MAVERIC-3
MAVERIC Phase 3 in Recurrent Pericarditis Currently Recruiting
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™ 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 below.
MAVERIC Sites Recruiting in the United States:
Locations
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Chadi Ayoub, MD
Email: ayoub.chadi@mayo.edu
United States, California
UCI Health Recruiting
Irvine, California, United States, 92697
Contact: Amin Sabet, MD
Email: sabeta1@hs.uci.edu
Altman Clinical and Translational Research Institute Not yet recruiting
La Jolla, California, United States, 92037
Contact: Ajit Raisinghani, MD
Email: araisinghani@health.ucsd.edu
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Paul Marano, MD
Email: Paul.Marano@cshs.org
Pacific Heart Institute at Cedars-Sinai Recruiting
Santa Monica, California, United States, 90404
Contact: Rigved Tadwalker, MD
Email: rtadwalkar@pacificheart.com
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Prajwal Reddy, MD
Email: reddy.prajwal@mayo.edu
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Mohammed Al-Kazaz, MD
Email: mohamed.alkazaz@nm.org
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Luigi Adamo, MD
Email: ladamo2@jhmi.edu
MedStar Health Institute Recruiting
Columbia, Maryland, United States, 21044
Contact: Syed Haider, MD
Email: Waqas.Haider@medstar.net
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jonathan Salik, MD
Email: jsalik@mgh.harvard.edu
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: David Lin, MD
Email: David.Lin@allina.com
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sushil A Luis, MD
Email: luis.s@mayo.edu
United States, New York
Columbia University – New York Presbyterian Recruiting
New York, New York, United States, 10032
Contact: Dor Lotan, MD
Email: dl3491@cumc.columbia.edu
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Michael Garshick, MD
Email: michael.garshick@nyulangone.org
Lenox Hill Hospital Recruiting
New York, New York, United States, 11030
Contact: Dennis Finkielstein, MD
Email: DFinkielstei@northwell.edu
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Saberio Lo Presti Vega, MD
Email: LOPRESS2@ccf.org
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Maan Malahfji, MD
Email: mmalahfji@houstonmethodist.org
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Libo Wang, MD
Email: Libo.Wang@utah.edu
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Tracy Hagerty, MD
Email: tracy.hagerty@uvmhealth.org
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Antonio Abbate, MD
Email: antonio.abbate@virginia.edu
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Contact: Georgia Thomas, MD
Email: georgia.thomas@vcuhealth.org
Cardiol Therapeutics Inc. Contacts
If you would like more information about the study, please contact:
Andrea B. Parker, PhD
+1 289 910 0862
Email: andrea.parker@cardiolrx.com
Heather Dalgleish, MSc
+1 289 910 0384
Email: heather.dalgleish@cardiolrx.com
What is the Investigational Product in MAVERIC Phase 3?
CardiolRx™ is a pharmaceutically manufactured solution. For more information: https://www.cardiolrx.com/pipeline/#section=cardiolrx.
Has CardiolRx™ been studied in other recurrent pericarditis clinical trials?
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.
Is CardiolRx™ approved by the United States FDA?
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.
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, 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
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.
