CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)

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.

Timeline

Start

2025-04-07

Primary completion

2026-09-21

Completion

2026-10-21

Publications

• Background Imazio M, Klein AL, Brucato A, Abbate A, Arad M, Cremer PC, Insalaco A, LeWinter MM, Lewis BS, Lin D, Luis SA, Nicholls SJ, Sutej P, Wasserstrum Y, Clair J, Agarwal I, Wang S, Paolini JF; RHAPSODY Investigators. Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept. J Am Heart Assoc. 2024 Mar 19;13(6):e032516. doi: 10.1161/JAHA.123.032516. Epub 2024 Mar 12.
• Background M Imazio, L Trotta, E Bizzi, M Pancrazi, S Wang, J Clair, A L Klein, E Tombetti, A Brucato, J F Paolini, RHAPSODY Investigators, Multi-year recurrent pericarditis disease duration in Italian patients: clinical outcomes after cessation of long-term IL-1 pathway inhibition provide insights for chronic management, European Heart Journal, Volume 45, Issue Supplement_1, October 2024, ehae666.2104, https://doi.org/10.1093/eurheartj/ehae666.2104

Drugs

Indications