CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 383 enrolled
Drug / intervention
Vedolizumab 300 mg IV +3 moredrug
Likely dose
Vedolizumab 300 mg IVfrom 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/NCT02611830
NCT02611830Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Takeda·interventional·Posted Nov 23, 2015·Updated May 25, 2022

In Brief

A Phase 3 clinical trial evaluating Vedolizumab 300 mg IV, Placebo IV, and 2 other interventions for Colitis, Ulcerative. Completed, enrolled 383 participants across 174 sites in 31 countries.

Detailed Summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesArgentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Germany, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 23, 2015
Enrollment StartDec 18, 2015
Primary CompletionMay 30, 2018
Study CompletionAug 21, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.6 years ago

Interventions

Vedolizumab 300 mg IVdrug

Vedolizumab intravenous infusion

Placebo IVdrug

Vedolizumab intravenous infusion placebo

Vedolizumab 108 mg SCdrug

Vedolizumab subcutaneous injection

Placebo SCdrug

Vedolizumab subcutaneous injection placebo