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Monoclonal Antibodies

Tildrakizumab for Psoriasis (MINIMA Trial)

Phase 4

Waitlist Available

Led By Marcelo F Di Carli, MD

Research Sponsored by Marcelo F. Di Carli, MD, FACC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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

Must not have

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

NYHA class IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will test whether the FDA approved drug Tildrakizumab, which blocks the Th17 pathway of inflammation, can improve coronary vascular function and coronary flow reserve in people with psoriasis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Tildrakizumab may cause side effects such as infections due to immune system suppression, allergic reactions, injection site reactions, and potentially others not listed here based on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stopped my previous skin treatments as required.

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

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I have moderate to severe psoriasis.

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I have been on the same statin dose for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have severe heart failure.

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My kidney function is low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in global coronary flow reserve (CFR) after 6 months of therapy with Tildrakizumab

Secondary study objectives

Change in LV peak global longitudinal strain and E'

Pulmonary Vascular Resistance

Change in peak-stress global myocardial blood flow

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects treated with TildrakizumabExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tildrakizumab

2020

Completed Phase 4

~600

0 / 7Eligibility criteria met