At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 102 enrolled
Drug / intervention
Vedolizumab Placebo +2 moredrug
Likely dose
Not stated in 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.
A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)
In Brief
A Phase 4 clinical trial evaluating Vedolizumab Placebo, Ciprofloxacin, and 1 other intervention for Pouchitis. Completed, enrolled 102 participants across 34 sites in 9 countries.
Detailed Summary
The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPouchitis
CountriesBelgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartOct 2016
Primary CompletionJun 2020
Study CompletionFeb 2021
TodayJul 2026
First PostedJun 3, 2016
Enrollment StartOct 12, 2016
Primary CompletionJun 11, 2020
Study CompletionFeb 2, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.1 years ago
Interventions
Vedolizumab Placebodrug
Vedolizumab placebo-matching IV infusion
Ciprofloxacindrug
Ciprofloxacin tablets
Vedolizumabdrug
Vedolizumab IV infusion