CardiolRx for Pericarditis

(MAVERIC Trial)

Recruiting at 6 trial locations

Overseen By Heather Dalgleish, MSc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cardiol Therapeutics Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

110 Participants Needed

Trial Summary

What is the purpose of 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 - 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.

Research Team

Paul Cremer, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with recurrent pericarditis who have been on an IL-1 blocker for at least a year and are planning to stop the medication. They will be part of a study that tests if CardiolRx can prevent their pericarditis from coming back after stopping the IL-1 blocker.

Inclusion Criteria

C-Reactive Protein (CRP) less than 1.0 mg/dL within the 7 days of screening prior to Day 1 (Visit 1)

I am 18 years old or older.

I have recurring pericarditis, currently managed with an IL-1 blocker, which I plan to stop.

Exclusion Criteria

QTc interval greater than 500 msec at baseline

Pregnant or breastfeeding

On any cannabinoid during the past month and unwilling to stay abstinent from all cannabis products for the duration of the trial

Treatment Details

Interventions

• CardiolRx

Trial Overview The trial is testing CardiolRx, given before and after discontinuing an IL-1 blocker treatment. It's a multi-center, double-blind (neither doctors nor participants know who gets what), placebo-controlled study lasting 24 weeks to see if it prevents pericarditis recurrence.

Participant Groups

Group I: CardiolRx Active Control 1 Intervention

* Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight CardiolRx b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight CardiolRx b.i.d.

Group II: Placebo Placebo Group 1 Intervention

* Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight matching placebo b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight matching placebo b.i.d.

Who Is Running the Clinical Trial?

Cardiol Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

330+