CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled Trial
Cardiol Therapeutics Inc.
Summary
Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation. Double-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks. The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Description
Double-blind, randomized, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx. Before any trial-related procedure is performed, written informed consent will be obtained. After informed consent is obtained, patients will be screened for eligibility. The highest NRS pain score within the past 7 days is to be assessed prior to randomization at Visit 1 (Day 1). Baseline blood samples for central laboratory assessment of hs-CRP and pharmacokinetic assessments should also be collected prior to rando…