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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/NCT04877990




Registration number
NCT04877990
Ethics application status
Date submitted
4/05/2021
Date registered
7/05/2021
Date last updated
4/10/2023

Titles & IDs
Public title
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
Scientific title
An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
2020-004461-40
Secondary ID [2] 0 0
IM011-077
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib

Experimental: Long-Term Extension Rollover Study: Deucravacitinib -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adverse events (AEs)
Timepoint [1] 0 0
Up to Week 292
Primary outcome [2] 0 0
Number of serious adverse events (SAEs)
Timepoint [2] 0 0
Up to Week 292
Primary outcome [3] 0 0
Number of AEs leading to study discontinuation
Timepoint [3] 0 0
Up to Week 292
Primary outcome [4] 0 0
Number of clinically significant abnormalities in vital signs: Blood pressure
Timepoint [4] 0 0
Up to Week 292
Primary outcome [5] 0 0
Number of clinically significant abnormalities in vital signs: Heart rate
Timepoint [5] 0 0
Up to Week 292
Primary outcome [6] 0 0
Number of clinically significant abnormalities in vital signs: Temperature
Timepoint [6] 0 0
Up to Week 292
Primary outcome [7] 0 0
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval
Timepoint [7] 0 0
Up to Week 292
Primary outcome [8] 0 0
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval
Timepoint [8] 0 0
Up to Week 292
Primary outcome [9] 0 0
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval
Timepoint [9] 0 0
Up to Week 292
Primary outcome [10] 0 0
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval
Timepoint [10] 0 0
Up to Week 292
Primary outcome [11] 0 0
Number of clinically significant abnormalities in clinical laboratory results: Hematology tests
Timepoint [11] 0 0
Up to Week 292
Primary outcome [12] 0 0
Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test
Timepoint [12] 0 0
Up to Week 292
Primary outcome [13] 0 0
Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests
Timepoint [13] 0 0
Up to Week 292

Eligibility
Key inclusion criteria
• Previously completed open-label extension treatment in one of the parent Crohn's disease
or ulcerative colitis studies
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant or breastfeeding

- Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end
of treatment visit of the parent study or past confirmed colonic dysplasia in the
parent study that has not been eradicated

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
7/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/08/2023
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 0013 - Ballarat
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Mississippi
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
China
State/province [10] 0 0
Guangdong
Country [11] 0 0
Germany
State/province [11] 0 0
Kiel
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Italy
State/province [13] 0 0
Lombardia
Country [14] 0 0
Italy
State/province [14] 0 0
Pavia
Country [15] 0 0
Japan
State/province [15] 0 0
Aomori
Country [16] 0 0
Japan
State/province [16] 0 0
Kanagawa
Country [17] 0 0
Japan
State/province [17] 0 0
Saga
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Netherlands
State/province [19] 0 0
Noord-Holland
Country [20] 0 0
Poland
State/province [20] 0 0
Malopolskie
Country [21] 0 0
Poland
State/province [21] 0 0
Bydgoszcz
Country [22] 0 0
Poland
State/province [22] 0 0
Krakow
Country [23] 0 0
Poland
State/province [23] 0 0
Sopot
Country [24] 0 0
Poland
State/province [24] 0 0
Szczecin
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Poland
State/province [28] 0 0
Slaskie
Country [29] 0 0
Portugal
State/province [29] 0 0
Santa Maria da Feira
Country [30] 0 0
Romania
State/province [30] 0 0
Bucharest
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Irkutsk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Saint-Petersburg
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Morriston

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 evaluate the long-term safety and efficacy of Deucravacitinib
in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for
moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04877990
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/ct2/show/NCT04877990