Overview

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