MIcrovascular dysfuNction In Moderate-severe Psoriasis
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.
Conditions:
🦠 Psoriasis
🗓️ Study Start (Actual) 4 April 2020
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 35
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

  • 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. Moderate-to-severe psoriasis
  • 2. Ages 18-90
  • 3. Body surface area (BSA) involvement ≥ 3% OR 5-point Physician Global Assessment (PGA) Score ≥ 3 OR Psoriasis Area and Severity Index (PASI) score ≥ 12
  • 4. 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)
  • 5. 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.
  • 6. If the patient is on a statin therapy, they must be on a stable dose for at least 6 months prior to enrollment.
  • 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 active 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. Patients requiring chronic treatment with oral prednisone \>10mg/day, methotrexate, or other immunosuppressive agents.
  • 6. Pregnancy and Breastfeeding
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 February 2020
  • First Submitted that Met QC Criteria 13 February 2020
  • First Posted 17 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 February 2024
  • Last Update Posted 9 February 2024
  • Last Verified February 2024