CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation

Eligibility Criteria

• 1. Male or female 18 years of age or older
• 2. 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.
• 3. Pericarditis pain more or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least the prior 7 days
• 4. C-Reactive Protein (CRP\*\*) \< 1.0 mg/dL within the 7 days of screening prior to Day 1 (Visit 1)
• 5. Male patients with partners of childbearing potential who have had a vasectomy or who are willing to use double barrier contraception methods during the conduct of the trial and for 2 months after the last dose of trial therapy
• 6. Women of childbearing potential willing to use an acceptable method of contraception starting with trial drug administration and for a minimum of 2 months after trial completion. Otherwise, women 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.
• 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 at baseline
• 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
• 6. Sepsis, defined as documented bacteremia at baseline 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 \> 500 msec at baseline
• 10. Showing suicidal tendency, as defined by answering "yes" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered at baseline
• 11. Currently participating in any research trial involving investigational drugs or devices
• 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 and unwilling to stay abstinent from all cannabis products for the duration of the trial
• 15. Pregnant or breastfeeding
• 16. Current diagnosis of 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 prior to randomization:
• 1. Methotrexate (within 2 weeks)
• 2. Azathioprine (within 24 weeks)
• 3. Cyclosporine (within 24 weeks)
• 4. Intravenous immune globulin (IVIG) (within 8 weeks)
• 5. Corticosteroids (within 4 weeks).