CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)

NCT06708299 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Cardiol 100-006
• Study Type: interventional
• Target: 110
• Locations: 4 countries
• Sites: 26

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, 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

Recurrent Pericarditis

Keywords

IL-1 blocker-dependent recurrent pericarditis; pharmaceutically cannabidial

Outcome Measures

Primary Outcomes (1)

• Recurrence of pericarditis

  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 Outcomes (1)

• Percentage of days with no or minimal pain

  24 weeks

Other Outcomes (3)

• restricted mean time to a new episode of pericarditis recurrence

  week 24

• the mean pain score

  week 8, week 24

• the change in CRP

  week 8, week 24

Study Arms (2)

CardiolRx

ACTIVE COMPARATOR

* 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

Placebo

PLACEBO COMPARATOR

* 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

Interventions

CardiolRx DRUG

The intervention will be administered orally (via syringe) with food twice daily.

Also known as: Pharmaceutically produced cannabidiol

CardiolRx; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• 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)
• C-Reactive Protein (CRP) \< 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
• 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.
• 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.

You may not qualify if:

• Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
• 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)
• Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
• 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\*
• Prior history of sustained ventricular arrhythmia(s)
• History of diagnosed long QT syndrome
• 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)
• 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)
• 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
• Inability or unwillingness to give informed consent
• Ongoing drug or alcohol abuse in the opinion of the investigator
• On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
• Pregnant or breastfeeding

Sponsors & Collaborators

• Cardiol Therapeutics Inc.: lead

Study Sites (26)

Mayo Clionic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

UCI Health

Irvine, California, 92697, United States

NOT YET RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60208, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

MedStar Health Institute

Columbia, Maryland, 21044, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Columbia University - New York Presbyterian

New York, New York, 10032, United States

RECRUITING

Columbia University - New York Presbyterian

New York, New York, 10032, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 11030, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

University of Utah Hospital

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

University of Vermont

Burlington, Vermont, 05401, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

RECRUITING

Jewish General Hospital

Montreal, Canada

RECRUITING

Hippokration General Hospital

Athens, Greece

RECRUITING

Fatebenefratelli Hospital Milano

Milan, Italy

NOT YET RECRUITING

University of Padua

Padua, Italy

NOT YET RECRUITING

University Hospital

Torino, Italy

NOT YET RECRUITING

University Hospital Udine

Udine, Italy

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 38471825 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

  BACKGROUND

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul Cremer, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea B Parker, MSc., PhD

CONTACT

+1 289 910 0862; andrea.parker@cardiolrx.com

Heather Dalgleish, MSc.

CONTACT

+1 289 910 0384; heather.dalgleish@cardiolrx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, placebo-controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GR (1); US (20); IT (4)