Back to resultsEvaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
rhuMAb Beta7
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rhuMAb Beta7
placebo
Arm Description
Outcomes
Primary Outcome Measures
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
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
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Proportion of patients with endoscopic score and rectal bleeding score of 0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01336465
Brief Title
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhuMAb Beta7
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Repeating subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
rhuMAb Beta7
Intervention Description
Repeating subcutaneous injection
Primary Outcome Measure Information:
Title
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
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
Title
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Time Frame
Week 6
Title
Proportion of patients with endoscopic score and rectal bleeding score of 0
Time Frame
Week 6 and Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon O'Byrne, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0682
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liège
ZIP/Postal Code
4000
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
City
Woodbridge
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czech Republic
City
Nachod
ZIP/Postal Code
547 01
Country
Czech Republic
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Minden
ZIP/Postal Code
32423
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Budapest
ZIP/Postal Code
1073
Country
Hungary
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
City
Beer Sheva
ZIP/Postal Code
84105
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
City
Takapuna
ZIP/Postal Code
0620
Country
New Zealand
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
City
London
ZIP/Postal Code
N6A 4L6
Country
United Kingdom
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24814090
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
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