Inclusion Criteria:

• Male or female 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 ≤ 2 on the 11-point Numerical Rating Scale (NRS) for the 7 days prior to Day 1.
• C-Reactive Protein (CRP**) < 1.0 mg/dL within the 7 days of screening prior to Day 1 (Visit 1)
• 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.
• Women 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, 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.

Exclusion Criteria:

• 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; postthoracic 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 at baseline.
• 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.
• Sepsis, defined as documented bacteremia at baseline or other untreated or uncontrolled bacterial infection*
• Prior history of sustained ventricular arrhythmia(s)
• History of diagnosed long QT syndrome.
• QTc interval > 500 msec at baseline (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction)
• 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.
• Currently participating in any research trial involving investigational drugs or devices.
• 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 and unwilling to stay abstinent from all cannabis products for the duration of the trial.
• Pregnant or breastfeeding.
• Current diagnosis of 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 prior to randomization:
  • Methotrexate (within 2 weeks)
  • Azathioprine (within 24 weeks)
  • Cyclosporine (within 24 weeks)
  • Intravenous immune globulin (IVIG) (within 8 weeks)
  • Corticosteroids (within 4 weeks)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/25/2024. Questions regarding updates should be directed to the study team contact.