Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: BMS-986165; Other: Placebo

• Registration Number: NCT03934216
• Lead Sponsor: Bristol-Myers Squibb

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-07-01
• Primary Completion: 2021-06-13
• Results First Submitted: 2022-06-09
• Results First Submitted QC: 2022-06-09
• Results First Posted: 2022-07-06
• Study Completion: 2023-04-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-986165	BMS-986165	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Clinical Remission Response Rate at Week 12	From first dose to 12 weeks.	Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding.; Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability); The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores; Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rate at 12 Weeks	From first dose to 12 weeks	Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore; Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1
Endoscopic Response at Week 12	up to 12 Weeks	Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score.; The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: * Normal (score 0); * patchy obliteration (score 1); * Obliterated (score 2); Bleeding; * None (score 0); * Mucosal (score 1); * Luminal mild (score 2); * Luminal Moderate or severe (score 3); Erosions and Ulcers; * None (score 0); * Erosions ( score 1); * Superficial Ulcer (2); * Deep Ulcer (score 3); A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).
Histological Improvement Response Rate at 12 Weeks	up to 12 Weeks	Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1; Neutrophils \<5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue.; Achieving the following scores for the corresponding grades of the Geboes score: * Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or \< 5% crypts involved), and; * Score of 0 for Grade 4 (crypt destruction: none), and; * Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue); grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease

Trial Locations

Locations (101)

Connecticut Clinical Research Foundation; 🇺🇸 Bristol, Connecticut, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Local Institution - 0048; 🇺🇸 New Port Richey, Florida, United States

Local Institution - 0044; 🇺🇸 Sweetwater, Florida, United States

Local Institution - 0011; 🇺🇸 Suwanee, Georgia, United States

Local Institution - 0121; 🇺🇸 Glenview, Illinois, United States

Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States

Local Institution - 0018; 🇺🇸 Shreveport, Louisiana, United States

Local Institution - 0047; 🇺🇸 Chevy Chase, Maryland, United States

Infusion Associates; 🇺🇸 Grand Rapids, Michigan, United States

Scroll for more (91 remaining)