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

This study is currently recruiting participants.
Verified October 2011 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01336465
First received: April 14, 2011
Last updated: October 28, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Drug: placebo
Drug: rhuMAb Beta7
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients with endoscopic score and rectal bleeding score of 0 [ Time Frame: Week 6 and Week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: rhuMAb Beta7
Repeating subcutaneous injection
Placebo Comparator: B Drug: placebo
Repeating subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336465

Contacts
Contact: Genentech Trial Information Support Line 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 51 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Sharon O'Byrne, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01336465     History of Changes
Other Study ID Numbers: ABS4986g, GP27778
Study First Received: April 14, 2011
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013