Testing CardiolRx against a placebo for recurrent pericarditis

Exclusion

• −Known hypersensitivity to the active substance or any of the excipients of the trial
• −Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
• −Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
• −Estimated glomerular filtration rate (eGFR) \< 30 mL/min during screeningScreeningThe checks done before joining, to see whether a study fits.Read more → within 7 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (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 trialInterventional studyA study where participants are given something to see what happens.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• −Ongoing drug or alcohol abuse in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
• −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)
• −Pregnant or breastfeeding
• −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)