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

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:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

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 ]


Enrollment:	124
Study Start Date:	September 2011
Study Completion Date:	June 2013
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: rhuMAb Beta7	Drug: rhuMAb Beta7 Repeating subcutaneous injection
Placebo Comparator: placebo	Drug: placebo Repeating subcutaneous injection

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 51 Study Locations

Sponsors and Collaborators

Genentech, Inc.

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014 Jul 26;384(9940):309-18. doi: 10.1016/S0140-6736(14)60661-9. Epub 2014 May 9.


Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT01336465 History of Changes
Other Study ID Numbers:	ABS4986g GP27778
Study First Received:	April 14, 2011
Last Updated:	August 10, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 26, 2016