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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01336465
First received: April 14, 2011
Last updated: July 7, 2014
Last verified: July 2014

April 14, 2011
July 7, 2014
September 2011
September 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01336465 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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

This Phase II study is a randomized, double-blind, placebo-controlled multicente r study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with mo derate to severe ulcerative colitis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: placebo
    Repeating subcutaneous injection
  • Drug: rhuMAb Beta7
    Repeating subcutaneous injection
  • Experimental: A
    Intervention: Drug: rhuMAb Beta7
  • Placebo Comparator: B
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
June 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Israel,   New Zealand,   Spain,   United Kingdom
 
NCT01336465
ABS4986g, GP27778
Not Provided
Genentech
Genentech
Not Provided
Study Director: Sharon O'Byrne, M.D. Genentech
Genentech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP