MIcrovascular dysfuNction In Moderate-severe Psoriasis

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcelo F. Di Carli, MD, FACC
• Treatments: Antibodies, Monoclonal

Criteria

In order for an individual to participate, they must meet all of the inclusion and exclusion criteria as outlined below.

Inclusion Criteria include the following:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Moderate-to-severe psoriasis

4. Ages 40-80

5. Body surface area (BSA) involvement >5% and 5-point Physician Global Assessment (PGA) Score > 3 or Psoriasis Area and Severity Index (PASI) Score >12

6. 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.

7. Documented history of at least one of the following:

1. Hs-CRP >2 mg/L

2. Diabetes Mellitus

3. 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.

Exclusion Criteria include the following:

1. Documented history of other systemic inflammatory diseases, including SLE and RA, which in the opinion of the investigator would be inappropriate for enrollment.

2. Prior history of untreated chronic infection (tuberculosis), severe fungal infection, or known HIV positive, chronic hepatitis B or C infection), prior history of solid malignancy, myeloproliferative or lymphoproliferative disease within 5 years, excluding treated non-melanoma skin cancer

3. Renal insufficiency (CrCl <40 ml/min)

4. NYHA class IV heart failure

5. Patient on statin therapy prior to study enrollment

6. Patients requiring chronic treatment with oral prednisone >10mg/day, methotrexate, or other immunosuppressive agents.

7. Pregnancy, lactating, or women who plan to be pregnant. Female of child-bearing potential must document appropriate birth control methods for the entire study period.

8. Active COVID-19 infection

9. History of COVID-19 infection complicated by cardiac injury as assessed by hs-TnT or imaging