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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01336465

Run by

Genentech, Inc.

People needed

124

Starts

2011-09-01

Expected to finish

2013-06-01

Last updated by the study team

2016-08-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of moderate to severe ulcerative colitis outpatient
• Disease duration at time of screening of >/= 12 weeks

You may not qualify if…

• 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

Where it is running

• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Great Neck, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Garran, Australian Capital Territory, Australia
• Study site — Clayton, Victoria, Australia
• Study site — Fitzroy, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Parkville, Victoria, Australia
• Study site — Bonheiden, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Liège, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — London, Ontario, Canada
• Study site — Woodbridge, Ontario, Canada
• Study site — Hradec Králové, Czechia
• Study site — Náchod, Czechia
• Study site — Ostrava - Poruba, Czechia
• Study site — Zlín, Czechia
• Study site — San Diego, California, United States

Full record on ClinicalTrials.gov

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