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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

  • Clinicaltrials.gov identifier

    NCT04877990

  • Recruitment Status

    Recruiting

  • First Posted

    May 7, 2021

  • Last update posted

    September 2, 2022

Study Description

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:Crohn Disease
    Ulcerative Colitis
  • Intervention/Treatment: Drug: Deucravacitinib
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 300 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
  • Actual Study Start Date: May 2021
  • Estimated Primary Completion Date: June 2027
  • Estimated Study Completion Date: June 2027

Arms and interventions

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

Outcome Measures

  • 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

  • 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

Contacts

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

United States, Georgia
Local Institution
Suwanee

United States, Louisiana
Louisiana Research Center-Research
Shreveport

United States, Michigan
West Michigan Clinical Research Center
Wyoming

United States, Mississippi
The University of Mississippi Medical Center-Clinical Research and Trials Unit
Jackson

United States, Ohio
Cleveland Clinic-Gastroenterology
Cleveland

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh

United States, Texas
Southern Star Research Institute - Medical Center Office
San Antonio

United States, Virginia
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond

Australia, Victoria
Local Institution - 0013
Ballarat

Brazil, Bahia
Local Institution
Salvador

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Sao Bernardo do Campo

Brazil
Local Institution
Rio de Janeiro

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Hunan
Local Institution
Changsha

China, Shanghai
Local Institution
City

China, Shanghai
Local Institution
Shanghai

Germany
Local Institution - 0012
Kiel

Hungary
Local Institution - 0023
Budapest

Italy, Lombardia
Humanitas
Rozzano

Italy
Fondazione Irccs - Policlinico San Matteo
Pavia

Japan, Chiba
Local Institution
Sakura

Japan, Saga
Local Institution
Saga-shi

Japan, Tokyo
Local Institution - 0026
Bunkyo-ku

Japan, Tokyo
Local Institution - 0044
Minato-ku

Poland
Local Institution
Bydgoszcz

Poland
Local Institution - 0003
Bydgoszcz

Poland
Local Institution
Krakow

Poland
Local Institution
Sopot

Poland
Local Institution
Szczecin

Poland
Local Institution - 0004
Warszawa

Poland
Local Institution
Warszawa

Poland
Local Institution
Wroclaw

Romania
Local Institution
Bucharest

Russian Federation
Local Institution
Irkutsk

Russian Federation
Local Institution
Saint Petersburg

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
Saratov

Spain, Madrid
Local Institution - 0045
Fuenlabrada

United Kingdom
Local Institution
Morriston

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04877990 History of Changes
  • Other Study ID Numbers: IM011-077, 2020-004461-40, U1111-1258-3838
  • First Posted: May 7, 2021 Key Record Dates
  • Last Update Posted: September 2, 2022
  • Last Verified: August 2022
  • 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: Ulcer
    Crohn Disease
    Colitis
    Colitis, Ulcerative
    Inflammatory Bowel Diseases
    Gastroenteritis
    Gastrointestinal Diseases
    Digestive System Diseases
    Intestinal Diseases
    Colonic Diseases
    Pathologic Processes