Participants with recurrent pericarditis who do not have pericarditis secondary to prohibited conditions are eligible for the RHAPSODY Study. The study population includes both adult participants ≥18 years old and pediatric participants ≥12 and <18 years old with a history of at least 2 prior pericarditis episodes (including the first episode and 1 recurrence). Enrollment of pediatric participants will be limited to up to 20% of the study population.
To be eligible for the study, participants must present at screening with at least a third pericarditis episode, defined as at least 1 day with pericarditis pain measurement ≥4 on the 11-point Numerical Rating Scale (NRS) and C-reactive protein (CRP) value ≥1 mg/dL (either on the same day or separated by no more than 7 days) within 7 days prior to first study drug administration.
Participants included in the study may be receiving concomitant NSAIDs and/or colchicine and/or oral CS treatment in any combination, provided that the dosages of these medications have been stable (or not increased) for at least 3 days prior to first administration of study drug, and that changes in medications made within this time period (for instance, 1-time use of NSAIDs) are not anticipated by the investigator to significantly alter assessments of baseline disease activity.