Recurrent PericarditisPhase 3MAVERICNCT06708299
CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
A Phase 3 study testing CardiolRx in people with Recurrent Pericarditis, run by Cardiol Therapeutics Inc. at 27 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pericarditis
- What is being tested?
- CardiolRx
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 7 Apr 2025to 21 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- 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.
- 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)
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- C-Reactive Protein (CRP) < 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
- 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.
- 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.
Who cannot join
- Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
- 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)
- Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
- Estimated glomerular filtration rate (eGFR) < 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
- 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).
- Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection*
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- Prior history of sustained ventricular arrhythmia(s)
- History of diagnosed long QT syndrome
- 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)
- 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)
- 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
- Inability or unwillingness to give informed consent
- Ongoing drug or alcohol abuse in the opinion of the investigator
- On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
- Pregnant or breastfeeding
- Current diagnosis of active cancer, with the exception of non-melanoma skin cancer
- Any factor, which would make it unlikely that the patient can comply with the trial procedures
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Has received systemic immunomodulatory agents as below prior to randomization:
- Methotrexate (within 2 weeks)
- Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)
- Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)
- Intravenous immune globulin (IVIG) (within 8 weeks)
- Corticosteroids (within 4 weeks)
- Known hypersensitivity to the active substance or any of the excipients of the trial
Trial locations and contacts
27 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 4 countries
United States21 sites, 21 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Luigi Adamo, MD, ladamo2@jhmi.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jonathan Salik, MD, jsalik@mgh.harvard.edu
- Recruiting
University of Vermont
Burlington, Vermont, 05401
Tracy Hagerty, MD, tracy.hagerty@uvmhealth.org
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Antonio Abbate, MD, antonio.abbate@virginia.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60208
Mohammed Al-Kazaz, MD, mohamed.alkazaz@nm.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Saberio Lo Presti Vega, MD, LOPRESS2@ccf.org
- Recruiting
MedStar Health Institute
Columbia, Maryland, 21044
Syed Haider, MD, Waqas.Haider@medstar.net
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Maan Malahfji, MD
- Recruiting
UCI Health
Irvine, California, 92697
Amin Sabet, MD, sabeta1@hs.uci.edu
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Prajwal Reddy, MD, reddy.prajwal@mayo.edu
- Recruiting
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Ajit Raisinghani, MD, araisinghani@health.ucsd.edu
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Paul Marano, MD, Paul.Marano@cshs.org
- Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
David Lin, MD, David.Lin@allina.com
- Recruiting
NYU Langone Health
New York, New York, 10016
Michael Garshick, MD, michael.garshick@nyulangone.org
- Recruiting
Columbia University - New York Presbyterian
New York, New York, 10032
Dor Lotan, MD, dl3491@cumc.columbia.edu
- Recruiting
Lenox Hill Hospital
New York, New York, 11030
Dennis Finkielstein, MD, DFinkielstei@northwell.edu
- Recruiting
Mayo Clionic Arizona
Phoenix, Arizona, 85054
Chadi Ayoub, MD, ayoub.chadi@mayo.edu
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
Georgia Thomas, MD, georgia.thomas@vcuhealth.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sushil A Luis, MD, luis.s@mayo.edu
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84112
Libo Wang, MD, Libo.Wang@utah.edu
- Recruiting
Pacific Heart Institute at Cedars-Sinai
Santa Monica, California, 90404
Rigved Tadwalker, MD, rtadwalkar@pacificheart.com
Italy4 sites, 4 recruiting
- Not yet recruiting
Fatebenefratelli Hospital Milano
Milan
Antonio Brucato, MD, antonio.brucato@unimi.it
- Not yet recruiting
University of Padua
Padua
Alida Caforio, MD, alida.caforio@unipd.it
- Not yet recruiting
University Hospital
Torino
Alessandro Andreis, MD, alessandro.andreis@unito.it
- Not yet recruiting
University Hospital Udine
Udine
Valentino Collini, MD, valentino.collini@asufc.sanita.fvg.it
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal
Vartan Mardigyan, MD, vartan.mardigyan@mail.mcgill.ca
Greece1 site, 1 recruiting
- Recruiting
Hippokration General Hospital
Athens
George Lazaros, MD, glaz35@hotmail.com
About this study
Official title: CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled 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 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Read the detailed description
Double-blind, randomized, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Before any trial-related procedure is performed, written informed consent will be obtained. After informed consent is obtained, patients will be screened for eligibility.
The highest NRS pain score within the past 7 days is to be assessed prior to randomization at Visit 1 (Day 1). Baseline blood samples for central laboratory assessment of hs-CRP and pharmacokinetic assessments should also be collected prior to randomization at Visit 1 (Day 1).
All other screening assessments will be performed at any time within 7 days prior to randomization at Visit 1 (Day 1) and include the following: Physical examination, vital signs, 12-lead ECG; C-SSRS and blood draws for local laboratory assessments (see Section 17.2).
Eligible patients will be randomized at Visit 1 (Day 1) to either CardiolRx or matching placebo in a 1:1 ratio. Double-blind trial therapy will be initiated in the evening of Day 1, 10 - 16 days (no additional time window is allowed) prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks.
Vital signs, ECG recording and blood draws for local and central laboratory analyses will be carried out at selected visits. Concomitant medications and (S)AEs will be recorded at all visits.
Final efficacy assessments will take place at Visit 9, 24 weeks after randomization and start of trial therapy and include a physical exam, vital signs, pain score NRS collection, a 12-lead ECG, a C-SSRS, as well as blood draws for local and central laboratory assessments.
A virtual safety follow-up visit (Visit 10) will be scheduled 4 weeks after the last trial therapy administration.
- Conditions
- Recurrent Pericarditis
- Being tested
- CardiolRx
- Keywords
- IL-1 blocker-dependent recurrent pericarditis, pharmaceutically cannabidial
- Medical subject headings
- Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiolRxDrug
Also called Pharmaceutically produced cannabidiol
The intervention will be administered orally (via syringe) with food twice daily.
| Study group | Role | What they receive |
|---|---|---|
| CardiolRx | Active comparator | * 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. Receives: Drug: CardiolRx |
| Placebo | Placebo comparator | * 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. Receives: Drug: CardiolRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to pericarditis recurrence
time to a new episode of recurrent pericarditis* from the timepoint of stopping the IL-1 blocker to Week 24
Measured: 24 weeks
Secondary outcomes (2)
Proportions of patients free from a new episode of recurrent pericarditis
Proportions of patients free from a new episode of recurrent pericarditis from the timepoint of stopping the IL-1 blocker to week 24
Measured: 24 weeks
Percentage of days with no or minimal pain
The percentage of days with no or minimal pain as assessed by an NRS score ≤ 2 from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start7 Apr 2025
- Primary completion21 Sep 2026 (estimated)
- Study completion21 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent PericarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiol Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Cremer, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708299
- Sponsor's protocol ID
- Cardiol 100-006
- Acronym
- MAVERIC
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Imazio M, Klein AL, Brucato A, Abbate A, Arad M, Cremer PC, Insalaco A, LeWinter MM, Lewis BS, Lin D, Luis SA, Nicholls SJ, Sutej P, Wasserstrum Y, Clair J, Agarwal I, Wang S, Paolini JF; RHAPSODY Investigators. Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept. J Am Heart Assoc. 2024 Mar 19;13(6):e032516. doi: 10.1161/JAHA.123.032516. Epub 2024 Mar 12.
PubMed 38471825M Imazio, L Trotta, E Bizzi, M Pancrazi, S Wang, J Clair, A L Klein, E Tombetti, A Brucato, J F Paolini, RHAPSODY Investigators, Multi-year recurrent pericarditis disease duration in Italian patients: clinical outcomes after cessation of long-term IL-1 pathway inhibition provide insights for chronic management, European Heart Journal, Volume 45, Issue Supplement_1, October 2024, ehae666.2104, https://doi.org/10.1093/eurheartj/ehae666.2104
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06708299
- Acronym / sponsor ID
- MAVERIC / Cardiol 100-006
- Conditions
- Recurrent Pericarditis
- Keywords
- IL-1 blocker-dependent recurrent pericarditis, pharmaceutically cannabidial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cardiol Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 21 Oct 2026 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Detailed description
Double-blind, randomized, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Before any trial-related procedure is performed, written informed consent will be obtained. After informed consent is obtained, patients will be screened for eligibility.
The highest NRS pain score within the past 7 days is to be assessed prior to randomization at Visit 1 (Day 1). Baseline blood samples for central laboratory assessment of hs-CRP and pharmacokinetic assessments should also be collected prior to randomization at Visit 1 (Day 1).
All other screening assessments will be performed at any time within 7 days prior to randomization at Visit 1 (Day 1) and include the following: Physical examination, vital signs, 12-lead ECG; C-SSRS and blood draws for local laboratory assessments (see Section 17.2).
Eligible patients will be randomized at Visit 1 (Day 1) to either CardiolRx or matching placebo in a 1:1 ratio. Double-blind trial therapy will be initiated in the evening of Day 1, 10 - 16 days (no additional time window is allowed) prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks.
Vital signs, ECG recording and blood draws for local and central laboratory analyses will be carried out at selected visits. Concomitant medications and (S)AEs will be recorded at all visits.
Final efficacy assessments will take place at Visit 9, 24 weeks after randomization and start of trial therapy and include a physical exam, vital signs, pain score NRS collection, a 12-lead ECG, a C-SSRS, as well as blood draws for local and central laboratory assessments.
A virtual safety follow-up visit (Visit 10) will be scheduled 4 weeks after the last trial therapy administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomized
| Arm | Type | Receives |
|---|---|---|
| CardiolRx | Active comparator | Drug: CardiolRx* 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. |
| Placebo | Placebo comparator | Drug: CardiolRx* 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients 18 years of age or older
- 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:
- 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)
- C-Reactive Protein (CRP) < 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
- 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.
Key exclusion criteria (25 listed)
- Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
- 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)
- Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
- Estimated glomerular filtration rate (eGFR) < 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardiolRxAlso: Pharmaceutically produced cannabidiolThe intervention will be administered orally (via syringe) with food twice daily. | Drug | CardiolRx, Placebo |
Primary outcome
time to pericarditis recurrence
Time frame: 24 weeks
time to a new episode of recurrent pericarditis* from the timepoint of stopping the IL-1 blocker to Week 24
2 secondary outcomes
Proportions of patients free from a new episode of recurrent pericarditis
Time frame: 24 weeks
Percentage of days with no or minimal pain
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 38471825Imazio M, Klein AL, Brucato A, Abbate A, Arad M, Cremer PC, Insalaco A, LeWinter MM, Lewis BS, Lin D, Luis SA, Nicholls SJ, Sutej P, Wasserstrum Y, Clair J, Agarwal I, Wang S, Paolini JF; RHAPSODY Investigators. Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept. J Am Heart Assoc. 2024 Mar 19;13(6):e032516. doi: 10.1161/JAHA.123.032516. Epub 2024 Mar 12.
- BackgroundM Imazio, L Trotta, E Bizzi, M Pancrazi, S Wang, J Clair, A L Klein, E Tombetti, A Brucato, J F Paolini, RHAPSODY Investigators, Multi-year recurrent pericarditis disease duration in Italian patients: clinical outcomes after cessation of long-term IL-1 pathway inhibition provide insights for chronic management, European Heart Journal, Volume 45, Issue Supplement_1, October 2024, ehae666.2104, https://doi.org/10.1093/eurheartj/ehae666.2104
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Cremer, MD principal investigator
Northwestern University
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CardiolRx in people with Recurrent Pericarditis, run by Cardiol Therapeutics Inc. at 27 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Italy, Canada, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea B Parker, MSc., PhD (+1 289 910 0862, andrea.parker@cardiolrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to pericarditis recurrence (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708299, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.