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

August 10, 2016 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Fitzroy, Victoria, Australia, 3065
      • Melbourne, Victoria, Australia, 3181
      • Parkville, Victoria, Australia, 3050
  • Belgium
      • Bonheiden, Belgium, 2820
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, V6Z 1Y6
      • Edmonton, Alberta, Canada, T6G 2X8
    • Ontario
      • London, Ontario, Canada, N6A 5W9
      • Woodbridge, Ontario, Canada, L4L 4Y7
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 12
      • Nachod, Czech Republic, 547 01
      • Ostrava - Poruba, Czech Republic, 708 52
      • Zlin, Czech Republic, 762 75
  • Germany
      • Berlin, Germany, 13353
      • Hannover, Germany, 30625
      • Kiel, Germany, 24105
      • Minden, Germany, 32423
      • Ulm, Germany, 89081
  • Hungary
      • Budapest, Hungary, 1136
      • Budapest, Hungary, 1073
      • Gyor, Hungary, 9024
      • Gyöngyös, Hungary, 3200
      • Mosonmagyaróvár, Hungary, 9200
  • Israel
      • Beer Sheva, Israel, 84105
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91031
      • Ramat Gan, Israel, 52621
      • Tel Aviv, Israel, 64239
  • New Zealand
      • Auckland, New Zealand, 1023
      • Auckland, New Zealand, 1640
      • Christchurch, New Zealand, 8011
      • Dunedin, New Zealand, 9054
      • Takapuna, New Zealand, 0620
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
      • London, United Kingdom, SW10 9NH
      • London, United Kingdom, N6A 4L6
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
  • United States
    • California
      • San Diego, California, United States, 92103
    • Florida
      • Gainesville, Florida, United States, 32610
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0682
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • Great Neck, New York, United States, 11021
    • Ohio
      • Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo
Repeating subcutaneous injection
EXPERIMENTAL: rhuMAb Beta7
Drug: rhuMAb Beta7
Repeating subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Time Frame: Week 10
Week 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1
Time Frame: Week 6 and Week 10
Week 6 and Week 10
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Time Frame: Week 6
Week 6
Proportion of patients with endoscopic score and rectal bleeding score of 0
Time Frame: Week 6 and Week 10
Week 6 and Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Sharon O'Byrne, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (ESTIMATE)

April 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABS4986g
  • GP27778 (OTHER: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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