Key Inclusion Criteria
Each subject must meet all of the following criteria to be enrolled in this study:
- Is male or female 12 years of age or older with body weight of at least 23.6 kg (52 Lbs).
- Has a diagnosis of recurrent pericarditis.
- At least 1 of the pericarditis episodes experienced prior to screening has met at least 2 of the following 4 criteria, in the opinion of the investigator and based on the documented available data, according to the 2015 ESC Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al 2015):
- Pericarditic chest pain
- Pericardial rub
- New widespread ST-segment elevation or PR-segment depression according to ECG findings
- Pericardial effusion (new or worsening)
- Presents with at least the third episode of pericarditis during screening (i.e., at least the second pericarditis recurrence following the first pericarditis episode), and within 7 days* prior to and including RI baseline (first administration of study drug) has:
- At least 1 day with pericarditis pain ≥4 on the 11-point NRS, AND
- CRP level ≥1.0 mg/dL (for details of CRP collection see Section 6.1.1)
*Pericarditis pain ≥4 and CRP ≥1 mg/dL are not required to be present on the same day.
- Has received NSAIDs and/or colchicine and/or CS (in any combination), if used, at stable dose levels (or at least not increased) for at least 3 days prior to and including RI baseline (first administration of study drug), and changes in medications made within this time period (e.g., 1-time use of NSAIDs) are not anticipated, in the opinion of the investigator, to significantly alter assessments of baseline disease activity.
- If using NSAIDs and/or colchicine and/or CS at the time of RI baseline (first administration of study drug), is willing and able, in the opinion of the investigator, to taper and discontinue those medications within the 9-week weaning time in the RI period of the study while continuing rilonacept treatment.
Key Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from the study:
- Has a 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; or systemic autoimmune diseases with exception of Still’s disease.
- Is currently receiving CS at a dose of >60 mg/day prednisone (or equivalent) for adult subjects, or >0.5 mg/kg/day (or >60 mg/day, whichever is lower) prednisone (or equivalent) in pediatric subjects (≥12 and <18 years old).
- Has ever received cytotoxic drugs, including cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents.
- Has ever received agents that deplete B or T cells (e.g., rituximab, alemtuzumab).
- Has received systemic immunomodulatory agents (with exception of CS) within the following time frames prior to RI baseline (first administration of study drug):
- Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine within 24 weeks.
- TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors within 12 weeks.
- Canakinumab within 12 weeks. Canakinumab could not have been discontinued due to safety unless it was discontinued due to local injection site reactions.
- Rilonacept within 6 weeks. Rilonacept could not have been discontinued due to lack of efficacy or due to safety.
- Methotrexate within 2 weeks.
- Anakinra within 5 days. Anakinra could not have been discontinued due to lack of efficacy or due to safety unless it was discontinued due to local injection site reactions.
Please see full protocol for additional inclusion and exclusion criteria.
Learn more at ClinicalTrials.gov Identifier: NCT03737110