Phase 3 Trial of CardiolRx to Prevent Recurrence of Recurrent Pericarditis in Adults

What this Trial Is About

This research investigates the prevention of recurrent pericarditis in patients who have a history of this condition and have been treated with an IL-1 blocker for at least 12 months. The study is a multi-center, randomized, double-blind, placebo-controlled Phase-3 trial aiming to evaluate whether patients remain free of pericarditis recurrence while receiving the study drug CardiolRx. Participants will be randomly assigned to receive either CardiolRx or a matching placebo. The treatment begins 10 to 16 days before the last scheduled dose of the IL-1 blocker and continues for 24 weeks. CardiolRx or placebo is administered orally twice daily with food, starting at 5 mgkg twice daily for the first few doses, increasing to 7.5 mgkg, and then to 10 mgkg twice daily through Week 24. Throughout the study, participants will undergo various assessments including physical exams, vital signs, ECGs, blood tests for inflammation markers, and pain evaluations using a numerical rating scale. Safety monitoring includes recording adverse events and concomitant medications at all visits. After 24 weeks of treatment, a final efficacy assessment occurs, followed by a virtual safety follow-up visit four weeks after the last dose. The primary outcome is the recurrence of pericarditis during the 24 weeks of treatment.

CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)