Phase 2
Completed N=131
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Source: ClinicalTrials.gov NCT03934216 ↗Enrolled (actual)
131
Serious AEs
19.4%
Results posted
Jul 2022
Primary outcomePrimary: Clinical Remission Response Rate at Week 12 — 14.8; 16.3 Percentage of Participants — p=0.5935
Summary
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Remission Response Rate at Week 12 |
14.8; 16.3 | 0.5935 |
| SECONDARY Clinical Response Rate at 12 Weeks |
37.5; 32.6 | 0.3051 |
| SECONDARY Endoscopic Response at Week 12 |
19.3; 27.9 | 0.8764 |
| SECONDARY Histological Improvement Response Rate at 12 Weeks |
21.6; 16.3 | 0.2235 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03934216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.