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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336465
• Other study ID #: ABS4986g
• Secondary ID: GP27778
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2011
• Last updated: August 10, 2016
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• placebo
Repeating subcutaneous injection
• rhuMAb Beta7
Repeating subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  Germany,  Hungary,  Israel,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point		Week 10	No
Secondary	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		Week 6 and Week 10	No
Secondary	Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point		Week 6	No
Secondary	Proportion of patients with endoscopic score and rectal bleeding score of 0		Week 6 and Week 10	No