BridgeMD
New treatment option for Recurrent Pericarditis
Official title CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
ClinicalTrials.gov ID: NCT06708299
What this study is testing
What is CardiolRx?
CardiolRx is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent pericarditis.
Also referred to as Pharmaceutically produced cannabidiol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.
You likely 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...
- 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...
- Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled...
See the full eligibility criteria
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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
- Current diagnosis of active 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 as below prior to randomization:
- Methotrexate (within 2 weeks)
- Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)
- Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)
- Intravenous immune globulin (IVIG) (within 8 weeks)
- Corticosteroids (within 4 weeks)
- Known hypersensitivity to the active substance or any of the excipients of the trial
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Columbia, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Burlington, Vermont, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
- Montreal, Canada
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Santa Monica, California, United States; Jacksonville, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.