IRB Number:

08-005557

Trial status:

Open for Enrollment

Phase: III

Why is this study being done?

The main purpose of this study is to find out whether treatment with Vedolizumab is effective and safe in treating Ulcerative Colitis.

Who is eligible to participate?

Patients with active Ulcerative Colitis.

What is involved?

Induction Phase:
The first 375 subjects enrolled into the study will be assigned to Cohort 1. Subjects in this group will receive either Vedolizumab or placebo (inactive salt water). If you are assigned to Cohort 1, you will have a 6 in 10 chance of receiving Vedolizumab. Once Cohort 1 is full, approximately 451 subjects will be assigned to Cohort 2. All subjects in Cohort 2 will receive Vedolizumab.
Maintenance Phase:
The Induction Phase ends at week 6. All subjects will then enter the Maintenance Phase which lasts 46 weeks. The study drug that you will receive in the Maintenance Phase is based on what you received in the Induction Phase and if you got better.

How long is the study?

You will be in the study for 15 months. You may also be contacted by phone for two years after your final dose of the study drug.

Ad approved by IRB 11-6-09.

Who can I contact for additional information?

Margo Marzolf
507-284-5908

Where is the trial located?

• Rochester, MN

Last updated: 12/11/2009