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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03934216




Registration number
NCT03934216
Ethics application status
Date submitted
30/04/2019
Date registered
1/05/2019
Date last updated
6/03/2024

Titles & IDs
Public title
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
2018-004694-27
Secondary ID [2] 0 0
IM011-024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Other interventions - Placebo

Experimental: BMS-986165 -

Placebo comparator: Placebo -


Treatment: Drugs: BMS-986165
Specified Dose on Specified Days

Other interventions: Placebo
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Remission Response Rate at Week 12
Timepoint [1] 0 0
From first dose to 12 weeks.
Secondary outcome [1] 0 0
Clinical Response Rate at 12 Weeks
Timepoint [1] 0 0
From first dose to 12 weeks
Secondary outcome [2] 0 0
Endoscopic Response at Week 12
Timepoint [2] 0 0
up to 12 Weeks
Secondary outcome [3] 0 0
Histological Improvement Response Rate at 12 Weeks
Timepoint [3] 0 0
up to 12 Weeks

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com



* Must have active ulcerative colitis (UC) extending = 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
* 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

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2023
Sample size
Target
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Local Institution - 0071 - Bedford Park
Recruitment hospital [3] 0 0
Local Institution - 0108 - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3181 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Georgia
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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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United States of America
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Maryland
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Michigan
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Minnesota
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Nevada
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New York
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Ohio
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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United States of America
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Washington
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Liege
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Czechia
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Hradec Kralove
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Czechia
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Slany
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France
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Montpellier cedex 5
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France
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Pierre Benite Cedex
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France
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Saint-Etienne
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France
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Toulouse cedex 9
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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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Hannover
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Ulm
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Hungary
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Budapest
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Debrecen
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Bologna
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Catanzaro
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Messina
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Padova
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Italy
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Pavia
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Italy
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Roma
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Japan
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Aomori
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hyogo
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Japan
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Kanagawa
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Shiga
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Japan
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Tokyo
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Japan
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Saga
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Daegu
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Incheon
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Seoul
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Poland
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Bydgoszcz
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Lodz
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Nowy Targ
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Piotrkow Trybunalski
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Sopot
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Szczecin
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Tychy
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Warszawa
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Wroclaw
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Russian Federation
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Nizhniy Novgorod
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Novosibirsk
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Russian Federation
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Saratov
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Russian Federation
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Tyumen
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United Kingdom
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Barnsley
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Cambridge
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Glasgow
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London
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/study/NCT03934216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03934216