A Phase 2 Posology Study with Long-Term Extension in Participants with Well‑Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies

Condition studied

Well-Controlled Recurrent Pericarditis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Primary Efficacy Endpoint – Posology Period: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence., Primary Efficacy Endpoint – LTE Period: Annualized rate of Pericarditis Recurrence through the end of the LTE Period. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE Period.