Actively Recruiting
CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
Led by Cardiol Therapeutics Inc. · Updated on 2026-03-13
110
Participants Needed
26
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- History of recurrent pericarditis with stable disease currently treated with an IL-1 blocker scheduled to be discontinued
- Treated with an IL-1 blocker for at least 12 months
- Free of pericarditis recurrence for at least 6 months; any recurrence occurred only during IL-1 blocker interruption or tapering
- Stable dose and regimen of IL-1 blocker for at least 3 months prior to randomization
- Pericarditis pain score of 2 or less on the 11-point Numerical Rating Scale for at least 7 days prior to randomization
- C-Reactive Protein (CRP) less than 1.0 mg/dL during screening within 7 days prior to randomization
- Patients who have had a vasectomy or willing to use double barrier contraception methods during the trial and for 2 months after last dose
- Patients of childbearing potential willing to use acceptable contraception starting with trial therapy and for at least 2 months after trial completion, or postmenopausal (at least 1 year without vaginal bleeding and confirmed by FSH levels) or surgically sterile
- Acceptable birth control methods include hormonal contraception inhibiting ovulation, intrauterine devices, double-barrier methods, bilateral tubal occlusion, vasectomised partner, or sexual abstinence
You will not qualify if you...
- Pericarditis recurrence during IL-1 blocker treatment without interruption or tapering
- Pericarditis caused by tuberculosis, cancer, purulent infection, radiation, blunt chest trauma, or systemic autoimmune diseases like lupus
- Primary diagnosis of myocarditis (myopericarditis allowed)
- Estimated kidney function (eGFR) less than 30 mL/min during screening
- Elevated liver enzymes (ALT or AST) more than 5 times normal or ALT/AST more than 3 times normal plus bilirubin over 2 times normal during screening
- Sepsis or untreated/uncontrolled bacterial infection during screening
- History of sustained ventricular arrhythmias
- Diagnosed long QT syndrome
- QTc interval over 480 msec (females) or 470 msec (males), or advanced heart block without pacemaker during screening
- Suicidal tendencies in the last 12 months as indicated by C-SSRS
- Participation in another investigational drug or device trial within 30 days or 5 half-lives of prior study drug
- Inability or unwillingness to provide informed consent
- Ongoing drug or alcohol abuse
- Use of cannabinoids in the past month or unwillingness to abstain during the trial
- Pregnant or breastfeeding
- Current active cancer except non-melanoma skin cancer
- Any factor likely to prevent compliance with trial procedures
- Moderate or severe liver impairment (Child-Pugh B or C)
- Recent use of systemic immunomodulatory drugs as specified within defined time frames
- Known allergy to CardiolRx or any of its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Mayo Clionic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
UCI Health
Irvine, California, United States, 92697
Not Yet Recruiting
3
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60208
Actively Recruiting
6
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
7
MedStar Health Institute
Columbia, Maryland, United States, 21044
Not Yet Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Not Yet Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
12
Columbia University - New York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
13
Columbia University - New York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
14
Lenox Hill Hospital
New York, New York, United States, 11030
Actively Recruiting
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Utah Hospital
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
18
University of Vermont
Burlington, Vermont, United States, 05401
Actively Recruiting
19
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
20
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
21
Jewish General Hospital
Montreal, Canada
Actively Recruiting
22
Hippokration General Hospital
Athens, Greece
Actively Recruiting
23
Fatebenefratelli Hospital Milano
Milan, Italy
Not Yet Recruiting
24
University of Padua
Padua, Italy
Not Yet Recruiting
25
University Hospital
Torino, Italy
Not Yet Recruiting
26
University Hospital Udine
Udine, Italy
Not Yet Recruiting
Research Team
A
Andrea B Parker, MSc., PhD
CONTACT
H
Heather Dalgleish, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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