CompletedPhase 4

MIcrovascular dysfuNction In Moderate-severe Psoriasis

United States36 participantsStarted 2020-04-04

Plain-language summary

Psoriasis, a common chronic inflammatory skin disease affecting approximately 2% of the population, is associated with increased cardiovascular (CV) risk. Despite the implication of inflammation in this excess risk, it remains unclear whether reducing inflammation reduces the risk of cardiac events. This study proposes to test whether Tildrakizumab, an FDA approved therapy for psoriasis that blocks IL-23 and the Th17 pathway of inflammation, improves coronary vascular function and coronary flow reserve, as measured by noninvasive imaging with cardiac positron emission tomography. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms and prognosis. This research may offer novel insights into the contributors of CV risk in psoriasis and provide data to support the development of strategies to prevent cardiovascular events in psoriatic disease.

Who can participate

Age range18 Years – 90 Years

SexALL

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Exclusion criteria

✕. Moderate-to-severe psoriasis
✕. Ages 18-90
✕. Body surface area (BSA) involvement ≥ 3% OR 5-point Physician Global Assessment (PGA) Score ≥ 3 OR Psoriasis Area and Severity Index (PASI) score ≥ 12
✕. Patients who have failed biologic therapy, topical steroids, phototherapy, or other systemic therapies will be required to have a wash-out period, which will be calculated accordingly to the specific drug (Appendix 1)
✕. Evidence of at least one cardiovascular risk factor which includes hsCRP ≥ 2 mg/L, DM, obesity (BMI\>25), hyperlipidemia, hypertension, family history of early coronary artery disease, or evidence of metabolic syndrome
✕--Metabolic syndrome defined as at least three of the following: glucose\>100mg/dl or taking hypoglycemic agent, HDL\<40mg/dl (men) or 50 mg/dl (women), triglycerides ≥150mg/dl, waist circumference \>40 in mean or \>35 in women, or blood pressure ≥130/85 or taking anti-hypertensive.
✕. If the patient is on a statin therapy, they must be on a stable dose for at least 6 months prior to enrollment.
✕. Documented history of other systemic inflammatory diseases, including SLE and RA, which in the opinion of the investigator would be inappropriate for enrollment.

What they're measuring

Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab

Timeframe: 24 weeks

Trial details

NCT IDNCT04271540

SponsorMarcelo F. Di Carli, MD, FACC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-03

Results submitted2025-10-27

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