CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Vedolizumab +1 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.

Search/NCT01177228
NCT01177228Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Millennium Pharmaceuticals, Inc.·interventional·Posted Aug 6, 2010·Updated Jul 18, 2014

In Brief

A Phase 2 clinical trial evaluating Vedolizumab and Placebo for Ulcerative Colitis. Completed, enrolled 47 participants.

Detailed Summary

The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2010
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.9 years ago

Interventions

Vedolizumabdrug

Vedolizumab for intravenous infusion

Placebodrug

Placebo intravenous infusion