CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)

Inclusion Criteria:

1. Patients 18 years of age or older

2. A history of recurrent pericarditis with stable disease and currently being treatedwith 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, ifpresent, must have occurred in the setting of an interruption or tapering of anIL-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 torandomization (Visit 1, Day 1).

5. Patients who have had a vasectomy or who are willing to use double barriercontraception methods with partners of childbearing potential during the conduct ofthe trial and for 2 months after the last dose of trial therapy.

6. Patients of childbearing potential willing to use an acceptable method ofcontraception starting with trial therapy administration and for a minimum of 2months after trial completion. Otherwise, these patients must be postmenopausal (atleast 1 year absence of vaginal bleeding or spotting and confirmed by folliclestimulating hormone [FSH] ≥ 40 mIU/mL [or ≥ 40 IU/L] if less than 2 yearspostmenopausal) or be surgically sterile.

Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.

Exclusion Criteria:

1. Pericarditis recurrence(s) during IL-1 blocker treatment without interruption ortapering 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 autoimmunedisease (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 7days prior to randomization (Visit 1, Day 1)

5. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5times the upper limit of normal (ULN) or ALT or AST > 3x ULN plus bilirubin > 2x ULNduring screening within 7 days prior to randomization (Visit 1, Day 1).

6. Sepsis, defined as documented bacteremia during screening within 7 days prior torandomization (Visit 1, Day 1) or other untreated or uncontrolled bacterialinfection*

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 pacedrhythm correction) or second or third degree atrioventricular (AV) block in apatient without an implanted functioning pacemaker device during screening within 7days 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 wasadministered within 30 days of screening or within 5 half-lives of the previousstudy 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 allcannabis 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 trialprocedures

18. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

19. Has received systemic immunomodulatory agents as below prior to randomization:

20. Methotrexate (within 2 weeks)

21. Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, ormercaptopurine (within 24 weeks)

22. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinaseinhibitors (within 12 weeks)

23. Intravenous immune globulin (IVIG) (within 8 weeks)

24. Corticosteroids (within 4 weeks)

25. Known hypersensitivity to the active substance or any of the excipients of the trial