Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
NCT ID: NCT01466374
Last Updated: 2015-10-12
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
121 participants
INTERVENTIONAL
2011-12-31
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
Placebo
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Cohort 2: Induction
Anti-IP-10 Antibody
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Cohort 3: Induction
Anti-IP-10 Antibody
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Cohort 1: Maintenance
Placebo
Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
Cohort 2: Maintenance
Anti-IP-10 Antibody
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Cohort 3: Maintenance
Anti-IP-10 Antibody
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Cohort 1: Open Label
Anti-IP-10 Antibody
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Interventions
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Placebo
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
* In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)
Exclusion Criteria
* Short bowel syndrome
* Known stricture or noninflammatory stenosis leading to symptoms of obstruction
* Current stoma or current need for colostomy or ileostomy
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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Southern California Medical Gastroenterology Group
Santa Monica, California, United States
Shafran Gasteroenterology Center
Winter Park, Florida, United States
Gastroenterology Research Of New Orleans
Hammond, Louisiana, United States
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, United States
Midwest Center For Clinical Research
Lees Summit, Missouri, United States
Nyu Langone Long Island Clinical Research Associates
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
Consultants For Clinical Research
Cincinnati, Ohio, United States
Gastroenterology Research Of San Antonio
San Antonio, Texas, United States
Local Institution
Brussels, , Belgium
Local Institution
Leuven, , Belgium
Local Institution
Amiens, , France
Local Institution
Clichy, , France
Local Institution
Nice, , France
Local Institution
Pessac, , France
Local Institution
Rouen, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Budapest, , Hungary
Local Institution
Budapest, , Hungary
Local Institution
Budapest, , Hungary
Local Institution
Debrecen, , Hungary
Local Institution
Haifa, , Israel
Local Institution
Kfar Saba, , Israel
Local Institution
Nazareth, , Israel
Local Institution
Krakow, , Poland
Local Institution
Rzeszów, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Warsaw, , Poland
University Of Puerto Rico School Of Medicine
San Juan, , Puerto Rico
Local Institution
Overport, KwaZulu-Natal, South Africa
Local Institution
Claremont, Western Cape, South Africa
Local Institution
Panorama, Western Cape, South Africa
Countries
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References
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Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-gamma-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.
Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-002981-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM129-008
Identifier Type: -
Identifier Source: org_study_id
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