Tildrakizumab for Psoriasis
(MINIMA Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
If you have previously used biologic therapy, topical steroids, phototherapy, or other systemic therapies for psoriasis, you will need to stop taking them for a certain period before joining the trial. If you are on statin therapy, you must have been on a stable dose for at least 6 months before enrolling.
Is Tildrakizumab safe for humans?
What makes the drug Tildrakizumab unique for treating psoriasis?
What data supports the effectiveness of the drug Tildrakizumab for treating psoriasis?
Tildrakizumab has been shown to be effective in treating moderate-to-severe chronic plaque psoriasis, as demonstrated by positive results from phase III clinical trials (reSURFACE 1 and reSURFACE 2) where it was superior to placebo and etanercept. It targets a specific part of the immune system (interleukin-23 p19) to help reduce symptoms.12579
Who Is on the Research Team?
Marcelo F Di Carli, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline imaging tests conducted and study drug dispensed
Treatment
Participants receive Tildrakizumab and are monitored for adverse events and compliance
Final Assessment
Final imaging tests conducted to assess changes in coronary flow reserve and myocardial function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tildrakizumab
Tildrakizumab is already approved in European Union, United States for the following indications:
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marcelo F. Di Carli, MD, FACC
Lead Sponsor