Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorBristol-Myers Squibb
About this trial
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Eligibility criteria
Qualifiers
Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
Current cigarette smoker
Diagnosis of hypertension
Diagnosis of hyperlipidemia
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Deucravacitinib
- Ustekinumab
Treatment groups
3,040 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov