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Tildrakizumab for Psoriasis (MINIMA Trial)
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.
MINIMA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMINIMA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MINIMA Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Subjects treated with Tildrakizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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