Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

Key facts

Study ID

NCT01466374

Run by

Bristol-Myers Squibb

People needed

121

Starts

2011-12-01

Expected to finish

2014-12-01

Last updated by the study team

2015-10-12

Who can join

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

You may qualify if…

• Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
• 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)

You may not qualify if…

• Ulcerative colitis (UC) or indeterminate colitis
• Short bowel syndrome
• Known stricture or noninflammatory stenosis leading to symptoms of obstruction
• Current stoma or current need for colostomy or ileostomy

Where it is running

• 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

Full record on ClinicalTrials.gov

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