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. It has five periods:
Assessment of disease characteristics, baseline therapy, and the pre-treatment workup (up to 4 weeks).
Blinded rilonacept is administered SC once weekly in all subjects while subjects are weaned from any standard of care therapies. Loading dose is 320 mg (or 4.4mg/kg for pediatric subjects) SC injection. (Duration of the run-in period undisclosed in order to maintain study subjects blinded to the start of the randomized-withdrawal period.)
Subjects who achieved Clinical Response during the run-in are randomized in a double-blind manner at a 1:1 ratio to either rilonacept SC injections once weekly (dose is 160 mg SC, or 2.2 mg/kg SC for pediatric subjects) or matching placebo SC injections. Patients will continue to receive rilonacept or placebo until either a pericarditis recurrence or the end of the RW period. (Duration is event driven: a prescribed number of pericarditis recurrences must have occurred, with a minimum of all subjects having received 24 weeks of treatment.)
All subjects completing the RW period will have an option to receive up to 24 weeks of open-label rilonacept 160 mg (or 2.2 mg/kg for pediatric subjects) SC injections once weekly. (24 weeks)
All subjects in the LTE-TP will be followed in the LTE-FUP for safety and potential pericarditis recurrences. (24 weeks)
Learn more at ClinicalTrials.gov Identifier: NCT03737110