Tildrakizumab for Psoriasis

(MINIMA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Marcelo F Di Carli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Marcelo F. Di Carli, MD, FACC

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults aged 18-90 with moderate-to-severe psoriasis and at least one cardiovascular risk factor can join this trial. They must have a stable statin dose for 6 months if applicable, and meet specific criteria like certain blood test results or body measurements. Those who've tried other psoriasis treatments need a wash-out period before starting.

Inclusion Criteria

I have stopped my previous skin treatments as required.

I have a heart risk factor like high cholesterol, diabetes, or a family history of heart disease.

I have metabolic syndrome with at least three of the specified conditions.

Exclusion Criteria

I am not on chronic oral prednisone >10mg/day, methotrexate, or other immunosuppressants.

I have not had serious infections or other cancers besides non-melanoma skin cancer in the last 5 years.

I have severe heart failure.

Treatment Details

Interventions

• Tildrakizumab (Monoclonal Antibodies)

Trial Overview The study is testing Tildrakizumab, an FDA-approved psoriasis drug that targets inflammation pathways, to see if it improves heart vessel function in people with psoriasis using advanced imaging techniques. The goal is to understand how reducing skin inflammation might lower the risk of heart problems.

Participant Groups

Group I: Subjects treated with Tildrakizumab Experimental Treatment 1 Intervention

Informed consent will be obtained from study participants willing to participate in MiNIMA. Study participants will then undergo the baseline rest/stress cardiac PET scan along with echocardiography. The final PET scan and echocardiogram will occur at 6 months after the intervention.

Tildrakizumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Ilumya for:

• Moderate to severe plaque psoriasis

🇺🇸 Approved in United States as Ilumya for:

• Moderate to severe plaque psoriasis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

Who Is Running the Clinical Trial?

Marcelo F. Di Carli, MD, FACC Lead Sponsor

References