmann-La Roche·interventional·Posted Apr 1, 2014·Updated Aug 13, 2021

In Brief

A Phase 3 clinical trial evaluating Etrozulimab and Placebo for Ulcerative Colitis. Completed, enrolled 609 participants across 184 sites in 24 countries.

Detailed Summary

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 1, 2014
Enrollment StartMay 21, 2014
Primary CompletionApr 16, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 12.3 years ago

Interventions

Etrozulimabdrug

Participants will receive 105 mg etrolizumab administered by SC injection Q4W.

Placebodrug

Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.