CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
ConditionRecurrent Pericarditis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiol Therapeutics Inc.
About this trial
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 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Eligibility criteria
Qualifiers
Patients 18 years of age or older
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.
Disqualifiers
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 during screening within 7 days prior to randomization (Visit 1, Day 1)
Trial design
Treatments tested in this trial
- CardiolRx
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov