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COMPLETEDPHASE2

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

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

NCT01336465•Genentech, Inc.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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
+5 more criteria

Locations (51)

San Diego, California, United States

Gainesville, Florida, United States

Atlanta, Georgia, United States

Chevy Chase, Maryland, United States

Ann Arbor, Michigan, United States

Rochester, Minnesota, United States

Great Neck, New York, United States

Cincinnati, Ohio, United States

Garran, Australian Capital Territory, Australia

Clayton, Victoria, Australia

Key Dates

Start Date

September 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

June 1, 2013

Last Updated

August 12, 2016

Enrollment

124

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

placebo

DRUG

rhuMAb Beta7

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

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Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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