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A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877990
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease Ulcerative Colitis Drug: Deucravacitinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : June 4, 2027
Estimated Study Completion Date : June 4, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Long-Term Extension Rollover Study: Deucravacitinib Drug: Deucravacitinib
Specified dose on specified days


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877990


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04877990    
Other Study ID Numbers: IM011-077
2020-004461-40 ( EudraCT Number )
U1111-1258-3838 ( Registry Identifier: WHO )
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986165
Crohn Colitis
Crohn Disease
Crohn Iliocolitis
 Inflammatory Bowel Disease
Ulcerative Colitis
Deucravacitinib
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes