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 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	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment	From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Laboratory Abnormalities	Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.	From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Electrocardiogram (ECG) Abnormalities		From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Vital Signs Abnormalities		From first dose to 30 days post last dose (Up to 110 weeks)
Change From Baseline in Laboratory Parameters	Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function	Baseline, Week 12, Week 108
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate	Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate	Baseline, Week 48, Week 96
Change From Baseline in Electrocardiogram (ECG) Parameters	Changes from IM011077 study baseline in electrocardiogram (ECG) parameters	Baseline, Week 48, Week 96
Change From Baseline in Vital Signs Parameters - Heart Rate	Changes from IM011077 study baseline in vital signs parameters - heart rate	Baseline, Week 12, Week 108
Change From Baseline in Vital Signs Parameters	Changes from IM011077 study baseline in vital signs parameters	Baseline, Week 12, Week 108

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

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): September 24, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

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