CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation (MAVERIC)

CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation (MAVERIC)

Status: Not yet recruiting

Conditions: Pericarditis

Location:

Cleveland Clinic
Massachusetts General Hospital
Mayo Clinic in Rochester
Northwestern University Medicine
University of Virginia

City/State:

Chicago, Illinois


Boston, Massachusetts


Rochester, Minnesota


Cleveland, Ohio


Charlottesville, Virginia

Contact Information:

Name: Andrea B Parker, MSc., PhD
Phone Number: +1 289 910 0862
Email: [email protected]


Name: Heather Dalgleish, MSc.
Phone Number:+1 289 910 0384
Email: [email protected]

Brief 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.

Detailed Description: 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.

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