Study Objectives and Rationale

Recurrent pericarditis is a rare autoinflammatory condition with no approved therapies. Current treatments, utilizing nonspecific inhibitors of inflammation (nonsteroidal anti-inflammatory drugs [NSAIDs], colchicine, corticosteroids [CS]), result in significant morbidity with chronic use. Some patients develop CS dependency or require surgical pericardiectomy to treat the symptoms of their disease.

The interleukin-1 (IL-1) pathway plays a major role in the pathophysiology of recurrent pericarditis. Rilonacept (KPL-914) is a recombinant fusion protein that blocks IL-1 signaling. It is currently approved for treatment of another autoinflammatory condition, Cryopyrin-Associated Periodic Syndrome (CAPS). Based on its IL-1–antagonistic properties and pharmacokinetics (PK), which allow for once-weekly subcutaneous (SC) injections, it is reasonable to evaluate the efficacy and safety of rilonacept in subjects with recurrent pericarditis to address the unmet need in treatment of this disease.