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IMpAct of CardiolRxTM oVer 6 months following IL-1 Blocker cessation in pERICarditis patients – MAVERIC: A randomized, double-blind, placebo-controlled trial
EU CTIS ID: 2024-517688-21-00
What this study is testing
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. The primary safety objective is to demonstrate that administration of CardiolRx in the proposed doses in this patient population is safe and well tolerated.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. *Documented history of recurrent pericarditis is defined as a prior recurrent pericarditis episode with pericarditic chest pain AND elevated CRP ≥ 1.0 mg/dL.
- Pericarditis pain ≤ 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). **The term “CRP” will be used in this protocol for CRP and high-sensitivity CRP (hs-CRP) analyses performed at local laboratories for the evaluation of eligibility and suspected pericarditis recurrences. If available, hs-CRP is the preferred analysis method to be used.
- Male 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.
- WOCBP*** willing to use an acceptable method of contraception starting with trial therapy 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. Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.
You likely can't join if
- Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Has received systemic immunomodulatory agents as below prior to randomization: a. Methotrexate (within 2 weeks) b. Azathioprine, mycophenolate mofetil, cyclosporine, everolimus, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks) c. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks) d. Intravenous immune globulin (IVIG) (within 8 weeks) e. Corticosteroids (within 4 weeks)
- 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 during screening within 7 days prior to randomization (Visit 1, Day 1)
See the full eligibility criteria
Who can join
- 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. *Documented history of recurrent pericarditis is defined as a prior recurrent pericarditis episode with pericarditic chest pain AND elevated CRP ≥ 1.0 mg/dL.
- Pericarditis pain ≤ 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). **The term “CRP” will be used in this protocol for CRP and high-sensitivity CRP (hs-CRP) analyses performed at local laboratories for the evaluation of eligibility and suspected pericarditis recurrences. If available, hs-CRP is the preferred analysis method to be used.
- Male 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.
- WOCBP*** willing to use an acceptable method of contraception starting with trial therapy 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. Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.
What rules you out
- Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Has received systemic immunomodulatory agents as below prior to randomization: a. Methotrexate (within 2 weeks) b. Azathioprine, mycophenolate mofetil, cyclosporine, everolimus, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks) c. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks) d. Intravenous immune globulin (IVIG) (within 8 weeks) e. Corticosteroids (within 4 weeks)
- 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 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 randomization (Visit 1, Day 1).
- 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 (female) or > 470 msec (male) 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)
- 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)
- Known hypersensitivity to the active substance or any of the excipients of the trial
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. 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 EU CTIS; the study team decides eligibility.