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

August 28, 2024 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long-Term Extension Rollover Study: Deucravacitinib
Drug: Deucravacitinib
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: From first dose to 30 days post last dose (Up to 110 weeks)
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
Time Frame: From first dose to 30 days post last dose (Up to 110 weeks)
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
Time Frame: From first dose to 30 days post last dose (Up to 110 weeks)
From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Vital Signs Abnormalities
Time Frame: From first dose to 30 days post last dose (Up to 110 weeks)
From first dose to 30 days post last dose (Up to 110 weeks)
Change From Baseline in Laboratory Parameters
Time Frame: Baseline, Week 12, Week 108
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
Time Frame: Baseline, Week 48, Week 96
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
Time Frame: Baseline, Week 48, Week 96
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Baseline, Week 48, Week 96
Change From Baseline in Vital Signs Parameters - Heart Rate
Time Frame: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters - heart rate
Baseline, Week 12, Week 108
Change From Baseline in Vital Signs Parameters
Time Frame: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters
Baseline, Week 12, Week 108

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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