CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation

Launched by CARDIOL THERAPEUTICS INC. · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called CardiolRx in patients with recurrent pericarditis, which is a condition where the lining around the heart becomes inflamed and can cause pain. Specifically, the trial is focusing on patients who have been treated with an IL-1 blocker for at least a year and are about to stop this treatment. The goal is to see if taking CardiolRx can help prevent the return of pericarditis symptoms after stopping the IL-1 blocker.

To be eligible for the trial, participants need to be at least 18 years old and have a history of recurrent pericarditis that has been stable for some time. This means they should have been free of symptoms for at least six months while on the IL-1 blocker. Participants can expect to receive either CardiolRx or a placebo (a pill with no active medication) for 24 weeks, starting about two weeks before their last dose of the IL-1 blocker. The study is not yet recruiting participants, so interested individuals will need to wait for it to start.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female 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 pain ≤ 2 on the 11-point Numerical Rating Scale (NRS) for at least the prior 7 days
• • 4. C-Reactive Protein (CRP\*\*) \< 1.0 mg/dL within the 7 days of screening prior to Day 1 (Visit 1)
• • 5. Male patients with partners of childbearing potential who have had a vasectomy or who are willing to use double barrier contraception methods during the conduct of the trial and for 2 months after the last dose of trial therapy
• • 6. Women of childbearing potential willing to use an acceptable method of contraception starting with trial drug administration and for a minimum of 2 months after trial completion. Otherwise, women 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.
• 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 at baseline
• • 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
• • 6. Sepsis, defined as documented bacteremia at baseline 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 \> 500 msec at baseline
• • 10. Showing suicidal tendency, as defined by answering "yes" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered at baseline
• • 11. Currently participating in any research trial involving investigational drugs or devices
• • 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 and unwilling to stay abstinent from all cannabis products for the duration of the trial
• • 15. Pregnant or breastfeeding
• • 16. Current diagnosis of 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 prior to randomization:
• • 1. Methotrexate (within 2 weeks)
• • 2. Azathioprine (within 24 weeks)
• • 3. Cyclosporine (within 24 weeks)
• • 4. Intravenous immune globulin (IVIG) (within 8 weeks)
• • 5. Corticosteroids (within 4 weeks).