Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
NCT ID: NCT01294410
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2011-03-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1: Induction
Placebo or Anti-IP-10 Antibody
Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Cohort 2: Induction
Placebo or Anti-IP-10 Antibody
Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Cohort 3: Induction
Placebo or Anti-IP-10 Antibody
Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Maintenance
Placebo or Anti-IP-10 Antibody
Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Open Label
Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Interventions
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Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
Eligibility Criteria
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Inclusion Criteria
* Mayo score ≥6 with an endoscopic subscore of ≥2
* Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
Exclusion Criteria
* Diagnosis of UC that is limited to the rectum
* Evidence of fulminant colitis, toxic megacolon, or bowel perforation
* Current need for a colostomy or ileostomy
* Previous total or subtotal colectomy
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of California, San Diego
La Jolla, California, United States
Santa Monica Research Institute
Santa Monica, California, United States
Western States Clinical Research Inc.
Wheat Ridge, Colorado, United States
University Of Florida
Gainesville, Florida, United States
Shafran Gasteroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Health Science Research Center
Pratt, Kansas, United States
University Of Kentucky
Lexington, Kentucky, United States
University Of Louisville
Louisville, Kentucky, United States
Gastroenterology Research Of New Orleans
Hammond, Louisiana, United States
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, United States
Minnesota Gastroenterology, Pa
Plymouth, Minnesota, United States
Westglen Gastrointestinal Consultants
Lee's Summit, Missouri, United States
Long Island Clinical Research Assoc., Llp
Great Neck, New York, United States
Mount Sinai School Of Medicine
New York, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, United States
Consultants For Clinical Research
Cincinnati, Ohio, United States
Gastroenterology Research Of Lima
Lima, Ohio, United States
Pharma Resource
East Providence, Rhode Island, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Gastroenterology Research Of San Antonio
San Antonio, Texas, United States
Gastroenterology Research Of Tyler (Gerty)
Tyler, Texas, United States
Local Institution
Garran, Australian Capital Territory, Australia
Local Institution
Concord, New South Wales, Australia
Local Institution
Herston, Queensland, Australia
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Parkville, Victoria, Australia
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South Brisbane, Victoria, Australia
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Fremantle, Western Australia, Australia
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Graz, , Austria
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Vienna, , Austria
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Bonheiden, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Goiânia, Goiás, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Botucatu, São Paulo, Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Kingston, Ontario, Canada
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Vaughan, Ontario, Canada
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Clichy, , France
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Lille, , France
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Nice, , France
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Pessac, , France
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Vandœuvre-lès-Nancy, , France
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Hamburg, , Germany
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Kiel, , Germany
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Münster, , Germany
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Münster, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Padua, , Italy
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Roma, , Italy
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San Donato Milanese (mi), , Italy
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San Giovanni Rotondo (fg), , Italy
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Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico, D. F., Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Veracruz, Veracruz, Mexico
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Rzeszów, , Poland
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Sosnowiec, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Overport, KwaZulu-Natal, South Africa
Local Institution
Claremont, Western Cape, South Africa
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Panorama, Western Cape, South Africa
Local Institution
Paarl, , South Africa
Countries
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References
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Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-022506-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM129-005
Identifier Type: -
Identifier Source: org_study_id
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