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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Deucravacitinib
DrugSpecified dose on specified days
Ustekinumab
DrugSpecified dose on specified days
Treatment groups
3,040 Participants
are divided into 2 treatment groupsGroup A: Arm AExperimental treatment 1 intervention
Group B: Arm BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
Time frame
Up to 5 yearsSecondary outcomes
1
Number of participants with non-fatal MI
Time frame
Up to 5 years2
Number of participants with non-fatal stroke
Time frame
Up to 5 years3
Death due to cardiovascular events
Time frame
Up to 5 years4
Number of participants with coronary revascularization
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov