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

Bristol-Myers Squibb131 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

131

Conditions

Ulcerative Colitis

Interventions

BMS-986165DRUG

Specified Dose on Specified Days

PlaceboOTHER

Specified Dose on Specified Days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (107)

Outcomes

Primary Outcomes

Clinical Remission Response Rate at Week 12

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

Time frame: From first dose to 12 weeks.

Secondary Outcomes

Clinical Response Rate at 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

Time frame: From first dose to 12 weeks

Endoscopic Response at Week 12

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).

Time frame: up to 12 Weeks

Data from ClinicalTrials.gov

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Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

University of Florida

Gainesville, Florida, 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

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Suwanee, Georgia, United States

Local Institution - 0121

Glenview, Illinois, United States

Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

Local Institution - 0047

Chevy Chase, Maryland, United States

...and 97 more locations