Compares two psoriasis drugs, deucravacitinib and ustekinumab, for long-term safety
Tests deucravacitinib against ustekinumab over time in adults with plaque psoriasis.
Plain-language title generated from the registry record
Registry title: Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Key facts
- Where
- Bristol, High Wycombe, Kirkcaldy, London, Salford, and Southampton, United KingdomSee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with moderate-to-severe plaque psoriasis who have at least one heart-related risk factor.
- Age
- 40 years or older
- Sex
- All sexes can join.
- Disease stage
- Moderate-to-severe plaque psoriasis, where the investigator considers phototherapy or systemic treatment (including ustekinumab) an option.
Main reasons for not taking part
- Heart attack, stroke, coronary revascularization or blood clot in a vein (VTE) within 90 days before Day 1
- Unstable heart disease or a cardiac hospitalization within 90 days before Day 1
- Active cancer, or cancer within the previous 5 years (some treated skin and cervical cancers excepted)
- Other exclusion criteria set by the protocol
Read by machine on 9 November 2026.
Where in United Kingdom
- BristolBristol, United KingdomNot yet recruiting
- Velocity Clinical Research, High WycombeHigh Wycombe, United KingdomTaking people
- NHS Fife - Victoria HospitalKirkcaldy, United KingdomTaking people
- Barts Health NHS TrustLondon, United KingdomTaking people
- Guy's and St Thomas' NHS Foundation Trust - Guy's HospitalLondon, United KingdomTaking people
- Velocity Clinical Research - North LondonLondon, United KingdomTaking people
- Salford Care OrganisationSalford, United KingdomTaking people
- University Hospital Southampton NHS Foundation Trust - Southampton General HospitalSouthampton, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07116967EU 2023-503766-24-00
- Record updated
- 28 October 2026
- Original description
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasisRead full original descriptionShow less
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
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Inclusion: Participants with moderate-to-severe plaque psoriasis:; Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab; Have at least 1 of the following cardiovascular risk factors:; Current cigarette smoker; Diagnosis of hypertension; Diagnosis of hyperlipidemia; Diabetes mellitus type 1 or 2; History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack; Obesity; Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.
Exclusion: Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1; Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1; Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence); Other protocol define inclusion/exclusion criteria apply.