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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
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Belgium
State/province [18] 0 0
Antwerpen
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels
Country [20] 0 0
Belgium
State/province [20] 0 0
Liege
Country [21] 0 0
Czechia
State/province [21] 0 0
Hradec Kralove
Country [22] 0 0
Czechia
State/province [22] 0 0
Slany
Country [23] 0 0
France
State/province [23] 0 0
Montpellier cedex 5
Country [24] 0 0
France
State/province [24] 0 0
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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Hungary
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Debrecen
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Hungary
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Gyongyos
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Italy
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Milano
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Italy
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Bologna
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Italy
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Catanzaro
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Italy
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Messina
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Italy
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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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Japan
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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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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Poland
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Bydgoszcz
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Poland
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Lodz
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Poland
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Nowy Targ
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Poland
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Piotrkow Trybunalski
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Poland
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Sopot
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Poland
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Szczecin
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Tychy
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Poland
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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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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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03934216