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
Overview
- Phase
- Phase 2
- Intervention
- Deucravacitinib
- Conditions
- Crohn Disease
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 67
- Locations
- 41
- Primary Endpoint
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Long-Term Extension Rollover Study: Deucravacitinib
Intervention: Deucravacitinib
Outcomes
Primary Outcomes
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
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.
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time Frame: 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)
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
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
Change From Baseline in Electrocardiogram (ECG) Parameters
Time Frame: Baseline, Week 48, Week 96
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
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
Change From Baseline in Vital Signs Parameters
Time Frame: Baseline, Week 12, Week 108
Changes from IM011077 study baseline in vital signs parameters