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NCT Number: NCT04613518

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0005, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
  • Moderately to severely active UC as assessed by the modified Mayo score
  • Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors[SA1]
  • Documentation of prior treatment with corticosteroids for ≥ 4 weeks
  • Males and females must agree to follow specific methods of contraception, if applicable

Exclusion criteria

  • Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
  • Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
  • History or evidence of any extensive colonic resection, or subtotal or total colectomy
  • Women who are pregnant or breastfeeding
  • Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986165

Drug

Specified Dose on Specified Days

Placebo Comparator

Other

Specified Dose on Specified Days

Primary outcomes

  1. Percentage of Participants in Clinical Response at Week 12

    Time frame: At week 12

    Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment)

    • 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

    Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score.

    The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components:

    • Stool frequency (SF) subscore (0 to 3)
    • Rectal bleeding (RB) subscore (0 to 3)
    • Endoscopic (ES) subscore (0 to 3)

  2. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

  3. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

    An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

  4. Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

    Time frame: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

  5. Number of Participants Experiencing Adverse Events of Special Interest (AEIs)

    Time frame: From first dose to 52 weeks after first dose

    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.

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, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2020
Registry last updated
Jul 12, 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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