Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
NCT ID: NCT03934216
Last Updated: 2024-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2019-07-01
2023-04-04
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
Specified Dose on Specified Days
Interventions
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BMS-986165
Specified Dose on Specified Days
Placebo
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 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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Connecticut Clinical Research Foundation
Bristol, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Local Institution - 0048
New Port Richey, Florida, United States
Local Institution - 0044
Sweetwater, Florida, United States
Local Institution - 0011
Suwanee, Georgia, United States
Local Institution - 0121
Glenview, Illinois, United States
Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
Baton Rouge, Louisiana, United States
Local Institution - 0018
Shreveport, Louisiana, United States
Local Institution - 0047
Chevy Chase, Maryland, United States
Infusion Associates
Grand Rapids, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Local Institution - 0002
Las Vegas, Nevada, United States
Local Institution - 0049
Lake Success, New York, United States
New York University Langone Medical Center
New York, New York, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Local Institution - 0074
Charleston, South Carolina, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Local Institution - 0097
Garland, Texas, United States
Local Institution - 0008
Houston, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Local Institution - 0106
San Antonio, Texas, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States
Local Institution - 0116
Tyler, Texas, United States
Local Institution - 0096
Seattle, Washington, United States
Swedish First Hill Campus
Seattle, Washington, United States
Local Institution - 0122
Vancouver, Washington, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Local Institution - 0071
Bedford Park, South Australia, Australia
Local Institution - 0108
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Local Institution - 0039
Antwerp, , Belgium
Local Institution - 0065
Brussels, , Belgium
Clinique du MontLegia - CHC
Liège, , Belgium
Hepato-Gastroenterology HK
Hradec Králové, , Czechia
Nemocnice Slany
Slaný, , Czechia
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
Saint-Etienne, , France
Local Institution
Toulouse, , France
Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
Berlin, , Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Local Institution - 0070
Kiel, , Germany
Local Institution - 0062
Leipzig, , Germany
Universitatsklinik Ulm
Ulm, , Germany
Magyar Honvedseg-Egeszsegugyi Kozpont
Budapest, , Hungary
Local Institution - 0042
Budapest, , Hungary
Local Institution - 0024
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Bugat Pal Korhaz
Gyöngyös, , Hungary
Local Institution - 0033
Rozzano, Milano, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
Bologna, , Italy
Local Institution - 0005
Catanzaro, , Italy
Clinica Medica Azienda Ospedaliera Universitaria
Messina, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Local Institution - 0027
Pavia, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Local Institution - 0046
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Local Institution - 0078
Kurume, Fukuoka, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki, Gunma, Japan
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, Japan
Local Institution - 0081
Sagamihara-shi, Kanagawa, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Local Institution - 0066
Bunkyo-ku, Tokyo, Japan
Local Institution - 0080
Minato-ku, Tokyo, Japan
Local Institution - 0069
Saga, , Japan
Local Institution - 0091
Bydgoszcz, , Poland
Local Institution - 0013
Bydgoszcz, , Poland
Local Institution - 0100
Lodz, , Poland
Local Institution - 0045
Lodz, , Poland
Local Institution - 0098
Nowy Targ, , Poland
Local Institution - 0094
Piotrkow Trybunalski, , Poland
Local Institution - 0040
Sopot, , Poland
Local Institution - 0053
Szczecin, , Poland
Local Institution - 0014
Tychy, , Poland
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw, , Poland
Local Institution - 0088
Warsaw, , Poland
Local Institution - 0095
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warsaw, , Poland
Local Institution - 0030
Warsaw, , Poland
Local Institution - 0037
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
Nizhny Novgorod, , Russia
Local Institution - 0020
Novosibirsk, , Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Local Institution - 0092
Novosibirsk, , Russia
Local Institution - 0015
Saratov, , Russia
Multidisciplinary Consultative and Diagnostic Center
Tyumen, , Russia
Local Institution - 0064
Daegu, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Barnsley Hospital NHS Foundation Trust
Barnsley, , United Kingdom
Local Institution - 0031
Cambridge, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , 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
FDA Safety Alerts and Recalls
Other Identifiers
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2018-004694-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-024
Identifier Type: -
Identifier Source: org_study_id
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