A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,040
Specified dose on specified days
Specified dose on specified days
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
Time frame: Up to 5 years
Number of participants with non-fatal MI
Time frame: Up to 5 years
Number of participants with non-fatal stroke
Time frame: Up to 5 years
Death due to cardiovascular events
Time frame: Up to 5 years
Number of participants with coronary revascularization
Time frame: Up to 5 years
Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)
Time frame: Up to 5 years
Number of participants with pulmonary embolism (PE)
Time frame: Up to 5 years
Number of participants with deep vein thrombosis (DVT)
Time frame: Up to 5 years
Number of participants with composite venous thromboembolism (VTE)
PE, DVT and retinal vein occlusion
Time frame: Up to 5 years
Number of participants with arterial thromboembolic events (including retinal artery occlusion)
Time frame: Up to 5 years
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Local Institution - 0088
Birmingham, Alabama, United States
NOT_YET_RECRUITINGMedical Dermatology Specialists - Phoenix
Phoenix, Arizona, United States
RECRUITINGSaguaro Dermatology - Phoenix
Phoenix, Arizona, United States
RECRUITINGOmni Dermatology
Phoenix, Arizona, United States
RECRUITINGAlliance Dermatology
Phoenix, Arizona, United States
RECRUITINGLocal Institution - 0322
Scottsdale, Arizona, United States
WITHDRAWNLocal Institution - 0188
Scottsdale, Arizona, United States
WITHDRAWNScottsdale Clinical Trials
Scottsdale, Arizona, United States
RECRUITINGOmni Dermatology
Tempe, Arizona, United States
RECRUITINGClinical Trials Institute of Northwest Arkansas
Bentonville, Arkansas, United States
RECRUITING...and 398 more locations
Number of participants with heart failure (HF) requiring hospitalization or urgent visit
Time frame: Up to 5 years
Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC)
Time frame: Up to 5 years
Number of participants with NMSC
Time frame: Up to 5 years
Number of participants with opportunistic infections
Opportunistic infections include tuberculosis and complicated herpes zoster (eg, disseminated herpes zoster, affecting more than 2 dermatomes, ophthalmic or meningoencephalopathic involvement, and other atypical presentations)
Time frame: Up to 5 years
Number of participants with Serious AEs (SAEs)
Time frame: Up to 60 days after last dose
All-cause mortality
Time frame: Up to 60 days after last dose
AEs leading to permanent treatment discontinuation
Time frame: Up to 60 days after last dose
Change from baseline in liver function test
Time frame: Up to 60 days after last dose
Change from baseline in fasting lipid panel
Time frame: Up to 60 days after last dose