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Monoclonal Antibodies

Tildrakizumab for Psoriasis (MINIMA Trial)

Q: Who is eligible to join this research initiative?

<p>Aspiring participants should have <a href="https://www.withpower.com/clinical-trials/psoriasis">psoriasis</a>, be aged between 18 and 90 years old, and are limited to 35 spots in total.</p>

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

MINIMA Trial 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.

MINIMA Trial 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 a heart risk factor like high cholesterol, diabetes, or a family history of heart disease.

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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.

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I am between 18 and 90 years old.

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My skin condition affects more than 3% of my body or is moderately severe.

MINIMA Trial 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

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 more

MINIMA 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

2019

Completed Phase 4

~190

0 / 7Eligibility criteria met

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

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04271540 — Phase 4

Psoriasis Research Study Groups: Subjects treated with Tildrakizumab

Psoriasis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT04271540 — Phase 4

Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04271540 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have researchers observed any outcomes when treating individuals with Tildrakizumab?

"Currently, there are 10 ongoing research studies for participants treated with tildrakizumab, 2 of which are in Phase 3. Milwaukee, Wisconsin houses most of these trials but 106 other locales across the United States offer this medication as well."

Answered by AI

What is the aggregate enrolment of participants in this research?

"Affirmative. According to clinicaltrials.gov, the trial which was posted on April 4th 2020 is presently recruiting people for participation. 35 individuals are needed from 1 medical facility and the last update of this information occurred November 1st 2022."

Answered by AI

Has the FDA greenlit Tildrakizumab treatments?

"Our Power team rated the safety of those receiving tildrakizumab a 3 due to this being a Phase 4 trial, which is indicative that it has already been approved."

Answered by AI

Who is eligible to join this research initiative?

"Aspiring participants should have psoriasis, be aged between 18 and 90 years old, and are limited to 35 spots in total."

Answered by AI

Are participants aged 18 and above eligible for this research endeavor?

"This trial mandates that participants be aged 18-90, however there are 32 separate trials for minors and 151 studies targeting the elderly."

Answered by AI

Does this medical research still need participants to join?

"Per the information posted on clinicaltrials.gov, this experiment is actively recruiting participants. It was initially registered on April 4th 2020 and has been updated as of November 1st 2022."

Answered by AI

Does this research add to existing knowledge of the subject?

"Currently, there are 10 live studies on tildrakizumab across 9 countries and 52 cities. This investigational drug was first tested in a Phase 2 & 3 clinical trial sponsored by Sun Pharma Global FZE back in 2020 which included 120 participants. Since then, 7 more trials have been conducted to further explore the efficacy of this treatment modality."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MIcrovascular dysfuNction In Moderate-severe Psoriasis

Marcelo F. Di Carli, MD, FACC 2020. "MIcrovascular dysfuNction In Moderate-severe Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04271540.

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