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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Specified dose on specified days
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
Time frame: 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.
Time frame: 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)
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
Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Time frame: Baseline, Week 12, Week 108
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
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Local Institution - 0036
Shreveport, Louisiana, United States
Local Institution - 0002
Wyoming, Michigan, United States
Local Institution - 0037
Jackson, Mississippi, United States
Local Institution - 0041
Cleveland, Ohio, United States
Local Institution - 0038
Pittsburgh, Pennsylvania, United States
Local Institution - 0066
Charleston, South Carolina, United States
Local Institution - 0053
Garland, Texas, United States
Local Institution - 0056
San Antonio, Texas, United States
Local Institution - 0049
Tyler, Texas, United States
Local Institution - 0055
Richmond, Virginia, United States
...and 33 more locations
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Time frame: Baseline, Week 48, Week 96
Change From Baseline in Electrocardiogram (ECG) Parameters
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Time frame: 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
Time frame: Baseline, Week 12, Week 108
Change From Baseline in Vital Signs Parameters
Changes from IM011077 study baseline in vital signs parameters
Time frame: Baseline, Week 12, Week 108