Kiniksa

100 Hayden Ave
Lexington, MA 02421

United States
781-431-9100
http://www.kiniksa.com

Booth: 2641

Profile

Kiniksa Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from devastating and debilitating diseases with significant unmet medical need. At Booth #2641, Kiniksa will be highlighting efforts related to recurrent pericarditis, a rare autoinflammatory condition with no FDA-approved therapies. Current treatments, utilizing nonspecific inhibitors of inflammation, can result in significant morbidity with chronic use. 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 alpha and IL-1 beta signaling. Kiniksa is evaluating the efficacy and safety of rilonacept in participants with recurrent pericarditis in a trial called RHAPSODY. RHAPSODY is now enrolling: Phase 3, double-blind, placebo-controlled, randomized withdrawal study with open-label extension (ClinicalTrials.gov Identifier: NCT03737110). Rilonacept in recurrent pericarditis is an investigational drug.

Videos

Products

The RHAPSODY Study

RHAPSODY is a Ph3, double-blind, placebo-controlled, randomized withdrawal study with open-label extension evaluating the efficacy and safety of rilonacept in recurrent pericarditis. Rilonacept in recurrent pericarditis is an investigational drug.... More Info Less Info

RHAPSODY is a Phase 3 clinical trial in recurrent pericarditis utilizing rilonacept (NCT03737110).

Study design for Rhapsody includes the following 5 periods: (1) Screening; (2) Single-blind run-in: participants receive a loading dose of rilonacept 320 mg injected SC followed by 160 mg SC weekly while background pericarditis medications are tapered and discontinued; (3) Double-blind, placebo-controlled 24-week randomized-withdrawal (RW): clinical responders to rilonacept are randomized 1:1 and receive 160 mg SC weekly rilonacept or placebo for at least 24 weeks; (4) Long-term extension treatment: after trial completion all subjects completing the RW period have the option to receive up to 24 weeks of open-label rilonacept 160 mg SC weekly; (5) Long-term extension follow-up: all subjects in the long-term extension period will be followed for 24 weeks for safety and pericarditis recurrences.

Rilonacept in recurrent pericarditis is an investigational drug.

Additional Info

ACC.19 Learning Pathways? (select one)

Interventional Cardiology