Clinical trial NCT01336465: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
timeFrame: Week 10
Secondary outcomes:
measure: 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
timeFrame: Week 6 and Week 10
measure: Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
timeFrame: Week 6
measure: Proportion of patients with endoscopic score and rectal bleeding score of 0
timeFrame: Week 6 and Week 10
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chevy Chase
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Great Neck
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Garran
country: Australia
state: Australian Capital Territory
city: Clayton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Bonheiden
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Woodbridge
country: Canada
state: Ontario
city: Hradec Kralove
country: Czech Republic
city: Nachod
country: Czech Republic
city: Ostrava - Poruba
country: Czech Republic
city: Zlin
country: Czech Republic
city: Berlin
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Minden
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Gyöngyös
country: Hungary
city: Mosonmagyaróvár
country: Hungary
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Takapuna
country: New Zealand
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Harrow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Genentech, Inc.
name: Sharon O'Byrne, M.D.
role: STUDY_DIRECTOR
References:
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.