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A study in the use of etrolizumab in patients with ulcerative colitis (Eucalyptus)
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
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Autoimmune Disorder -
Inflammatory Bowel Disease (IBD) -
Ulcerative Colitis
- For Medical Professional
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Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 2
Trial Identifier
NCT01336465, ABS4986g, GP27778
Condition
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
Study 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.
Eligibility Criteria
All
≥18 Years & ≤ 75 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com