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Cannabidiol

CardiolRx for Myocarditis (ARCHER Trial)

Phase 2

Recruiting

Research Sponsored by Cardiol Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with acute myocarditis including clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness) preferably followed by elevated troponin PLUS CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation

Male subjects with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug

Must not have

Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8

Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks post randomization

Summary

This trial is testing a new drug, CardiolRx, to see if it can help people with myocarditis.

Who is the study for?

Adults diagnosed with acute myocarditis, confirmed by clinical symptoms and CMR or biopsy, can join this trial. Participants must agree to use contraception if necessary. Excluded are those with severe heart issues, recent heart procedures, drug/alcohol abuse, pregnant/breastfeeding women, certain other medical conditions or treatments.

What is being tested?

The trial is testing CardiolRx (a THC-free Cannabidiol) against a placebo in patients with myocarditis over a period of 12 weeks. It's double-blind and randomized: neither doctors nor patients know who gets the real medicine. They'll check heart health using scans and various tests.

What are the potential side effects?

While specific side effects for CardiolRx aren't listed here, typical cannabidiol side effects may include tiredness, diarrhea, changes in appetite/weight. Since it's free of THC (<5 ppm), psychoactive effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with acute myocarditis, confirmed by specific heart tests or biopsy.

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I am a man who will use double barrier contraception or have had a vasectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking medication that strongly affects certain liver enzymes.

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I currently have an infection in my blood or another active infection.

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I need help for my heart to pump blood, like a device or medicine.

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I cannot safely have an MRI with contrast.

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I am currently taking medication for heart rhythm problems.

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I have a cancer diagnosis, not including non-melanoma skin cancer.

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My body weight is over 170 kg.

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My kidney function is severely reduced.

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I have severe heart valve disease.

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I had a procedure to open blocked arteries in my heart within the last 30 days.

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I am not pregnant or breastfeeding.

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I have a blockage in a major heart artery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global longitudinal Strain (GLS)

extracellular volume (ECV)

Secondary study objectives

Left-ventricular ejection fraction (LVEF)

Other study objectives

Change in CMR parameters (%)

Change in CMR parameters (g/m2)

Change in CMR parameters (mL/m2)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CardiolRxExperimental Treatment1 Intervention

* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CardiolRx

2022

Completed Phase 2

~30

0 / 14Eligibility criteria met