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Completed

NCT Number: NCT03934216

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986165

Drug

Specified Dose on Specified Days

Other names: Deucravacitinib

Placebo

Other

Specified Dose on Specified Days

Primary outcomes

  1. Clinical Remission Response Rate at Week 12

    Time frame: 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 outcomes

  1. Clinical Response Rate at 12 Weeks

    Time frame: 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

  2. Endoscopic Response at Week 12

    Time frame: 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).

  3. Histological Improvement Response Rate at 12 Weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
May 1, 2019
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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