Impact of CardiolRxTM on Recurrent Pericarditis

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM (a pure cannabidiol [CBD] solution) is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiol Therapeutics Inc.

Criteria

Inclusion Criteria:

1. Male or female 18 years of age or older

2. Diagnosis of at least two episodes of recurrent pericarditis*,

3. At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days

4. One of;

1. C-Reactive Protein** (CRP) level ≥1.0 mg/dL within prior 7 days OR

2. Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR)

5. Has received non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) in stable doses for at least 3 days prior to enrolment

6. Male patients with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug.

7. Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.

• Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015):

At least two of:

1. Pericarditic chest pain

2. Pericardial rub

3. New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings

4. Pericardial effusion (new or worsening)

• Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP

Exclusion Criteria:

1. 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); myocarditis

2. Estimated glomerular filtration rate (eGFR) <30 mL/min

3. 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

4. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection

5. History of QT interval prolongation

6. QTc interval > 500 msec (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction)

7. Current participation in any research study involving investigational drugs or device

8. Inability or unwillingness to give informed consent

9. Ongoing drug or alcohol abuse

10. On any cannabinoid during the past month

11. Women who are pregnant or breastfeeding

12. Current diagnosis of cancer, with the exception of non-melanoma skin cancer

13. Any factor, which would make it unlikely that the patient can comply with the study procedures

14. Body weight > 170 kg

15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening

16. On immunosuppressive therapy with any of the following:

1. Rilonacept

2. Anakinra

3. Canakinumab

4. Methotrexate

5. Azathioprine

6. Cyclosporine

7. Intravenous immune globulin (IVIG)