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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01336465




Trial ID
NCT01336465
Ethics application status
Date submitted
14/04/2011
Date registered
14/04/2011
Date last updated
10/08/2016

Titles & IDs
Public title
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
GP27778
Secondary ID [2] 0 0
ABS4986g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - rhuMAb Beta7

Experimental: rhuMAb Beta7 -

Placebo Comparator: placebo -


Treatment: Drugs: placebo
Repeating subcutaneous injection

Treatment: Drugs: rhuMAb Beta7
Repeating subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Timepoint [1] 0 0
Week 10
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 6 and Week 10
Secondary outcome [2] 0 0
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
Proportion of patients with endoscopic score and rectal bleeding score of 0
Timepoint [3] 0 0
Week 6 and Week 10

Eligibility
Key inclusion criteria
- Diagnosis of moderate to severe ulcerative colitis outpatient

- Disease duration at time of screening of >/= 12 weeks
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Fitzroy
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
Belgium
State/province [9] 0 0
Bonheiden
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Liège
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Hradec Kralove
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Nachod
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Ostrava - Poruba
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Zlin
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Kiel
Country [22] 0 0
Germany
State/province [22] 0 0
Minden
Country [23] 0 0
Germany
State/province [23] 0 0
Ulm
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Gyor
Country [26] 0 0
Hungary
State/province [26] 0 0
Gyöngyös
Country [27] 0 0
Hungary
State/province [27] 0 0
Mosonmagyaróvár
Country [28] 0 0
Israel
State/province [28] 0 0
Beer Sheva
Country [29] 0 0
Israel
State/province [29] 0 0
Haifa
Country [30] 0 0
Israel
State/province [30] 0 0
Jerusalem
Country [31] 0 0
Israel
State/province [31] 0 0
Ramat Gan
Country [32] 0 0
Israel
State/province [32] 0 0
Tel Aviv
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
New Zealand
State/province [35] 0 0
Dunedin
Country [36] 0 0
New Zealand
State/province [36] 0 0
Takapuna
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Harrow
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01336465
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon O'Byrne, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries