Phase 4 Completed N=36 Treatment

MIcrovascular dysfuNction In Moderate-severe Psoriasis

Source: ClinicalTrials.gov NCT04271540 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcomePrimary: Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab — -0.03 CFR Ratio

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab	-0.03	—
SECONDARY Correlation Between Change in Global CFR and Psoriasis Skin Severity	0.18	0.35
SECONDARY Change in Peak-stress Global Myocardial Blood Flow	0.07	—
SECONDARY Change in Peak-stress Global Coronary Vascular Resistance	-1.1	—

Eligibility 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:

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 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.

Exclusion Criteria include the following:

Documented history of other systemic inflammatory diseases, including SLE and RA, which in the opinion of the investigator would be inappropriate for enrollment.
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
Renal insufficiency (CrCl 10mg/day, methotrexate, or other immunosuppressive agents.
Pregnancy and Breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04271540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.