Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis (IM011-024)
- Conditions
- Ulcerative Colitis
- Registration Number
- jRCT2080224801
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 120
-Active UC extending >= 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit -Documented diagnosis of UC of at least 3 months duration prior to screening -Active moderate to severe UC, defined by a modified Mayo score of 5 to 9 points, inclusive (modified Mayo score range = 0 to 9 points), which includes all of the following subscore values: A stool frequency (SF) subscore of >= 2, and A rectal bleeding (RB) subscore >= 1, and An endoscopic (ES) subscore of >= 2 (screening endoscopy)
-Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile]) -Stool positive for C. difficile toxin at screening visit -Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
Study & Design
- Study Type
- Interventional
- Study Design
- Randomized, parallel-group, treatment
- Primary Outcome Measures
Name Time Method Clinical Remission Response Rate at Week 12 Week 12 Calculated using a modified Mayo score with the following:
- Stool Frequency (SF) sub score <= 1, with >= 1 point decrease from baseline
- Rectal Bleeding (RB) sub score = 0
- Endoscopic (ES) sub score <= 1 (modified, excludes friability)
- Secondary Outcome Measures
Name Time Method Clinical Response Rate at 12 Weeks 12 Weeks Percentage of participants with:
- A decrease from baseline in the modified Mayo score of >= 2 points
- A decrease from baseline in the modified Mayo score >= 30%
- A decrease in rectal bleeding(RB) subscore of >= 1 point or absolute RB subscore <= 1Endoscopic Response rate at Week 12 Week 12 Endoscopic subscore <= 1
Endoscopic Remission rate at Week 12 Week 12 Endoscopic subscore of 0
Trial Locations
- Locations (1)
USA/Australia/Belgium/Czechia/France/Germany/Hungary/Italy/Korea/Poland/Russia/UK
Location not specified
USA/Australia/Belgium/Czechia/France/Germany/Hungary/Italy/Korea/Poland/Russia/UK