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Completed

NCT Number: NCT04877990

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

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0013, Ballarat, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Primary outcomes

  1. 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

  2. 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.

  3. Number of Participants With Electrocardiogram (ECG) Abnormalities

    Time frame: From first dose to 30 days post last dose (Up to 110 weeks)

  4. Number of Participants With Vital Signs Abnormalities

    Time frame: From first dose to 30 days post last dose (Up to 110 weeks)

  5. 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

  6. 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

  7. Change From Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline, Week 48, Week 96

    Changes from IM011077 study baseline in electrocardiogram (ECG) parameters

  8. 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

  9. Change From Baseline in Vital Signs Parameters

    Time frame: Baseline, Week 12, Week 108

    Changes from IM011077 study baseline in vital signs parameters

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 7, 2021
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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