S. Allen Luis, M.B.B.S., Ph.D.

Closed for Enrollment

• An Open-Label Pilot Study of KPL-914 in Recurrent Pericarditis Jacksonville, Fla., Rochester, Minn.

  The study is comprised of 5 Parts:

  1. Part 1 enrolls symptomatic subjects with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein [CRP] > 1mg/dL).
  2. Part 2 enrolls symptomatic subjects with RIP with CRP ≤1 mg/dL which, in the opinion of the investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with
  3. pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab.
  4. Part 3 enrolls subjects with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis.
  5. Part 4 enrolls symptomatic subjects with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1mg/dL).
  6. Part 5 enrolls subjects with corticosteroid-dependent recurrent PPS not experiencing
• Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study Rochester, Minn.

  The purpose of this study is to evaluate the effect of treatment with CardiolRxTM on recurrent pericarditis.

• Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis (RHAPSODY) Rochester, Minn.

  The purpose of this study is to assess the effectiveness and safety of rilonacept treatment in subjects with recurrent pericarditis.

• RESONANCE–REgiStry Of the NAtural history of recurreNt periCarditis in pEdiatric and adult patients (RESONANCE) Rochester, Minn.

  The purpose of this study is to further the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.