NCT04271540CompletedPhase 4
MIcrovascular dysfuNction In Moderate-severe Psoriasis
Effects of Tildrakizumab on Coronary Microvascular Function in Moderate-Severe Psoriasis
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 13 Feb 2020
- Start date
- 4 Apr 2020
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Marcelo F. Di Carli, MD, FACC
- Diseases
- Psoriasis
- NCT number
- NCT04271540
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 36
- From 4 Apr 2020 to the primary completion date, 3 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients requiring chronic treatment with oral prednisone \>10mg/day, methotrexate, or other immunosuppressive agents.
Other illness
- Documented history of other systemic inflammatory diseases, including SLE and RA, which in the opinion of the investigator would be inappropriate for enrollment.
- Renal insufficiency (CrCl \<40 ml/min)
- NYHA class IV heart failure
Other
- Pregnancy and Breastfeeding
Who the study is looking for
- 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.
Criteria the registry did not label
- In order for an individual to participate, they must meet all of the inclusion and exclusion criteria as outlined below.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.