A Phase III, Randomized, Placebo-Controlled, Blinided Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN002) in Patients with Moderate to Severe Ulcerative Colitis (GEMINI I)

Category: Ulcerative Colitis, Moderate to severe

Date Posted: 2009-09-08

	Principle Investigator: Daniel Geenen, MD 414-908-6630 Site Address: Wisconsin Center for Advanced Research 2801 W. Kinnickinnic River Parkway Suite 1030 Milwaukee, Wisconsin 53215 United States

A phase III, randomized clinical trial evaluating the clinical efficacy and safety of vedolizumab (MLN0002) in patients with moderate to severly active ulcerative colitis who have had an inadequate response or intolerance to a prior conventional therapy.

This research study is testing the effect of an investigational drug, vedolizumab, in adults with moderate to severe ulcerative colitis.  In this one-year study, patients will either receive vedolizumab or placebo by IV.  Subjects may be eligible to continue to receive open label therapy with vedolizumab for up to two additional years following their participation in the placebo controlled study (GEMINI I).  Subjects will be asked to come to the clinic approximately monthly for study visits.  This study is recruiting approximately 826 subjects. 

Potential side effects may include hypersensitivity reactions (allergic response to the study drug) and infection.  As with any investigational drug, additional side effects may be possible.  You should speak to a doctor who is participating in the study to receive a full description of the potential side effects.

Millennium Pharmaceuticals is the sponsor of this study.