Clinical Trials

Inclusion Criteria:

1. Male or female 18 years of age or older

2. Diagnosis of at least two episodes of recurrent pericarditis*,

3. At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS)
within prior 7 days

4. One of;

1. C-Reactive Protein** (CRP) level ≥1.0 mg/dL within prior 7 days OR

2. Evidence of pericardial inflammation assessed by delayed pericardial
hyperenhancement on cardiac magnetic resonance imaging (CMR)

5. Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine
and/or corticosteroids (in any combination) for treatment of pericarditis in stable
doses

6. Male patients with partners of childbearing potential who have had a vasectomy or are
willing to use double barrier contraception methods during the conduct of the study
and for 2 months after the last dose of study drug.

7. Women of childbearing potential willing to use an acceptable method of contraception
starting with study drug administration and for a minimum of 2 months after study
completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal
bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL
[or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.

- Diagnosis of pericarditis according to the 2015 European Society of Cardiology
(ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler
et al. 2015):

At least two of:

1. Pericarditic chest pain

2. Pericardial rub

3. New widespread ST-segment elevation or PR-segment depression according to
electrocardiogram (ECG) findings

4. Pericardial effusion (new or worsening)

- Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP

Exclusion Criteria:

1. 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); myocarditis

2. Estimated glomerular filtration rate (eGFR) <30 mL/min at screening

3. 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

4. Sepsis, defined as documented bacteremia at the time of screening or other documented
active infection

5. Prior history of sustained ventricular arrhythmia

6. History of QT interval prolongation

7. QTc interval > 500 msec

8. Current participation in any research study involving investigational drugs or device

9. Inability or unwillingness to give informed consent

10. Ongoing drug or alcohol abuse

11. On any cannabinoid during the past month

12. Women who are pregnant or breastfeeding

13. Current diagnosis of cancer, with the exception of non-melanoma skin cancer

14. Any factor, which would make it unlikely that the patient can comply with the study
procedures

15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS),
administered at screening

16. On digoxin and/or type 1 or 3 antiarrhythmics

17. On immunosuppressive therapy with any of the following:

1. Rilonacept

2. Anakinra

3. Canakinumab

4. Methotrexate

5. Azathioprine

6. Cyclosporine

7. Intravenous immune globulin (IVIG)

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

Eligibility last updated 3/28/23. Questions regarding updates should be directed to the study team contact.