Active, Not Recruiting
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis - IM011-024
Updated: 23 February, 2023 | ClinicalTrials.gov
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Trial Details
Phase
Gender(s)
Age Range
Active, Not Recruiting
Treatment Options
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit - Must have documented diagnosis of UC of at least 3 months' duration prior to screening - Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2 Exclusion Criteria: - 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 Other protocol-defined inclusion/exclusion criteria apply
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