CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation
a study on Pericarditis Cannabidiol
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Irvine, California and other locations
- Dates
- study startedcompletion around
Description
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 - 14 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
Details
Double-blind, randomised, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients with IL-1 blocker-dependent recurrent pericarditis can discontinue IL-1 blocker therapy and remain free of recurrence while receiving CardiolRx.
After informed consent is obtained, patients will be screened for eligibility. Baseline assessments will be performed during screening within 7 days of Day 1 (Visit 1) and include the following: Physical examination, vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; hematology (CBC with differential) and blood chemistry (including complete metabolic panel: sodium, potassium, calcium, glucose, ALT/AST, bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), creatinine/eGFR), C-SSRS and a pregnancy test for women of childbearing potential.
Eligible patients will be randomized on Day 1 to either CardiolRx or matching placebo. Double-blind trial therapy will be initiated in the evening of Day 1, 10 - 14 days 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.
Final efficacy assessments will take place 24 weeks after starting trial therapy and include a physical exam, vital signs, pain score NRS, a 12-lead ECG, as well as laboratory assessments (including a pregnancy test in women of childbearing potential) and a C-SSRS.
A safety follow-up visit will be scheduled 4 weeks after the last trial therapy administration.
Keywords
Recurrent Pericarditis, IL-1 blocker-dependent recurrent pericarditis, pharmaceutically cannabidial, Pericarditis, Recurrence, Cannabidiol, CardiolRx
Eligibility
You can join if…
Open to people ages 18 years and up
- Male or female 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 pain ≤ 2 on the 11-point Numerical Rating Scale (NRS) for at least the prior 7 days
- C-Reactive Protein (CRP**) < 1.0 mg/dL within the 7 days of screening prior to Day 1 (Visit 1)
- 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
- 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.
You CAN'T join 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 at baseline
- 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
- Sepsis, defined as documented bacteremia at baseline or other untreated or uncontrolled bacterial infection*
- Prior history of sustained ventricular arrhythmia(s)
- History of diagnosed long QT syndrome
- QTc interval > 500 msec at baseline
- 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
- Currently participating in any research trial involving investigational drugs or devices
- 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 and unwilling to stay abstinent from all cannabis products for the duration of the trial
- Pregnant or breastfeeding
- Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- Any factor, which would make it unlikely that the patient can comply with the trial procedures
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Has received systemic immunomodulatory agents prior to randomization:
- Methotrexate (within 2 weeks)
- Azathioprine (within 24 weeks)
- Cyclosporine (within 24 weeks)
- Intravenous immune globulin (IVIG) (within 8 weeks)
- Corticosteroids (within 4 weeks).
Locations
- UCI Health
not yet accepting patients
Irvine California 92697 United States - University of Utah Hospital
not yet accepting patients
Salt Lake City Utah 84112 United States - Mayo Clinic
accepting new patients
Rochester Minnesota 55905 United States - Northwestern University
accepting new patients
Chicago Illinois 60208 United States
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- Cardiol Therapeutics Inc.
- ID
- NCT06708299
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 110 study participants
- Last Updated