The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Injection, Intravenous (IV), 0 mg, Day One Only, One Day
Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Time frame: At 8 weeks during the Induction Period
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Time frame: At 8 weeks during the Induction Period
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Time frame: Week 8 and Week 12
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
Time frame: Up to Week 12
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Time frame: Week 4, Week 8
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Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
Injection, Intravenous (IV), 600 mg, Day One Only, One Day
Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
Injection, Intravenous (IV), 300 mg, Day One Only, One Day
Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
Injection, Intravenous (IV), 150 mg, Day One Only, One Day
Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
University Of California, San Diego
La Jolla, California, United States
Precision Research Institute, Llc
San Diego, California, United States
South Denver Gastroenterology, Pc
Lone Tree, Colorado, United States
University Of Florida
Gainesville, Florida, United States
University Of Louisville
Louisville, Kentucky, United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Gastro One
Germantown, Tennessee, United States
Local Institution
Vienna, Austria
Local Institution
Calgary, Alberta, Canada
...and 46 more locations
Observed Maximum Concentration (Cmax) of Clazakizumab During the Induction Period
Time frame: Week 0 and Week 4
Area Under the Plasma Concentration-time Curve in One Dosing Interval [AUC(TAU)] of Clazakizumab During the Induction Period
Time frame: Week 0, Week 4, Week 8