Taking people in ArgentinaPhase 3
Compares two psoriasis drugs, deucravacitinib and ustekinumab, for long-term safety
Tests deucravacitinib against ustekinumab over time in adults with plaque psoriasis.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Autonomous City of Buenos Aires, Buenos Aires, C.a.b.a., CABA, Ciudad Autonoma Buenos Aires, Ciudad Autónoma Buenos Aires, Córdoba, and Mendoza, ArgentinaSee the 13 sitesAlso in 24 other countries, 388 sites
- Trial code
- NCT07116967
- EU 2023-503766-24-00
- U1111-1291-5815
- Registry title
- Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 3,040 people, planned
- Started
- 22 Sept 2025
- Expected to end
- 16 Jan 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Deucravacitinib
- Ustekinumab
- Record updated
- 28 October 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Argentina
Also in 24 other countries, 388 sites
- Derma Internacional S.A.Autonomous City of Buenos Aires, ArgentinaContact: Maria Laura Galimberti, Site 0453Taking people
- Buenos Aires Skin S.ABuenos Aires, ArgentinaContact: Matias Turienzo, Site 0032Taking people
- CONEXA Investigacion Clinica S.A.Buenos Aires, ArgentinaContact: Pablo Javier Gonzalez, Site 0061Taking people
- Hospital de Clinicas Jose de San MartinBuenos Aires, ArgentinaContact: Graciela Manzur, Site 0474Taking people
- Instituto de Neumonologia y DermatologiaBuenos Aires, ArgentinaContact: Paula Carolina Luna, Site 0227Taking people
- Buenos Aires, Buenos Aires F.D.Hospital not named in the registryNo longer taking part
- Consultorios Reumatológicos PampaC.a.b.a., ArgentinaContact: Cristina Echeverria, Site 0201Taking people
- Hospital Italiano de Buenos AiresCABA, ArgentinaContact: Luis Daniel Mazzuoccolo, Site 0197Taking people
- PsoriahueCiudad Autonoma Buenos Aires, ArgentinaContact: Gabriel Magarinos, Site 0043Taking people
- STAT Research S.A.Ciudad Autonoma Buenos Aires, ArgentinaContact: Claudio Greco, Site 0034Taking people
- CEMEDIAB - Centro Medico DiabetologicoCiudad Autónoma Buenos Aires, ArgentinaContact: Debora Kaplan, Site 0040Taking people
- Instituto de Investigaciones Clinicas Cordoba S.A.Córdoba, ArgentinaContact: Leandro Perrotat, Site 0455Taking people
- Viviana Parra Instituto Parra DermatologíaMendoza, ArgentinaContact: Viviana Parra, Site 0280Taking people
About the trial
What the trial wants to find out
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
The 2 groups in the trial
- Arm ATreatment being tested
Treatment: Deucravacitinib
- Arm BExisting treatment, for comparison
Treatment: Ustekinumab
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- Compares two psoriasis drugs, deucravacitinib and ustekinumab, for long-term safetyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 October 2026