CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation

Eligibility Criteria

• 1. Patients 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 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)
• 4. C-Reactive Protein (CRP) \< 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
• 5. 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.
• 6. 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.
• 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