Phase 2
N=131
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03934216 ↗Enrolled (actual)
131
Serious AEs
19.4%
Results posted
Jul 2022
Primary outcome: Primary: Clinical Remission Response Rate at Week 12 — 14.8; 16.3 Percentage of Participants — p=0.5935
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986165 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2021
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 |
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).
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.