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    Summary
    EudraCT Number:2021-006637-19
    Sponsor's Protocol Code Number:CARDIOL100-002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-07-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-006637-19
    A.3Full title of the trial
    Impact of CardiolRxTM on Myocardial Recovery in Patients with Acute Myocarditis
    A double-blind, placebo-controlled trial (ARCHER)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of CardiolRxTM on Myocardial Recovery in Patients with Acute Myocarditis
    A double-blind, placebo-controlled trial
    A.3.2Name or abbreviated title of the trial where available
    ARCHER
    A.4.1Sponsor's protocol code numberCARDIOL100-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05180240
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCardiol Therapeutics Inc.
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCardiol Therapeutics Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiol Therapeutics Inc.
    B.5.2Functional name of contact pointAndrea Parker
    B.5.3 Address:
    B.5.3.1Street Address2265 Upper Middle Road East, Suite 602
    B.5.3.2Town/ cityOakville
    B.5.3.3Post codeON, L6H 0G5
    B.5.3.4CountryCanada
    B.5.4Telephone number001289910 0850
    B.5.6E-mailandrea.parker@cardiolrx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCardiolRx
    D.3.2Product code CBD
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeCBD
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myocarditis
    E.1.1.1Medical condition in easily understood language
    Acute Myocarditis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000932
    E.1.2Term Acute myocarditis
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of CardiolRx on myocardial recovery in patients presenting with acute myocarditis and to demonstrate that administration of CardiolRx in the proposed doses in this patient population is safe.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of CardiolRxTM on myocardial recovery in patients
    presenting with acute myocarditis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females 18 years of age or older
    2. Diagnosed with acute myocarditis including:
    a) Clinical criteria (symptoms of chest pain, arrhythmia or shortness of
    breath, or history of viral-like illness), preferably followed by elevated
    troponin PLUS
    b) CMR diagnosis (Lake Louise Criteria) within 10 days prior to
    randomization OR
    c) Endomyocardial biopsy (EMB) showing either cellular inflammation
    and/or immunohistochemistry consistent with inflammation.
    3. 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.
    4. Women of childbearing potential willing to use an acceptable method
    of contraception starting with study drug administration and for a
    minimum of 2 months after study completion. Otherwise, women 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 y postmenopausal) or be surgically
    sterile. The following reliable methods of contraception are: parenteral
    E.4Principal exclusion criteria
    1. Coronary artery disease (CAD) defined as a stenosis greater than
    50% in a major epicardial coronary artery
    2. Severe valvular heart disease
    3. Inability to safely undergo CMR including administration of
    gadolinium
    4. Estimated glomerular filtration rate (eGFR) < 30 ml/min
    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.
    6. Sepsis, defined as documented bacteremia at the time of
    presentation or other documented active infection.
    7. Severe left ventricular (LV) dysfunction - requiring inotropic
    support, left ventricular assist device (LVAD) or other circulatory
    assist devices, or urgent need for transplantation
    8. Documented biopsy evidence of giant cell or eosinophilic
    myocarditis
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of this study is comprised of two primary
    endpoints, i.e., the difference in the means of each: ECV and GLS, as
    measured byCMR at 12 weeks post randomization between the active
    and the placebo groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    - The secondary outcome of this study is the difference in the means of
    left-ventricular ejection fraction (LVEF), as measured by CMR at 12
    weeks post randomization between the active and the placebo groups.

    Other Efficacy Outcomes:
    - Survival, free from major event (cardiac transplant, left-ventricular
    assist device (LVAD), hospitalization for heart failure (HF)) through 12
    weeks post randomization
    - Change in CMR parameters from baseline to 12 weeks post
    randomization: LVEF, ECV, GLS, left ventricular end-diastolic volume
    (LVEDV), left ventricular end-systolic volume (LVESV), left atrial endsystolic
    volume (LAESV), LV mass, late gadolinium enhancement (LGE)
    imaging, degree of edema
    - Change in New York Heart Association (NYHA) classification from
    baseline to 12 weeks post randomization
    - Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from
    baseline to 12 weeks post randomization
    - Time to resolution of clinical symptoms, including chest pain,
    arrhythmias, shortness of breath
    - Time to normalization of high sensitivity troponin (hs-troponin), Nterminal
    pro B-type naturetic peptide (NT-proBNP) and inflammatorymarkers: high sensitivity C reactive protein (hs-CRP), ferritin, tumour
    necrosis factor alpha (TNF-alpha), interleukin 1-beta (IL-1 beta),
    interleukin 6 (IL-6), interleukin 10 (IL-10), inerleukin 18 (IL-18) and
    endothelial markers: soluble vascular cell adhesion molecule-1 (sVCAM-
    1), transforming growth factor beta (TGF-beta [beta 1 and beta 2])
    - Change in hs-troponin, NT-proBNP and inflammatory markers (hs-CRP,
    ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10, IL-18 and endothelial markers
    (sVCAM-1, TGF-beta [beta 1 and beta 2])) from baseline to week 12 post
    randomization
    - Time to normalization of electrocardiogram (ECG) abnormalities
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    Israel
    United States
    France
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of Care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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