RECRUITING

CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation

Conditions

Recurrent Pericarditis IL-1 blocker-dependent recurrent pericarditis pharmaceutically cannabidial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.

Official Title

IMpAct of CardiolRxTM oVer 6 Months Following IL-1 Blocker Cessation in pERICarditis Patients - MAVERIC A Randomized, Double-blind, Placebo-controlled Trial

Quick Facts

Study Start:2025-04-07

Study Completion:2026-10-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06708299

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

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

Principal Investigator

Paul Cremer, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

UCI Health

Irvine, California, 92697

United States

Mayo Clinic

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

Collaborators and Investigators

Sponsor: Cardiol Therapeutics Inc.

Paul Cremer, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

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 Registration Dates

Study Start Date2025-04-07

Study Completion Date2026-10-21

Study Record Updates

Study Start Date2025-04-07

Study Completion Date2026-10-21

Terms related to this study

Keywords Provided by Researchers

IL-1 blocker-dependent recurrent pericarditis
pharmaceutically cannabidial

Additional Relevant MeSH Terms

Recurrent Pericarditis