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

Genentech

Status and phase

Completed

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: rhuMAb Beta7

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01336465

GP27778 (Other Identifier)

ABS4986g

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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