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
- Asahikawa-shi, Chūōku, Fukuoka, Gifu, Kanazawa, Kurume, Fukuoka, Nagoya-sh, Okayama, Ōtsu, Sakaishi, Suita, Suita-shi, tabashi City, and Toyoake Shi, JapanSee the 15 sites
- Phase
- Phase 3
Where in Japan
- Asahikawa-shiAsahikawa-shi, JapanNo longer taking part
- St. Luke's International HospitalChūōku, JapanTaking people
- Fukuoka University HospitalFukuoka, JapanTaking people
- GifuGifu, JapanNo longer taking part
- KanazawaKanazawa, JapanNo longer taking part
- Kurume, FukuokaKurume, Fukuoka, JapanNo longer taking part
- Nagoya City University HospitalNagoya-sh, JapanTaking people
- OkayamaOkayama, JapanNot yet recruiting
- ŌtsuŌtsu, JapanNo longer taking part
- SakaishiSakaishi, JapanNo longer taking part
- SakaishiSakaishi, JapanNo longer taking part
- SuitaSuita, JapanNo longer taking part
- Suita-shiSuita-shi, JapanNo longer taking part
- Teikyo University Hospitaltabashi City, JapanTaking people
- Toyoake ShiToyoake Shi, JapanNo longer taking part
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.