Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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

Key facts

Study ID

NCT01294410

Run by

Bristol-Myers Squibb

People needed

305

Starts

2011-03-01

Expected to finish

2014-12-01

Last updated by the study team

2015-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• University Of California, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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