CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3) (MAVERIC)

March 12, 2026 updated by: Cardiol Therapeutics Inc.

CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
  • Greece
      • Athens, Greece
        • Recruiting
        • Hippokration General Hospital
        • Contact:
  • Italy
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Irvine, California, United States, 92697
        • Not yet recruiting
        • UCI Health
        • Contact:
          • Amin Sabet, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Prajwal Reddy, MD
    • Illinois
      • Chicago, Illinois, United States, 60208
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Not yet recruiting
        • Johns Hopkins University
        • Contact:
          • Luigi Adamo, MD
      • Columbia, Maryland, United States, 21044
        • Not yet recruiting
        • MedStar Health Institute
        • Contact:
          • Syed Haider, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University - New York Presbyterian
        • Contact:
          • Dor Lotan, MD
      • New York, New York, United States, 11030
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • Dennis Finkielstein, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • Maan Malahfji, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • University of Utah Hospital
        • Contact:
          • Libo Wang, MD
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Charlottesville, Virginia, United States, 22903
      • Richmond, Virginia, United States, 23219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients 18 years of age or older

  2. 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.
  3. 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)
  4. C-Reactive Protein (CRP) < 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
  5. 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.
  6. 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:

  1. Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
  2. 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)
  3. Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
  4. Estimated glomerular filtration rate (eGFR) < 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
  5. 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).
  6. Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection*
  7. Prior history of sustained ventricular arrhythmia(s)
  8. History of diagnosed long QT syndrome
  9. 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)
  10. 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)
  11. 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
  12. Inability or unwillingness to give informed consent
  13. Ongoing drug or alcohol abuse in the opinion of the investigator
  14. On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
  15. Pregnant or breastfeeding
  16. Current diagnosis of active cancer, with the exception of non-melanoma skin cancer
  17. Any factor, which would make it unlikely that the patient can comply with the trial procedures
  18. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

  19. Has received systemic immunomodulatory agents as below prior to randomization:

    1. Methotrexate (within 2 weeks)
    2. Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)
    3. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)
    4. Intravenous immune globulin (IVIG) (within 8 weeks)
    5. Corticosteroids (within 4 weeks)
  20. Known hypersensitivity to the active substance or any of the excipients of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CardiolRx

  • Initial starting dose (Day 1, evening dose to Day 3, morning dose):

    5 mg/kg of body weight CardiolRx b.i.d.

  • Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d.

  • Day 10, evening dose to morning dose of the Week 24 Visit:

    10 mg/kg of body weight CardiolRx b.i.d.
Drug: CardiolRx
The intervention will be administered orally (via syringe) with food twice daily.
Other Names:
  • Pharmaceutically produced cannabidiol
Placebo Comparator: Placebo

  • Initial starting dose (Day 1, evening dose to Day 3, morning dose):

    5 mg/kg of body weight matching placebo b.i.d.

  • Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d.

  • Day 10, evening dose to morning dose of the Week 24 Visit:

    10 mg/kg of body weight matching placebo b.i.d.
Drug: CardiolRx
The intervention will be administered orally (via syringe) with food twice daily.
Other Names:
  • Pharmaceutically produced cannabidiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of pericarditis
Time Frame: 24 weeks
proportions of patients free from a new episode of recurrent pericarditis* from the timepoint of stopping the IL-1 blocker to Week 24
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of days with no or minimal pain
Time Frame: 24 weeks
the percentage of days with no or minimal pain as assessed by an NRS score ≤ 2 from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
restricted mean time to a new episode of pericarditis recurrence
Time Frame: week 24
the restricted mean time to a new episode of pericarditis recurrence from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)
week 24
the mean pain score
Time Frame: week 8, week 24
- the mean pain score using an 11-point NRS at Visit 6 (Week 8) and at Visit 9 (Week 24) (highest pain score recorded during the 7 days prior to Visit 6 and Visit 9)
week 8, week 24
the change in CRP
Time Frame: week 8, week 24
- the change in CRP from Visit 1 (Day 1) to Visit 6 (Week 8) and Visit 9 (Week 24)
week 8, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiol Therapeutics Inc.

Investigators

  • Principal Investigator: Paul Cremer, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

September 21, 2026

Study Completion (Estimated)

October 21, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiol 100-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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