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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Deucravacitinib

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Australia
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Local Institution - 0013
• Canada
  • Ontario
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Local Institution - 0050
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution - 0030
    • Guangzhou, Guangdong, China, 510655
      • Local Institution - 0029
• Germany
  • Kiel, Germany, 24105
    • Local Institution - 0012
• Hungary
  • Budapest, Hungary, 1083
    • Local Institution - 0062
  • Budapest, Hungary, 1088
    • Local Institution - 0023
• Italy
  • Pavia, Italy, 27100
    • Fondazione Irccs - Policlinico San Matteo
  • Lombardia
    • Rozzano, Lombardia, Italy, 20089
      • Humanitas
• Japan
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8545
      • Local Institution - 0063
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Local Institution - 0047
  • Saga
    • Saga-shi, Saga, Japan, 8498501
      • Local Institution - 0027
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 1138519
      • Local Institution - 0026
    • Minato-ku, Tokyo, Japan, 105-8471
      • Local Institution - 0044
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Local Institution - 0060
• Poland
  • Bydgoszcz, Poland, 85-231
    • Local Institution - 0022
  • Bydgoszcz, Poland, 85-794
    • Local Institution - 0003
  • Krakow, Poland, 31-501
    • Local Institution - 0001
  • Sopot, Poland, 81-756
    • Local Institution - 0028
  • Szczecin, Poland, 71-434
    • Local Institution - 0025
  • Warsaw, Poland, 00-728
    • Local Institution - 0035
  • Warsaw, Poland, 02-798
    • Local Institution - 0048
  • Warszawa, Poland, 03-712
    • Local Institution - 0004
  • Wroclaw, Poland, 53-114
    • Local Institution - 0018
  • Małopolskie
    • Nowy Targ, Małopolskie, Poland, 34-400
      • Local Institution - 0046
  • Śląskie
    • Tychy, Śląskie, Poland, 43-100
      • Local Institution - 0061
• Portugal
  • Santa Maria da Feira, Portugal, 4520-211
    • Local Institution - 0054
• Romania
  • Bucharest, Romania, 020125
    • Local Institution
• Russian Federation
  • Irkutsk, Russian Federation, 664033
    • Local Institution
  • Saint-Petersburg, Russian Federation, 195257
    • Local Institution
• Spain
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Local Institution - 0045
• Taiwan
  • Taipei, Taiwan, 10002
    • Local Institution - 0064
• United Kingdom
  • Morriston, United Kingdom, SA6 6NL
    • Local Institution - 0034
• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Local Institution - 0036
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Local Institution - 0002
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Local Institution - 0037
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 0041
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Local Institution - 0038
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Local Institution - 0066
  • Texas
    • Garland, Texas, United States, 75044
      • Local Institution - 0053
    • San Antonio, Texas, United States, 78229
      • Local Institution - 0056
    • Tyler, Texas, United States, 75701
      • Local Institution - 0049
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Local Institution - 0055

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long-Term Extension Rollover Study: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events (AEs)	Up to Week 292
Number of serious adverse events (SAEs)	Up to Week 292
Number of AEs leading to study discontinuation	Up to Week 292
Number of clinically significant abnormalities in vital signs: Blood pressure	Up to Week 292
Number of clinically significant abnormalities in vital signs: Heart rate	Up to Week 292
Number of clinically significant abnormalities in vital signs: Temperature	Up to Week 292
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval	Up to Week 292
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval	Up to Week 292
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval	Up to Week 292
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval	Up to Week 292
Number of clinically significant abnormalities in clinical laboratory results: Hematology tests	Up to Week 292
Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test	Up to Week 292
Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests	Up to Week 292

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Deucravacitinib; BMS-986165; Crohn Disease; Crohn Colitis; Crohn Iliocolitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: IM011-077; 2020-004461-40 (EudraCT Number); U1111-1258-3838 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No