Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)
2 other identifiers
interventional
305
13 countries
73
Brief Summary
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Typical duration for phase_2
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 25, 2015
June 1, 2015
1.8 years
February 10, 2011
June 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
End of Induction [Week 11, Induction Period-78 (IP-78)]
Secondary Outcomes (4)
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
IP-78 (Week 11)
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo
IP-78 (Week 11)
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
IP-78 (Week 11)
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo
Baseline (IP-1, Week 1) and IP-78 (Week 11)
Study Arms (5)
Cohort 1: Induction
EXPERIMENTALPlacebo or Anti-IP-10 Antibody
Cohort 2: Induction
EXPERIMENTALPlacebo or Anti-IP-10 Antibody
Cohort 3: Induction
EXPERIMENTALPlacebo or Anti-IP-10 Antibody
Maintenance
EXPERIMENTALPlacebo or Anti-IP-10 Antibody
Open Label
OTHERInterventions
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
- 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)
You may not qualify if:
- Diagnosis of Crohn's Disease or Indeterminate Colitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
University Of California, San Diego
La Jolla, California, 92093, United States
Santa Monica Research Institute
Santa Monica, California, 90404, United States
Western States Clinical Research Inc.
Wheat Ridge, Colorado, 80033, United States
University Of Florida
Gainesville, Florida, 32610, United States
Shafran Gasteroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Health Science Research Center
Pratt, Kansas, 67124, United States
University Of Kentucky
Lexington, Kentucky, 40536, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Gastroenterology Research Of New Orleans
Hammond, Louisiana, 70403, United States
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, 20815, United States
Minnesota Gastroenterology, Pa
Plymouth, Minnesota, 55446, United States
Westglen Gastrointestinal Consultants
Lee's Summit, Missouri, 64064, United States
Long Island Clinical Research Assoc., Llp
Great Neck, New York, 11021, United States
Mount Sinai School Of Medicine
New York, New York, 10029, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, 28207, United States
Consultants For Clinical Research
Cincinnati, Ohio, 45219, United States
Gastroenterology Research Of Lima
Lima, Ohio, 45806, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Gastroenterology Research Of San Antonio
San Antonio, Texas, 78229, United States
Gastroenterology Research Of Tyler (Gerty)
Tyler, Texas, 75701, United States
Local Institution
Garran, Australian Capital Territory, 2605, Australia
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Concord, New South Wales, 2139, Australia
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Herston, Queensland, 4029, Australia
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Parkville, Victoria, 3050, Australia
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South Brisbane, Victoria, 4101, Australia
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Fremantle, Western Australia, 6959, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Bonheiden, 2820, Belgium
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Edegem, 2650, Belgium
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Leuven, B-3000, Belgium
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Goiânia, Goiás, 74535, Brazil
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Rio de Janeiro, Rio de Janeiro, 21941, Brazil
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Botucatu, São Paulo, 18618, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Kingston, Ontario, K7L 5G2, Canada
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Vaughan, Ontario, L4L 4Y7, Canada
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Clichy, 92110, France
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Lille, 59037, France
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Nice, 06200, France
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Pessac, 33600, France
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Vandœuvre-lès-Nancy, 54511, France
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Hamburg, 20148, Germany
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Kiel, 24105, Germany
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Münster, 48149, Germany
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Münster, 48155, Germany
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Budapest, 1088, Hungary
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Budapest, 1115, Hungary
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Debrecen, 4012, Hungary
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Szeged, 6720, Hungary
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Padua, 35128, Italy
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Roma, 00152, Italy
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San Donato Milanese (mi), 20097, Italy
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San Giovanni Rotondo (fg), 71013, Italy
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Guadalajara, Jalisco, 44340, Mexico
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Guadalajara, Jalisco, 45040, Mexico
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Mexico City, Mexico City, 14080, Mexico
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Mexico, D. F., Mexico City, 06726, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Veracruz, Veracruz, 91900, Mexico
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Amsterdam, 1081 HV, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Rzeszów, 35-068, Poland
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Sosnowiec, 41-200, Poland
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Warsaw, 02-507, Poland
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Warsaw, 03-580, Poland
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Overport, KwaZulu-Natal, 4091, South Africa
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Claremont, Western Cape, 7708, South Africa
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Panorama, Western Cape, 7506, South Africa
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Paarl, 7646, South Africa
Related Publications (1)
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.
PMID: 26721935DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2014
Last Updated
June 25, 2015
Record last verified: 2015-06