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    Summary
    EudraCT Number:2018-003472-13
    Sponsor's Protocol Code Number:MYTH-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003472-13
    A.3Full title of the trial
    Myocarditis Therapy with IL-1 inhibitor (MYTH-1): a double-blind, phase IIa, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of anakinra in addition to standard of care for the treatment of virusnegative myocarditis
    Terapia della Miocardite con inibitore di IL-1 (MYTH-1): studio in doppio cieco, di fase IIa, randomizzato, controllato verso placebo per valutare efficacia e sicurezza di anakinra in aggiunta a standard di cura rispetto allo standard di cura per il trattamento della miocardite virus negativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Virus-negative myocarditis(VNM) is a life-threatening disease with elusive pathogenesis and no proven treatment. The pro-inflammatory cytokine interleukin-1(IL-1) is central to the inflammatory response underlying myocartidis. We propose a clinical trial to evaluate the efficacy and safety of anakinra in addition to standard of care in the treatment of VNM. IL-1 inhibition is expected to afford clinically relevant benefits, preventing long-term heart damage and dysfunction
    Terapia della Miocardite con inibitore di IL-1 (MYTH-1): studio in doppio cieco, di fase IIa, randomizzato, controllato verso placebo per valutare efficacia e sicurezza di anakinra in aggiunta a standard di cura rispetto allo standard di cura per il trattamento della miocardite virus negativa
    A.3.2Name or abbreviated title of the trial where available
    Myocarditis Therapy with IL-1 inhibitor (MYTH-1)
    Terapia della Miocardite con inibitore di IL-1 (MYTH-1)
    A.4.1Sponsor's protocol code numberMYTH-1
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistero della Salute
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportSOBI
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS San Raffaele
    B.5.2Functional name of contact pointUnità di Immunologia, Reumatologia,
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226433549
    B.5.6E-maildeluca.giacomo@hsr.it
    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 Yes
    D.2.1.1.1Trade name KINERET 100 mg/0,67 ml soluzione iniettabile uso sc siringhe preriempite
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameKINERET
    D.3.2Product code [035607062]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.2Current sponsor codeMYTH-1
    D.3.9.3Other descriptive nameInterleukin1 receptor antagonist
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Endomyocardial biopsy proven virus-negative myocarditis with left ventricular ejection fraction lower than 55%.
    La miocardite virus-negativa è una patologia infiammatoria che coinvolge il miocardio. E' diagnosticata con biopsia endomiocardica su base istologica, immunologica ed immunoistochimica e in assenza di genoma virale identificabile. L’infiammazione miocardica acuta causa flogosi subacuta e cronica, formazione di tessuto fibrotico, disfunzione contrattile e cardiomiopatia dilatativa (30% dei casi) condizioni che portano a complicanze aritmiche, con possibile morte cardiaca improvvisa.
    E.1.1.1Medical condition in easily understood language
    Virus-negative myocarditis with decreased cardiac function.
    La miocardite virus-negativa è una patologia infiammatoria cronica che coinvolge il miocardio, può portare a disfunzione contrattile e cardiomiopatia dilatativa con possibile morte cardiaca improvvisa
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10064539
    E.1.2Term Autoimmune 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 efficacy of Anakinra in addition to standard immunosuppressive therapy at improving Left Ventricular Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE) at 2 months.
    Valutare l’efficacia di Anakinra in associazione alla terapia immunosoppressiva standard con prednisone + azatioprina nel migliorare la frazione d’eiezione ventricolare sinistra (LVEF) valutata mediante ecocardiografia transtoracica (TTE) a 2 mesi.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Anakinra in reducing venricular arrhythmias on 24h-ECG Holter at 3 different time points: 2 weeks, 2 months and 6 months. To evaluate the efficacy of Anakinra in improving Left Ventricular Ejection Fraction(LVEF) at 2 weeks and at 6 months and to imprrove LV volumes and diameters at 3 different time points(2 weeks, 2 months and 6 months). To evaluate the efficacy of Anakinra in preventing myocarditis complications (ventricular arrhythmias, heart failure, chest pain, syncope) and decreasing Cardiovascular deaths rate at 2 weeks, 2 months and 6 months.
    To assess the ability of Anakinra in improving patient's symptoms (New York Heart Association dyspnea class), quality of life ( patients reported outcomes), cardiac enzymes and inflammatory markers at 2 weeks, 2 months and 6 months. To evaluate the safety of anakinra in the treatment of myocarditis at 4 different time points: baseline, 2 weeks, 2 months and at 6 months.
    Valutare l’efficacia di Anakinra nel: ridurre le aritmie all'ECG-Holter 24h a 3 differenti time points(2 settimane,2 mesi e 6 mesi); migliorare la frazione d’eiezione ventricolare sinistra(LV-EF) a 2 settimane e 6 mesi; modificare i volumi e i diametri del ventricolo sinistro; migliorare la qualità di vita dei pazienti affetti da miocardite(determinata con Patients Reported Outcomes); migliorare i sintomi da scompenso cardiaco valutati mediante la classe funzionale New York Heart Association a 3 differenti time points(2 settimane,2 mesi e 6 mesi); ridurre i livelli sierici di NT-proBNP, di troponina, degli indici di flogosi sistemica(VES,PCR) e citochine pro-infiammatorie;migliorare la LV-EF valutata con risonanza magnetica nucleare a 6 mesi; ridurre le complicanze da miocardite (aritmie ventricolari, scompenso cardiaco, sincope, dolore toracico); ridurre il tasso di mortalità a 6 mesi; valutare la sicurezza di Anakinra a 4 differenti time points(baseline,2 settimane,2 mesi e 6 mesi).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 Years to 75 Years. Myocarditis defined on endomyocardial biopsy according to Dallas criteria and to immunohistochemical criteria (CD3+ >7/mm2). Any impairment of left ventricular ejection fraction (LV-EF) <55% on Trans Thoracic Echocardiography. Ability to sign an informed consent.
    Età tra i 18 e i 75 anni (sia maschi che femmine); diagnosi di miocardite definita su EBM (effettuata prima dell’arruolamento nello studio, come da pratica clinica) in accordo ai criteri di Dallas e immunoistochimici (CD3+ >7/mm2); compromissione della funzionalità contrattile del ventricolo sinistro definita come LV-EF <55% al TTE; capacità di firmare il consenso informato.
    E.4Principal exclusion criteria
    Coronary artery stenosis > 50% at angiography or coronary CT Scan (acceptable if performed during the last 12 months). Evidence of genome of cardiotropic viruses by Polymerase chain reaction on EBM. Clinical suspicion or proven underlying disease: Lyme disease, any other bacterial disease possibly responsible for myocarditis, trypanosomiase disease, giant cell myocarditis. Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Pregnancy, breastfeeding. Female patients of childbearing potential may participate if adequate contraception is used during the study. (For the purposes of this trial, women of childbearing potential are defined as “All female subjects after puberty unless they are post-menopausal for at least 2 years or are surgically sterile.”). Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients or to Escherichia coli-derived proteins). Presence of neutropenia < 1,5.109/L). Renal failure as defined by estimated glomerular filtration rate (eGFR) <30 ml/min, according to Cockcroft-Gault. Any comorbidity limiting survival or conditions predicting inability to complete the study. History of malignancy in the previous 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy. Any other previous biological treatment administered within 5 -half lives of the specific drug. Any concomitant immune-suppressive medications other than those included in the study protocol. Therapy with prednisone >10 mg daily and/or immuno-suppressive agents within 3 months before the enrolment. Hepatic impairment = Child-Pugh Class C. Mechanical ventilation circulatory assistance. Congenital and/or acquired valvular disease or any other heart disease that could justify the severity of cardiac dysfunction. Major surgery within 2 weeks prior to randomization, or unhealed operation wounds.
    Patologia coronarica attiva (stenosi coronarica >50% in coronarografia o TC coronarica, eseguite nei precedenti 12 mesi). Evidenza di genoma di virus cardiotropi su EBM [Enterovirus, Rhinovirus, Cytomegalovirus, Influenza virus A e B, Adenovirus, Epstein Barr Virus, Parvovirus B19, Human Herpes Virus 6 (HHV6), Varicella Zoster VIRUS (ZVZ)]. Patologie sottostanti potenzialmente responsabili della miocardite, quali: malattia di Lyme, tripanosomiasi, miocardite a cellule giganti. Presenza di infezioni croniche sottostanti, quali: tubercolosi, HIV, HBV o HCV. Gravidanza, allattamento (le donne in età fertile possono partecipare utilizzando metodi contraccettivi efficaci durante tutto lo studio). Controindicazioni ad ANAKINRA (nota ipersensibilità al farmaco o agli eccipienti o a proteine derivate da Escherichia coli. Neutropenia severa (neutrofili <1,5.109/L). Insufficienza renale terminale (Creatine Clearance (CrCl) < 30 ml/min calcolata con la Cockcroft-Gault]. Qualsiasi comorbidità che condizioni una ridotta sopravvivenza o condizione che predica un’inabilità a terminare lo studio. Storia di neoplasia nei 5 anni precedenti, eccetto basalioma cutaneo, carcinoma in situ della cervice e neoplasia prostatica a basso grado dopo intervento curativo. Terapia con farmaci biologici precedente (entro 5 –emivite dello specifico farmaco). Qualsiasi altro trattamento immunosoppressivo in atto differente da quello incluso nello studio. Terapia con prednisone >10 mg die e/o terapia immunosoppressiva nei 3 mesi precedenti. Insufficienza epatica terminale = Child-Pugh Class C. Ventilazione meccanica e supporto meccanico del circolo. Patologie cardiache valvolari e/o congenite che possano giustificare la disfunzione cardiaca. Interventi di chirurgia maggiore nelle 2 settimane precedenti la randomizzazione, o presenza di ferite chirurgiche non cicatrizzate.
    E.5 End points
    E.5.1Primary end point(s)
    2-months improvement in left-ventricular function, based on the increase of left ventricular (LV) ejection fraction (EF) assessed by transthoracic echocardiography.
    Valutazione dell’efficacia di ANAKINRA aggiunto allo standard of care su funzione ventricolare sinistra (LVEF) valutata mediante ecocardiografia transtoracica (TTE) a 2 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    Due mesi
    E.5.2Secondary end point(s)
    Arrhytmic burden (number of ventricular and supraventricular ectopic beats, runs of sutained or non-sustained ventricular tachycardia) at 3 different time points: 2 weeks, 2 months and 6 months.; LVEF assessed by TTE at 2 weeks and at 6 months; LV volumes and diameters on TTE at 3 different time points: 2 weeks, 2 months and 6 months.; Heart failure symptoms [NYHA class], PROs (Minnesota Living with SF36, Heart Failure and Kansas City Cardiomiopathy questionnaires), QALYs and 6-minute walking test at 3 different time points: 2 weeks, 2 months and 6 months.; Inflammatory markers (CRP, ESR, IL1RA, IL1¿, IL1¿, IL6 and IL18) serum levels at 3 different time points: 2 weeks, 2 months and 6 months.; Number of days alive free of any myocarditis complications defined as ventricular arrhythmias, heart failure, chest pain, syncope, at 3 different time points: 2 weeks, 2 months and 6 months.; Reduction in all cause of death, cardiovascular death and heart failure rate at 3 different time points: 2 weeks, 2 months and 6 months.; 2 settimane, 2 mesi e 6 mesi; Cardiac biomarkers (NT-proBNP and high sensitive troponin T) serum levels at 2 weeks, 2 months and 6 months.
    Burden aritmico (numero di extrasistoli ventricolari e sopraventricolari e runs di tachicardia ventricolare non sostenuta) valutato con ECG-Holter 24h a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; LVEF valutata mediante TTE a 2 settimane e 6 mesi.; Volumi e diametri ventricolari al TTE a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; Sintomi da scompenso cardiaco (classe NYHA) e qualità di vita dei pazienti misurata con diversi Patients Reported Outcomes (Minnesota Living with SF36, Heart Failure and Kansas City Cardiomiopathy questionnaires), QALYs e 6-minute walking test a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; Livelli sierici degli indici di flogosi sistemica (VES e PCR) e delle citochine pro-infiammatorie (IL1RA, IL1¿, IL1¿, IL6 e IL18) a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; Numero di giorni liberi da ogni complicanza della miocardite, definita da aritmie ventricolari, scompenso cardiaco, sincope, dolore toracico e disfunzione ventricolare a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; Riduzione di tutte le cause di morte, morti cardiovascolari e scompenso cardiaco a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; Numero di eventi avversi farmaco-relati che richiedono sospensione farmagologica a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.; Livelli sierici dei biomarcatori di danno cardiaco (NT-proBNP e troponina) a 3 differenti time points: 2 settimane, 2 mesi e 6 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 weeks, 2 months and 6 months; 2 weeks and at 6 months; 2 weeks, 2 months and 6 months; 2 weeks, 2 months and 6 months; 2 weeks, 2 months and 6 months.; 2 weeks, 2 months and 6 months; 2 weeks, 2 months and 6 months; Baseline, 2 weeks, 2 months and 6 months; 2 weeks, 2 months and 6 months
    2 settimane, 2 mesi e 6 mesi; 2 settimane e 6 mesi; 2 settimane, 2 mesi e 6 mesi; 2 settimane, 2 mesi e 6 mesi; 2 settimane, 2 mesi e 6 mesi; 2 settimane, 2 mesi e 6 mesi; 2 settimane, 2 mesi e 6 mesi; Number of major drug-related side effects requiring therapy withdrawal at 4 different time points: baseline, 2 weeks, 2 months and 6 months.; 2 settimane, 2 mesi e 6 mesi
    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 No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days10
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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)
    After the end of the study, all subjects will be followed-up according to good clinical practice and current guidelines.
    Al termine dello studio, tutti i soggetti proseguiranno follow-up come da pratica clinica e in conformità con attuali linee guida.
    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 Decision2019-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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