Now recruiting · Phase 3 · NCT06708299

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.

Find a research site → Read about the study

Why MAVERIC

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.

20+

research sites across the United States

Phase 3

randomized, double-blind, placebo-controlled

or older with recurrent pericarditis

Find a research site

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.

Recruiting

Not yet recruiting

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20+

research sites enrolling in 13 states across the US

or older with recurrent pericarditis

21 sites shown

Eligibility

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 Rating Scale (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 prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); systemic autoimmune disease (e.g., systemic lupus 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 skin cancer.

Additional criteria apply. Study site staff confirm full eligibility during screening.

About CardiolRx™

How does CardiolRx™ work?

Research suggests that the active pharmaceutical ingredient (API) in CardiolRx™ attenuates multiple inflammatory signaling pathways, including inhibiting activation of the NLRP3 inflammasome.

Pericardial insult or viral infection results in increased expression and activation of the NLRP3 inflammasome protein components which induce the release of pro-inflammatory cytokines (e.g., IL-1α, IL-1β, IL-6, & IL-18). This pro-inflammatory cytokine release perpetuates endothelial dysfunction, impairs vasodilation, and activates leukocytes, thereby leading to pericardial tissue damage, increased pericardial space and thickness, and a cyclic release of IL-1α.

This API has been shown to significantly decrease the pro-inflammatory cytokines IL-1β, IL-1α, and IL-6 and inhibit pro-IL-1β and NLRP3 mRNA expression in vitro, and significantly reduce pericardial effusion and thickness in a model of acute pericarditis.

NLRP3 = NACHT, leucine-rich repeat, and pyrin domain-containing protein 3

The investigational product

What it is

CardiolRx™ is a pharmaceutically manufactured oral solution. For additional information: cardiolrx.com

FDA status

CardiolRx™ is an investigational product not approved by the FDA. However, a similar product is FDA-approved and indicated for the treatment of seizures associated with certain epilepsy syndromes.

Taking part

What participation involves

Screening

To confirm eligibility study site staff review your medical history and perform screening assessments, including a C-Reactive Protein (CRP) test.

Randomized treatment

Because MAVERIC is randomized, double-blind and placebo-controlled, participants are assigned by chance to receive either CardiolRx™ oral solution or placebo.

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.

Questions & answers

Frequently asked questions

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.