IRB Number:

08-006004

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The purpose of this study is to investigate the safety and tolerability of an investigational drug called rhuMAb Beta7 in the treatment of ulcerative colotis (UC) at different dose levels and different routes of administration. The sponsor of the trial is developing rhuMAb Beta7 as a possible treatment to reduce the symptoms associated with UC and Crohn's disease, another inflammatory bowel condition.

Who is Eligible to Participate in the Study?

Patients with ulcerative colitis

Minimum Age:

18

Maximum Age:

70

What is Involved With this Study?

You will be put in one of six groups by chance (as in the flip of a coin) to receive the study drug at one of four dose levels and by one of two routes of administration (either by intravenous [IV] infusion into a vein or by subcutaneous [SC] injection under the skin). Four groups will receive study drug by IV infusion, while two groups will receive study drug by SC injection. Within each group, patients will receive either rhuMAb Beta7 or placebo (a substance that looks like rhuMAb Beta7 but does not contain active drug). This is a randomized study, which means you will be assigned by chance to receive either rhuMAb Beta7 or placebo. In this study, there is a 4 out of 5 (80%) chance that you will receive rhuMAb Beta7.

How long will the Study run?

You will be in the study for approximately two years.

Who can I Contact for Additional Information on this Trial?

Margo Marzolf
507-284-5908

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 03/17/2009