CardiolRx in Recurrent Pericarditis A Randomized, Double-blind, Placebo-controlled Phase 3 Trial

What this Trial Is About

Researchers are evaluating CardiolRx in adults with recurrent pericarditis who have been stable on an IL-1 blocker treatment for at least 12 months and are planning to stop that treatment. This randomized, double-blind, placebo-controlled phase 3 trial aims to see if participants remain free from pericarditis recurrence while taking CardiolRx. The study is sponsored by Cardiol Therapeutics Inc. and involves monitoring the recurrence of pericarditis over a 24-week period. Participants will be randomly assigned to receive either CardiolRx or a matching placebo. The treatment is given orally twice daily with food, starting at 5 mg/kg twice daily for the first two days, then increasing to 7.5 mg/kg twice daily until day 10, and finally 10 mg/kg twice daily through week 24. The trial treatment begins 10 to 16 days before the last scheduled IL-1 blocker dose and continues for 24 weeks under double-blind conditions. During the study, participants will undergo regular assessments including pain scoring, physical examinations, vital signs, ECGs, and blood tests for inflammatory markers and safety monitoring. These evaluations occur at baseline, throughout treatment, and at the final 24-week visit, followed by a virtual safety follow-up 4 weeks after treatment ends. The main outcome measured is whether pericarditis recurs during the 24 weeks of treatment.

CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)