CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled Trial

Exclusion criteria

• 1. Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker 2. 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) 3. Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted) 4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1) 5. 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). 6. Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection\* 7. Prior history of sustained ventricular arrhythmia(s) 8. History of diagnosed long QT syndrome 9. 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) 10. 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) 11. 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 12. Inability or unwillingness to give informed consent 13. Ongoing drug or alcohol abuse in the opinion of the investigator 14. On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial 15. Pregnant or breastfeeding 16. Current diagnosis of active cancer, with the exception of non-melanoma skin cancer 17. Any factor, which would make it unlikely that the patient can comply with the trial procedures 18. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment 19. Has received systemic immunomodulatory agents as below prior to randomization: 1. Methotrexate (within 2 weeks) 2. Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks) 3. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks) 4. Intravenous immune globulin (IVIG) (within 8 weeks) 5. Corticosteroids (within 4 weeks) 20. Known hypersensitivity to the active substance or any of the excipients of the trial