CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
Start Date
4/7/2025
Completion Date
10/21/2026
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.
Detailed 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 randomization at Visit 1 (Day 1). All other screening assessments will be performed at any time within 7 days prior to randomization at Visit 1 (Day 1) and include the following: Physical examination, vital signs, 12-lead ECG; C-SSRS and blood draws for local laboratory assessments (see Section 17.2). Eligible patients will be randomized at Visit 1 (Day 1) to either CardiolRx or matching placebo in a 1:1 ratio. Double-blind trial therapy will be initiated in the evening of Day 1, 10 - 16 days (no additional time window is allowed) prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks. Vital signs, ECG recording and blood draws for local and central laboratory analyses will be carried out at selected visits. Concomitant medications and (S)AEs will be recorded at all visits. Final efficacy assessments will take place at Visit 9, 24 weeks after randomization and start of trial therapy and include a physical exam, vital signs, pain score NRS collection, a 12-lead ECG, a C-SSRS, as well as blood draws for local and central laboratory assessments. A virtual safety follow-up visit (Visit 10) will be scheduled 4 weeks after the last trial therapy administration.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CardiolRx
Conditions
Locations
Mayo Clionic Arizona
Phoenix, Arizona 85054
United States
UCI Health
Irvine, California 92697
United States
Altman Clinical and Translational Research Institute
La Jolla, California 92037
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Pacific Heart Institute at Cedars-Sinai
Santa Monica, California 90404
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Northwestern University
Chicago, Illinois 60208
United States
Johns Hopkins University
Baltimore, Maryland 21205
United States
MedStar Health Institute
Columbia, Maryland 21044
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
NYU Langone Health
New York, New York 10016
United States
Columbia University - New York Presbyterian
New York, New York 10032
United States
Lenox Hill Hospital
New York, New York 11030
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
University of Utah Hospital
Salt Lake City, Utah 84112
United States
University of Vermont
Burlington, Vermont 05401
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Virginia Commonwealth University
Richmond, Virginia 23219
United States
Jewish General Hospital
Montreal,
Canada
Hippokration General Hospital
Athens,
Greece
Fatebenefratelli Hospital Milano
Milan,
Italy
University of Padua
Padua,
Italy
University Hospital
Torino,
Italy
University Hospital Udine
Udine,
Italy