HEALTHCARE PROFESSIONALS

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.

Study Objectives

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.

Methodology

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.

Find a Study Location

The RHAPSODY Study will be conducted in the United States, Israel, Italy, and Australia.

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Study 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-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.