A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT04613518
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Comparator - Open label Extension, BMS-986165 BMS-986165 - BMS-986165 BMS-986165 -
- Primary Outcome Measures
Name Time Method Percentage of Participants in Clinical Response at Week 12 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)Number of Participants Experiencing Adverse Events of Special Interest (AEIs) 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.
Number of Participants Experiencing Adverse Events (AEs) 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.
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation 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.
Number of Participants Experiencing Serious Adverse Events (SAEs) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Local Institution - 0032
🇺🇸Garland, Texas, United States
Local Institution - 0005
🇦🇺Sydney, New South Wales, Australia
Local Institution - 0025
🇨🇦London, Ontario, Canada
Local Institution - 0003
🇩🇪Berlin, Germany
Local Institution - 0019
🇩🇪Dresden, Germany
Local Institution - 0006
🇩🇪Kiel, Germany
Local Institution - 0009
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0014
🇺🇸San Diego, California, United States
Local Institution - 0029
🇵🇱Bydgoszcz, Poland
Local Institution - 0015
🇺🇸New York, New York, United States
Local Institution - 0013
🇺🇸Cleveland, Ohio, United States
Local Institution - 0033
🇺🇸Southlake, Texas, United States
Local Institution - 0002
🇦🇺Camberwell, Victoria, Australia
Local Institution - 0007
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0008
🇨🇦Vaughan, Ontario, Canada
Local Institution - 0031
🇵🇱Warsaw, Mazowieckie, Poland
Local Institution - 0030
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0028
🇵🇱Bydgoszcz, Poland
Local Institution - 0011
🇵🇷San Juan, Puerto Rico
Local Institution - 0023
🇬🇧London, England, United Kingdom
Local Institution - 0027
🇬🇧Cambridge, United Kingdom
Local Institution - 0039
🇺🇸Lubbock, Texas, United States
Local Institution - 0036
🇺🇸Arlington Heights, Illinois, United States
Local Institution - 0016
🇺🇸Shreveport, Louisiana, United States
Local Institution - 0026
🇺🇸Chapel Hill, North Carolina, United States
Local Institution - 0020
🇺🇸Oklahoma City, Oklahoma, United States