The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
239
Specified dose on specified days
Specified dose on specified days
Percent of Participants Achieving Clinical Remission at Week 12
Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Time frame: 12 weeks after first dose
Percent of Participants Achieving Endoscopic Response at Week 12
Endoscopic Response is defined as \>= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Time frame: 12 weeks after first dose
Percent of Participants Achieving Clinical Response at Week 12
Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score \< 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 0258
Los Angeles, California, United States
Local Institution - 0247
Aurora, Colorado, United States
Local Institution - 0001
Hamden, Connecticut, United States
Local Institution - 0255
Clearwater, Florida, United States
Local Institution - 0259
Jacksonville, Florida, United States
Local Institution - 0261
Jacksonville, Florida, United States
Local Institution - 0276
Largo, Florida, United States
Local Institution - 0232
Miami, Florida, United States
Local Institution - 0162
New Port Richey, Florida, United States
Local Institution - 0201
Orlando, Florida, United States
...and 249 more locations
Time frame: 12 weeks after first dose
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
The Patient Reported Outcomes 2 (PRO2) is a way for patients to report how they're feeling. It focuses on two things: how often they have loose or liquid stools, and how much abdominal pain they have. They keep track of these things every day for a week. Stool frequency is rated on a scale from 0 to 3, with 0 being the normal number of stools per day to 3 which is \>/=5 stools more than normal per day. The pain is rated on a scale from 0 to 3, with 0 being no pain and 3 being severe pain. The scores for these two things are added up to get a total score ranging from 0-6. If the average daily score for abdominal pain is 1 or less, and the average number of loose or liquid stools is 3 or less, then the disease might be in remission. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Time frame: 12 weeks after first dose
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants starting study treatment.
Time frame: 12 weeks after first dose