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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04613518
Registration number
NCT04613518
Ethics application status
Date submitted
28/10/2020
Date registered
3/11/2020
Date last updated
19/04/2024
Titles & IDs
Public title
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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2019-004878-26
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Secondary ID [2]
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IM011-127
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Other interventions - Placebo Comparator
Experimental: BMS-986165 -
Placebo Comparator: Placebo -
Experimental: Open label Extension, BMS-986165 -
Treatment: Drugs: BMS-986165
Specified Dose on Specified Days
Other interventions: Placebo Comparator
Specified Dose on Specified Days
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants in clinical response
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Assessment method [1]
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Timepoint [1]
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At Week 12
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Secondary outcome [1]
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Number of adverse events (AEs)
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 56
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/11/2023
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Sample size
Target
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Accrual to date
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Final
38
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - 0005 - Sydney
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Recruitment hospital [2]
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Local Institution - 0002 - Camberwell
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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3142 - Camberwell
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Illinois
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United States of America
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Louisiana
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
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Canada
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Alberta
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Canada
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Ontario
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Kiel
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Netherlands
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Noord-Holland
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Poland
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Mazowieckie
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Poland
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Bydgoszcz
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Poland
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Warsaw
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Puerto Rico
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San Juan
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United Kingdom
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England
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Country [20]
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United Kingdom
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State/province [20]
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04613518
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04613518
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