CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Recurrent Pericarditis

In brief

Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation. Double-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks. The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.

Key facts

Study ID

NCT06708299

Run by

Cardiol Therapeutics Inc.

People needed

110

Starts

2025-04-07

Expected to finish

2026-10-21

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older
• A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as:
• treatment with an IL-1 blocker 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 an IL-1 blocker; and
• treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.
• Pericarditis pain les or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least 7 days prior to randomization (Visit 1, Day 1)
• C-Reactive Protein (CRP) < 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
• Patients who have had a vasectomy or who are willing to use double barrier contraception methods with partners of childbearing potential during the conduct of the trial and for 2 months after the last dose of trial therapy.
• Patients of childbearing potential willing to use an acceptable method of contraception starting with trial therapy administration and for a minimum of 2 months after trial completion. Otherwise, these patients must be postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥ 40 mIU/mL [or ≥ 40 IU/L] if less than 2 years postmenopausal) or be surgically sterile.
• Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.

You may not qualify if…

• Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
• 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)
• Estimated glomerular filtration rate (eGFR) < 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
• Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST > 3x ULN plus bilirubin > 2x ULN during screening within 7 days prior to randomization (Visit 1, Day 1).
• Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection*
• Prior history of sustained ventricular arrhythmia(s)
• History of diagnosed long QT syndrome
• QTc interval > 480 msec (biologically female) or > 470 msec (biologically male) (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction) or second or third degree atrioventricular (AV) block in a patient without an implanted functioning pacemaker device during screening within 7 days prior to randomization (Visit 1, Day 1)
• Showing suicidal tendency during the last 12 months, as defined by answering "yes" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered during screening within 7 days prior to randomization (Visit 1, Day 1)
• 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
• Ongoing drug or alcohol abuse in the opinion of the investigator
• On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
• Pregnant or breastfeeding
• Current diagnosis of active cancer, with the exception of non-melanoma skin cancer
• Any factor, which would make it unlikely that the patient can comply with the trial procedures
• Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
• Has received systemic immunomodulatory agents as below prior to randomization:
• Methotrexate (within 2 weeks)
• Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)
• Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)
• Intravenous immune globulin (IVIG) (within 8 weeks)
• Corticosteroids (within 4 weeks)
• Known hypersensitivity to the active substance or any of the excipients of the trial

Where it is running

• Mayo Clionic Arizona — Phoenix, Arizona, United States (enrolling)
• UCI Health — Irvine, California, United States (enrolling)
• Altman Clinical and Translational Research Institute — La Jolla, California, United States (enrolling)
• University of Vermont — Burlington, Vermont, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• Jewish General Hospital — Montreal, Canada (enrolling)
• Hippokration General Hospital — Athens, Greece (enrolling)
• Pacific Heart Institute at Cedars-Sinai — Santa Monica, California, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• MedStar Health Institute — Columbia, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Columbia University - New York Presbyterian — New York, New York, United States (enrolling)
• Lenox Hill Hospital — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Houston Methodist Hospital — Houston, Texas, United States (enrolling)
• University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Padua — Padua, Italy
• University Hospital — Torino, Italy

Full record on ClinicalTrials.gov

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