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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
305
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
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
Time frame: End of Induction [Week 11, Induction Period-78 (IP-78)]
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Time frame: 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
Time frame: IP-78 (Week 11)
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
Time frame: IP-78 (Week 11)
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo
Time frame: Baseline (IP-1, Week 1) and IP-78 (Week 11)
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Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
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
...and 65 more locations