CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation
NCT ID: NCT06708299
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
110 participants
INTERVENTIONAL
2025-04-07
2026-10-21
Brief Summary
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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 who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
CardiolRx
The intervention will be administered orally (via syringe) with food twice daily.
Placebo
* 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.
CardiolRx
The intervention will be administered orally (via syringe) with food twice daily.
Interventions
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CardiolRx
The intervention will be administered orally (via syringe) with food twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Cardiol Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Cremer, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Mayo Clionic Arizona
Phoenix, Arizona, United States
UCI Health
Irvine, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
MedStar Health Institute
Columbia, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Columbia University - New York Presbyterian
New York, New York, United States
Columbia University - New York Presbyterian
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Jewish General Hospital
Montreal, , Canada
Hippokration General Hospital
Athens, , Greece
Fatebenefratelli Hospital Milano
Milan, , Italy
University of Padua
Padua, , Italy
University Hospital
Torino, , Italy
University Hospital Udine
Udine, , Italy
Countries
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Central Contacts
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Facility Contacts
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Amin Sabet, MD
Role: primary
Prajwal Reddy, MD
Role: primary
Luigi Adamo, MD
Role: primary
Syed Haider, MD
Role: primary
Dor Lotan, MD
Role: primary
Dennis Finkielstein, MD
Role: primary
Maan Malahfji, MD
Role: primary
Libo Wang, MD
Role: primary
References
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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.
M 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
Other Identifiers
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Cardiol 100-006
Identifier Type: -
Identifier Source: org_study_id
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