Overall trial status: Ongoing, recruiting
Trial title: 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)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Romania:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Czechia:Ongoing, recruiting, France:Ongoing, recruiting, Hungary:Ongoing, recruiting, Italy:Ongoing, recruiting, Sweden:Authorised, recruitment pending, Poland:Authorised, recruitment pending, Denmark:Authorised, recruitment pending, Belgium:Authorised, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Secondary end point: 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
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 1289
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: USTEKINUMAB, USTEKINUMAB, deucravacitinib
Results posted: No
Overall decision date: 19/01/2026
Countries decision date: ES: 26/01/2026, PL: 26/01/2026, DE: 20/01/2026, RO: 26/01/2026, DK: 02/02/2026, BE: 02/02/2026, FR: 02/02/2026, IT: 02/02/2026, CZ: 16/02/2026, BG: 22/01/2026, SE: 02/02/2026, HU: 23/01/2026
Last updated date: 20/04/2026
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