A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
NCT ID: NCT04613518
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2021-03-15
2023-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165
BMS-986165
Specified Dose on Specified Days
Placebo
Placebo Comparator
Specified Dose on Specified Days
Open label Extension, BMS-986165
BMS-986165
Specified Dose on Specified Days
Interventions
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BMS-986165
Specified Dose on Specified Days
Placebo Comparator
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0014
San Diego, California, United States
Local Institution - 0036
Arlington Heights, Illinois, United States
Local Institution - 0016
Shreveport, Louisiana, United States
Local Institution - 0015
New York, New York, United States
Local Institution - 0026
Chapel Hill, North Carolina, United States
Local Institution - 0013
Cleveland, Ohio, United States
Local Institution - 0020
Oklahoma City, Oklahoma, United States
Local Institution - 0032
Garland, Texas, United States
Local Institution - 0039
Lubbock, Texas, United States
Local Institution - 0033
Southlake, Texas, United States
Local Institution - 0005
Sydney, New South Wales, Australia
Local Institution - 0002
Camberwell, Victoria, Australia
Local Institution - 0007
Edmonton, Alberta, Canada
Local Institution - 0025
London, Ontario, Canada
Local Institution - 0008
Vaughan, Ontario, Canada
Local Institution - 0003
Berlin, , Germany
Local Institution - 0019
Dresden, , Germany
Local Institution - 0006
Kiel, , Germany
Local Institution - 0009
Amsterdam, North Holland, Netherlands
Local Institution - 0031
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0030
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0029
Bydgoszcz, , 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-004878-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1245-2970
Identifier Type: OTHER
Identifier Source: secondary_id
IM011-127
Identifier Type: -
Identifier Source: org_study_id
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