Status:
RECRUITING
CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
Lead Sponsor:
Cardiol Therapeutics Inc.
Conditions:
Recurrent Pericarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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, schedule...
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-rela...
Eligibility Criteria
Inclusion Criteria:
-
Patients 18 years of age or older
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A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as:
- treatment with an IL-1 blocker for at least 12 months,
- free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of an IL-1 blocker; and
- treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.
-
Pericarditis pain les or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least 7 days prior to randomization (Visit 1, Day 1)
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C-Reactive Protein (CRP) < 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
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Patients who have had a vasectomy or who are willing to use double barrier contraception methods with partners of childbearing potential during the conduct of the trial and for 2 months after the last dose of trial therapy.
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Patients of childbearing potential willing to use an acceptable method of contraception starting with trial therapy administration and for a minimum of 2 months after trial completion. Otherwise, these patients must be postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥ 40 mIU/mL [or ≥ 40 IU/L] if less than 2 years postmenopausal) or be surgically sterile.
Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Exclusion Criteria:
-
Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
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Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); systemic autoimmune disease (e.g., systemic lupus erythematosus)
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Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
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Estimated glomerular filtration rate (eGFR) < 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
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Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST > 3x ULN plus bilirubin > 2x ULN during screening within 7 days prior to randomization (Visit 1, Day 1).
-
Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection*
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Prior history of sustained ventricular arrhythmia(s)
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History of diagnosed long QT syndrome
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QTc interval > 480 msec (biologically female) or > 470 msec (biologically male) (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction) or second or third degree atrioventricular (AV) block in a patient without an implanted functioning pacemaker device during screening within 7 days prior to randomization (Visit 1, Day 1)
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Showing suicidal tendency during the last 12 months, as defined by answering "yes" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered during screening within 7 days prior to randomization (Visit 1, Day 1)
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Participation in a clinical trial in which an investigational drug or device was administered within 30 days of screening or within 5 half-lives of the previous study drug, whichever is longer
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Inability or unwillingness to give informed consent
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Ongoing drug or alcohol abuse in the opinion of the investigator
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On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
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Pregnant or breastfeeding
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Current diagnosis of active cancer, with the exception of non-melanoma skin cancer
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Any factor, which would make it unlikely that the patient can comply with the trial procedures
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Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
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Has received systemic immunomodulatory agents as below prior to randomization:
- Methotrexate (within 2 weeks)
- Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)
- Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)
- Intravenous immune globulin (IVIG) (within 8 weeks)
- Corticosteroids (within 4 weeks)
-
Known hypersensitivity to the active substance or any of the excipients of the trial
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 21 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06708299
Start Date
April 7 2025
End Date
October 21 2026
Last Update
March 13 2026
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clionic Arizona
Phoenix, Arizona, United States, 85054
2
UCI Health
Irvine, California, United States, 92697
3
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
4
Mayo Clinic
Jacksonville, Florida, United States, 32224