A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

Condition studied

Moderate to Severe Plaque Psoriasis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization

Endpoint detail

Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster, SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation, Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter