CardiolRx for Pericarditis

(MAVERIC Trial)

Recruiting at 27 trial locations

Overseen By Heather Dalgleish, MSc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cardiol Therapeutics Inc.

Must be taking: IL-1 blockers

Must not be taking: Cannabinoids, Methotrexate

Disqualifiers: Cancer, Sepsis, Myocarditis, others

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: 2

Duration: 24 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CardiolRx for individuals with recurrent pericarditis, a condition where the sac around the heart becomes inflamed repeatedly. The goal is to determine if participants can remain free of pericarditis flare-ups while taking CardiolRx after stopping their current IL-1 blocker medication. Participants should have managed their pericarditis with an IL-1 blocker for at least a year and remained stable without flare-ups for at least six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

Participants will need to stop taking their IL-1 blocker as part of the trial. The trial does not specify if other medications need to be stopped, but certain immunomodulatory agents must not have been used recently before joining the trial.

Is there any evidence suggesting that CardiolRx is likely to be safe for humans?

Studies have shown that CardiolRx is safe and well tolerated. In earlier trials with patients who had serious health issues, CardiolRx did not cause major safety problems. Participants managed the treatment well, with no significant side effects.

These findings suggest that CardiolRx could be a good option for those considering joining a trial, as the treatment appears safe based on previous research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CardiolRx for pericarditis because it offers a potential new approach by utilizing cannabidiol (CBD) as its active ingredient. Unlike standard treatments like NSAIDs, colchicine, or corticosteroids, which primarily focus on reducing inflammation, CardiolRx targets both inflammation and the underlying processes that contribute to the condition, potentially offering a more comprehensive benefit. Additionally, CardiolRx is administered in a gradually increasing dose regimen, which might help optimize its effectiveness and minimize side effects, making it a promising alternative for those who may not respond well to current treatments.

What evidence suggests that CardiolRx might be an effective treatment for pericarditis?

Research has shown that CardiolRx, which participants in this trial may receive, offers promising results for people with recurring pericarditis. Earlier studies found that CardiolRx significantly reduced pain and swelling reported by patients. The treatment proved safe and easy to tolerate, which is important for long-term use. These findings suggest that CardiolRx could help prevent future episodes of pericarditis, offering hope to those affected by this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul Cremer, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

I have had chest pain from pericarditis rated 2 or higher for the last week.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive double-blind trial therapy with CardiolRx or placebo for 24 weeks

24 weeks

Regular visits as per trial protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

A new semi-mechanistic modeling platform was developed to assess cardiovascular safety by evaluating changes in contractility, heart rate, and mean arterial pressure in preclinical studies using data from 27 dogs and various drugs.

The model effectively accounted for factors like preload effects on heart contractility, allowing for a comprehensive evaluation of drug-induced cardiovascular changes, which is crucial for ensuring the safety of new medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semi-mechanistic modelling platform to assess cardiac contractility and haemodynamics in preclinical cardiovascular safety profiling of new molecular entities. Venkatasubramanian, R., Collins, TA., Lesko, LJ., et al.[2021]

Analysis of the FAERS database revealed that hydroxychloroquine (HCQ) and chloroquine (CQ) are associated with a higher reporting rate of serious cardiovascular adverse events (CVAEs), including cardiomyopathy, QT prolongation, cardiac arrhythmias, and heart failure, with significant odds ratios indicating increased risk.

CVAEs related to HCQ/CQ treatment resulted in hospitalization rates of 39% and mortality rates of 8%, highlighting the need for caution when prescribing these medications, especially in patients with pre-existing cardiac conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre-COVID-19 reports. Goldman, A., Bomze, D., Dankner, R., et al.[2022]

The OMERACT initiative aims to create a standardized tool for reporting adverse events in rheumatology clinical trials, which will help ensure consistent terminology and severity assessment across studies.

The proposed Rheumatology Common Toxicity Criteria Index covers multiple organ systems, but its effectiveness and practicality must be validated in clinical trials before widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. Woodworth, TG., Furst, DE., Strand, V., et al.[2007]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

Citations

1. cardiolrx.com cardiolrx.com/cardiol-therapeutics-announces-positive-topline-data-from-its-phase-ii-maveric-pilot-study-investigating-cardiolrx-for-recurrent-pericarditis/

Cardiol Therapeutics Announces Positive Topline Data ... The data showed a substantial reduction in the primary efficacy endpoint of patient-reported pericarditis pain at the end of the 8-week ...

2. cardiolrx.com cardiolrx.com/cardiol-therapeutics-phase-ii-maveric-pilot-clinical-results-in-recurrent-pericarditis-presented-at-the-american-heart-association-scientific-sessions-2024/

Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical ... “The compelling results from MAvERIC-Pilot showed that CardiolRx™ resulted in marked and rapid reductions in pericarditis pain and inflammation ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05494788

Study Details | NCT05494788 | Impact of CardiolRxTM on ... This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures ...

4. myocarditisfoundation.org myocarditisfoundation.org/wp-content/uploads/2025/05/MF-Cardiol-Therapeutics-Enrolls-First-Patient-in-Pivotal-Phase-III-MAVERIC-Trial-in-Recurrent-Pericarditis-Press-Release-April-16-2025.pdf

Cardiol Therapeutics Enrolls First Patient in Pivotal Phase ... Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern ...

5. cardiolrx.com cardiolrx.com/cardiol-therapeutics-announces-topline-results-from-the-phase-ii-archer-trial-of-cardiolrx-in-acute-myocarditis/

Cardiol Therapeutics Announces Topline Results from the ... Consistent with findings from Cardiol's Phase II MAvERIC trial in recurrent pericarditis, CardiolRx™ was shown to be safe and well tolerated.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06708299

CardiolRx in Recurrent Pericarditis Following IL-1 Blocker ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

7. cardiolrx.com cardiolrx.com/cardiol-therapeutics-to-advance-cardiolrx-into-a-late-stage-trial-in-patients-with-recurrent-pericarditis/

Cardiol Therapeutics to Advance CardiolRx™ into a Late- ... There is a growing body of evidence indicating pericarditis recurrence rates are as high as seventy-five percent and onset is rapid following ...