The primary efficacy endpoint of the trial will be the change in patient-reported pericarditis pain. Credit: Ali Hajiluyi on Unsplash.

Cardiol Therapeutics has enrolled the first participant in the Phase II clinical trial of CardiolRx to treat recurrent pericarditis.

The company-sponsored, open-label pilot study has been designed for evaluating the efficacy, tolerance, and safety of CardiolRx in recurrent pericarditis patients.

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It will also assess the feasibility of weaning concomitant background therapy, such as corticosteroids, along with improvement in objective measures of disease, while taking CardiolRx.

In this trial, 25 participants are anticipated to be enrolled at the US clinical centres, which are specialised in pericarditis care.

The company stated that the protocol of the study is designed in partnership with leaders in pericardial disease.  

The change in patient-reported pericarditis pain measured using an 11-point numeric rating scale (NRS) from baseline to eight weeks is the trial’s primary efficacy endpoint.

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Changes in C-reactive protein circulating levels and the pain score after 26 weeks of treatment are some of the secondary endpoints of the trial.

The Cleveland Clinic recruited the first subject in the study.

Cleveland Clinic Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cardiologist Dr Paul Cremer said: “We are excited to be the first clinical centre to administer this investigational drug in a patient with recurrent pericarditis, a debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity.

“Along with other collaborating research centres throughout the US, we look forward to full enrolment of participants into this pilot study and to determining the potential of this therapy to treat pericarditis and to reduce the risk of its recurrence.”

The pharmaceutically manufactured oral solution formulation CardiolRx (cannabidiol) is being clinically developed for heart diseases use.