The RHAPSODY Study
The RHAPSODY Study is actively recruiting patients with recurrent pericarditis. The study will evaluate the efficacy and safety of rilonacept, an investigational medication that blocks IL-1 by acting as a soluble decoy receptor which binds IL-1α and IL-1β and prevents its interaction with cell surface receptors.
Primary Objective: To assess the efficacy of rilonacept in subjects with recurrent pericarditis.
Secondary Objective: To assess the safety of rilonacept in subjects with recurrent pericarditis.
The RHAPSODY Study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study with open-label extension to assess the efficacy and safety of rilonacept treatment in patients with recurrent pericarditis.
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-1α and IL-1β signaling. Kiniksa is evaluating the efficacy and safety of rilonacept in participants with recurrent pericarditis potentially to address the unmet need in the treatment of this disease.