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NCT Number: NCT01336465

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Repeating subcutaneous injection

rhuMAb Beta7

Drug

Repeating subcutaneous injection

Primary outcomes

  1. Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point

    Time frame: Week 10

Secondary outcomes

  1. 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

  2. Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point

    Time frame: Week 6

  3. Proportion of patients with endoscopic score and rectal bleeding score of 0

    Time frame: Week 6 and Week 10

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 18, 2011
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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