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New hope for heart lining pain: can CardiolRx keep flare-ups away?

NCT ID NCT06708299

Disease control Sponsor: Cardiol Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests whether the drug CardiolRx can prevent another episode of pericarditis (inflammation around the heart) in people who have had repeated attacks. About 110 adults who have been stable on an IL-1 blocker for at least a year will stop that medication and receive either CardiolRx or a placebo for 24 weeks. The goal is to see if CardiolRx helps them stay free of recurrence.

Why investors are watching

Cardiol Therapeutics is testing CardiolRx, an experimental drug, in a phase 3 trial for recurrent pericarditis, a condition where the heart's lining becomes inflamed and painful. The trial enrolls 110 patients who are stopping a standard IL-1 blocker, and the goal is to see if CardiolRx keeps them free of recurrence for 24 weeks. For a micro-cap company with few products, this readout is a major event because a positive result could support a new treatment approval, while a negative one would leave the company without a clear path forward.

If it works: If the trial succeeds, Cardiol Therapeutics could have a new, oral treatment option for a chronic heart condition with limited therapies. That result would likely strengthen the company's position with regulators and potential partners.

If it fails: Phase 3 trials often fail, and this one has a small patient group, which makes the outcome less certain. A failure or delay would be a serious setback for a company of this size, potentially leaving it without a viable product candidate.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients 18 years of age or older 2. A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as: * treatment with an IL-1 blocker for at least 12 months, * free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of an IL-1 blocker; and * treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization. 3. Pericarditis pain les or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least 7 days prior to randomization (Visit 1, Day 1) 4. C-Reactive Protein (CRP) \< 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1). 5. Patients who have had a vasectomy or who are willing to use double barrier contraception methods with partners of childbearing potential during the conduct of the trial and for 2 months after the last dose of trial therapy. 6. Patients of childbearing potential willing to use an acceptable method of contraception starting with trial therapy administration and for a minimum of 2 months after trial completion. Otherwise, these patients must be postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥ 40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 years postmenopausal) or be surgically sterile. Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence. Exclusion Criteria: 1. Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker 2. Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); systemic autoimmune disease (e.g., systemic lupus erythematosus) 3. Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted) 4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1) 5. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (ULN) or ALT or AST \> 3x ULN plus bilirubin \> 2x ULN during screening within 7 days prior to randomization (Visit 1, Day 1). 6. Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection\* 7. Prior history of sustained ventricular arrhythmia(s) 8. History of diagnosed long QT syndrome 9. QTc interval \> 480 msec (biologically female) or \> 470 msec (biologically male) (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction) or second or third degree atrioventricular (AV) block in a patient without an implanted functioning pacemaker device during screening within 7 days prior to randomization (Visit 1, Day 1) 10. Showing suicidal tendency during the last 12 months, as defined by answering "yes" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered during screening within 7 days prior to randomization (Visit 1, Day 1) 11. Participation in a clinical trial in which an investigational drug or device was administered within 30 days of screening or within 5 half-lives of the previous study drug, whichever is longer 12. Inability or unwillingness to give informed consent 13. Ongoing drug or alcohol abuse in the opinion of the investigator 14. On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial 15. Pregnant or breastfeeding 16. Current diagnosis of active cancer, with the exception of non-melanoma skin cancer 17. Any factor, which would make it unlikely that the patient can comply with the trial procedures 18. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment 19. Has received systemic immunomodulatory agents as below prior to randomization: 1. Methotrexate (within 2 weeks) 2. Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks) 3. Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks) 4. Intravenous immune globulin (IVIG) (within 8 weeks) 5. Corticosteroids (within 4 weeks) 20. Known hypersensitivity to the active substance or any of the excipients of the trial

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Conditions

The condition(s) this trial relates to.

idiopathic recurrent pericarditis pericarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent pericarditis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Altman Clinical and Translational Research Institute

    RECRUITING

    La Jolla, California, 92037, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University - New York Presbyterian

    RECRUITING

    New York, New York, 10032, United States

  • Fatebenefratelli Hospital Milano

    NOT_YET_RECRUITING

    Milan, Italy

  • Hippokration General Hospital

    RECRUITING

    Athens, Greece

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Jewish General Hospital

    RECRUITING

    Montreal, Canada

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Lenox Hill Hospital

    RECRUITING

    New York, New York, 11030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clionic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • MedStar Health Institute

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60208, United States

  • Pacific Heart Institute at Cedars-Sinai

    RECRUITING

    Santa Monica, California, 90404, United States

  • UCI Health

    RECRUITING

    Irvine, California, 92697, United States

  • University Hospital

    NOT_YET_RECRUITING

    Torino, Italy

  • University Hospital Udine

    NOT_YET_RECRUITING

    Udine, Italy

  • University of Padua

    NOT_YET_RECRUITING

    Padua, Italy

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Vermont

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.