MAVERIC-3 New
MAVERIC
MAVERIC Phase 3 in Recurrent Pericarditis
Currently Recruiting
A multi-center, randomized, double-blind, placebo-controlled Phase 3 trial
evaluating CardiolRx™ oral solution in adults with recurrent pericarditis.
A Phase 3 study for people living with recurrent pericarditis
MAVERIC is evaluating CardiolRx™ oral solution and its impact on the risk of pericarditis recurrence. The study is enrolling adults across the United States who have a history of recurrent pericarditis and are currently being treated with rilonacept (Arcalyst®).
If you may be eligible, the most direct next step is to contact a research site near you.
MAVERIC Sites Recruiting in the United States:
If you are a patient interested in learning more about MAVERIC and determining if you are eligible to participate, or if you are a physician who is interested in referring a patient, please contact one of the MAVERIC clinical trial sites listed here.
Who is Eligible for the Study?
Key Inclusion Criteria:
- Patients 18 years of age or older.
- A history of recurrent pericarditis with stable disease and currently being treated with rilonacept (Arcalyst®), scheduled to be discontinued. Stable disease is defined as:
- Treatment with rilonacept for at least 12 months,
- Free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of rilonacept; and,
- Treatment with an unchanged dose and regimen of rilonacept for at least 3 months prior to randomization.
- Pericarditis pain less than or equal to 2 on the 11-point Numerical RatingScale (NRS) for at least 7 days prior to randomization.
- C-Reactive Protein (CRP) < 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
Key Exclusion Criteria:
- Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of rilonacept (Arcalyst®).
- Diagnosis of pericarditis that is secondary to specific prohibitedetiologies, including tuberculosis (TB); neoplastic, purulent, or radiationetiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); systemicautoimmune disease (e.g., systemiclupus erythematosus).
- Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted).
- Participation in a clinical trial in which an investigational drug or device was administered within 30 days of screening or within 5 half-lives of the previous study drug, whichever is longer.
- Inability or unwillingness to give informed consent.
- Pregnant or breastfeeding.
- Current diagnosis of active cancer, with the exception of non-melanoma skincancer.
About the Cardiol 100-006 Study (MAVERIC Phase 3)
MAVERIC is a multi-center, randomized, double-blind, placebo-controlled, Phase 3 trial assessing the impact of CardiolRx™ oral solution on the risk of pericarditis recurrence. (ClinicalTrials.gov Identifier: NCT06708299)
If you are a patient interested in learning more about MAVERIC and determining if you are eligible to participate, or if you are a physician who is interested in referring a patient, please contact one of the MAVERIC clinical trial sites listed above.
What participation involves
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Screening
To confirm eligibility study site staff review your medical history and perform screening assessments, including a C-Reactive Protein (CRP) test.
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Randomized treatment
Because MAVERIC is randomized, double-blind and placebo-controlled, participants are assigned by chance to receive either CardiolRx™ oral solution or placebo.
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Voluntary participation
Taking part is voluntary. Giving informed consent is required to participate in the study, and you can discuss any questions with the study site team.
Frequently Asked Questions
CardiolRx™ is a pharmaceutically manufactured oral solution.
Yes. A completed Phase 2 study (ClinicalTrials.gov Identifier: NCT05494788), which has led to advancing to the MAVERIC Phase 3 trial, showed that pericarditis patients treated with CardiolRx™ experienced marked, rapid and durable reductions in pericarditis pain and inflammation, and a substantial reduction in the number of pericarditis recurrences per year.
No. CardiolRx™ is an investigational product. However, a similar product is FDA-approved and indicated for the treatment of seizures associated with certain epilepsy syndromes.
MAVERIC is a randomized, double-blind, placebo-controlled trial, so participants are assigned by chance to receive either CardiolRx™ oral solution or placebo, and neither participants nor study staff know the assignment.
Cardiol Therapeutics Inc. Contacts
If you would like more information about the study please contact:
clinical.trials@cardiolrx.com
