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Monoclonal Antibodies
Tildrakizumab for Psoriasis (MINIMA Trial)
Phase 4
Recruiting
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
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.Check my eligibility
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.See study design
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 belowSelect...
I have stopped my previous skin treatments as required.
Select...
I have metabolic syndrome with at least three of the specified conditions.
Select...
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:Select...
I am not on chronic oral prednisone >10mg/day, methotrexate, or other immunosuppressants.
Select...
I have severe heart failure.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in global coronary flow reserve (CFR) after 6 months of therapy with Tildrakizumab
Secondary outcome measures
Change in LV peak global longitudinal strain and E'
Pulmonary Vascular Resistance
Change in peak-stress global myocardial blood flow
+2 moreTrial 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
~250
Find a Location
Who is running the clinical trial?
Marcelo F. Di Carli, MD, FACCLead Sponsor
3 Previous Clinical Trials
67 Total Patients Enrolled
Marcelo F Di Carli, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am not on chronic oral prednisone >10mg/day, methotrexate, or other immunosuppressants.I have moderate to severe psoriasis.I have not had serious infections or other cancers besides non-melanoma skin cancer in the last 5 years.I have severe heart failure.I have been on the same statin dose for at least 6 months.You are pregnant or breastfeeding.I am between 18 and 90 years old.My kidney function is low.I have a history of inflammatory diseases like lupus or rheumatoid arthritis.My skin condition affects more than 3% of my body or is moderately severe.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects treated with Tildrakizumab
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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