Under construction – not a live service
Sign in
Taking people in BrazilPhase 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
Botucatu, Campinas, Curitiba, João Pessoa, Juiz de Fora, Porto Alegre, Ribeirão Preto, Salvador, Santo André, São José do Rio Preto, São Paulo, and Vila Clementino, BrazilSee the 15 sitesAlso in 24 other countries, 386 sites
Trial code
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 Brazil

Also in 24 other countries, 386 sites

  • Faculdade de Medicina da UNESP-Upeclin - Faculdade de Medicina de Botucatu - UNESPBotucatu, BrazilContact: Luciane Donida Bartoli Miot, Site 0399Taking people
  • Universidade Estadual de Campinas - Cidade Universitária Zeferino VazCampinas, BrazilContact: Renata Ferreira Magalhaes, Site 0383Taking people
  • Hospital Universitario Evangelico de CuritibaCuritiba, BrazilContact: Anber Tanaka, Site 0384Taking people
  • Pontifícia Universidade Católica do ParanáCuritiba, BrazilContact: Caio Cesar Silva De Castro, Site 0416Taking people
  • João Pessoa, ParaíbaHospital not named in the registryContact: Site 0385Not yet recruiting
  • Centro Mineiro de Pesquisa - CMiPJuiz de Fora, BrazilContact: Silviane Vassalo, Site 0037Taking people
  • Centro de Pesquisa Clínica da Associação Hospitalar Moinhos de VentoPorto Alegre, BrazilContact: Andre Vicente Esteves De Carvalho, Site 0036Taking people
  • Centro de Pesquisa Clínica do Hospital de Clínicas de Porto AlegrePorto Alegre, BrazilContact: Tania Cestari, Site 0390Taking people
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRPRibeirão Preto, BrazilContact: Cacilda da Silva Souza, Site 0193Taking people
  • Clinica IbisSalvador, BrazilContact: Gleison Vieira Duarte, Site 0027Taking people
  • Faculdade de Medicina do ABCSanto André, BrazilContact: Luiza Keiko Matsuka Oyafuso, Site 0450Taking people
  • Faculdade de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilContact: Joao Roberto Antonio, Site 0400Taking people
  • São PauloHospital not named in the registryContact: Site 0039Not yet recruiting
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de São PauloSão Paulo, BrazilContact: Ricardo Romiti, Site 0346Taking people
  • PSEG- Pesquisa ClínicaVila Clementino, BrazilContact: Maria Victoria Suarez Restrepo, Site 0490Taking 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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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