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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Etrolizumab

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