Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

Official Title
-----------------
Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: rhuMAb Beta7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe ulcerative colitis outpatient Disease duration at time of screening of >/= 12 weeks Exclusion Criteria: Extensive colonic resection or subtotal or total colectomy Presence of an ileostomy or colostomy Moderate to severe anemia A history or evidence of colonic mucosal dysplasia Pregnant or lactating Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block Poorly controlled diabetes Impaired renal function Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV) Positive screening test for latent mycobacterium tuberculosis (TB) infection Demyelinating disease Received any investigational treatment within 12 weeks prior to initiation of study treatment Previous exposure to rhuMAb Beta7

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhuMAb Beta7<br> | Drug: rhuMAb Beta7<br>* Repeating subcutaneous injection<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Repeating subcutaneous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point |  | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1 |  | Week 6 and Week 10 | 
| Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point |  | Week 6 | 
| Proportion of patients with endoscopic score and rectal bleeding score of 0 |  | Week 6 and Week 10 |