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    Summary
    EudraCT Number:2020-005643-22
    Sponsor's Protocol Code Number:AG10-304
    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:2021-11-17
    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 number2020-005643-22
    A.3Full title of the trial
    An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)
    Studio di estensione in aperto e monitoraggio della sicurezza di acoramidis (AG10) in partecipanti con cardiomiopatia amiloide da transtiretina sintomatica che hanno completato la sperimentazione di fase 3 ATTRibute-CM (AG10-301)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study and safety monitoring of Acoramidis (AG10) in participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
    Studio di estensione e monitoraggio della sicurezza di Acoramidis (AG10) in partecipanti con cardiomiopatia amiloide da transtiretina (ATTR-CM)
    A.3.2Name or abbreviated title of the trial where available
    Safety monitoring of Acoramidis (AG10) in Subjects with Transthyretin Amyloid Cardiomyopathy
    Monitoraggio di sicurezza di Acoramidis (AG10) in soggetti con cardiomiopatia amiloide da transtiret
    A.4.1Sponsor's protocol code numberAG10-304
    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 SponsorEidos Therapeutics, Inc
    B.1.3.4CountryUnited States
    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 supportEidos Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEidos Therapeutics, Inc.
    B.5.2Functional name of contact pointSr. Director, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1800 Owens Street, Suite C-1200
    B.5.3.2Town/ citySan Francisco, CA
    B.5.3.3Post code94158
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014158871482
    B.5.5Fax number000000
    B.5.6E-mailvknobel@eidostx.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2081 - EMA/OD/096/18
    D.3 Description of the IMP
    D.3.1Product nameAcoramidis (AG10)
    D.3.2Product code [AG10 HCL]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAcoramidis
    D.3.9.1CAS number 2242751-53-5
    D.3.9.2Current sponsor coden/a
    D.3.9.4EV Substance CodeSUB193376
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
    Cardiomiopatia amiloide da transtiretina sintomatica (ATTR-CMl)
    E.1.1.1Medical condition in easily understood language
    Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a rare disease that occurs when a protein, called transthyretin, is accumulated in the heart.
    Cardiomiopatia amiloide transthyretin sintomatica (ATTR-CM) è una malattia rara che si verifica quando una proteina, chiamata transtiretina, si accumula nel cuore.
    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 10002020
    E.1.2Term Amyloid cardiomyopathy
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety and tolerability of acoramidis in participants with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM)
    • Valutare la sicurezza e la tollerabilità di acoramidis in partecipanti affetti/e da cardiomiopatia amiloide da transtiretina (ATTR-CM) sintomatica
    E.2.2Secondary objectives of the trial
    To evaluate the effect of acoramidis on: all-cause mortality and cardiovascular (CV) mortality; the 6-minute walk test (6MWT); health-related quality of life (QoL) Kansas City Cardiomyopathy Questionnaire (KCCQ); the frequency of CV-related hospitalization
    Valutare l’effetto di acoramidis su:mortalità per qualsiasi causa e sulla mortalità cardiovascolare (CV); test del cammino di 6 minuti (6MWT); qualità della vita correlata alla salute (QoL) secondo il Questionario di Kansas City per la cardiomiopatia (KCCQ); frequenza dei ricoveri correlati a cause CV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this OLE study, participants must meet all the following criteria:
    1. Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures.
    2. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
    3. Female participants of childbearing potential who engage in heterosexual intercourse must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis. Female participants using oral contraceptives must agree to use an additional birth control method. While not considered highly effective, a double-barrier method is acceptable. A male participant who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control.
    Per essere ritenuti/e idonei/e a partecipare a questo studio OLE, i/le partecipanti devono soddisfare tutti i criteri elencati di seguito:
    1. aver completato 30 mesi di trattamento dello studio in cieco dello Studio AG10-301 e la visita del Mese 30 dello Studio AG10-301, comprese le valutazioni e le procedure;
    2. essere in grado di comprendere e firmare un modulo di consenso informato scritto, che deve essere ottenuto prima dell’inizio delle valutazioni e delle procedure dello studio.
    3. Le partecipanti di sesso femminile in età fertile che hanno rapporti eterosessuali devono accettare di utilizzare un metodo contraccettivo altamente efficace a partire dal momento dell'arruolamento e fino a 30 giorni dopo la somministrazione dell’ultima dose di acoramidis. Le partecipanti di sesso femminile che utilizzano contraccettivi orali devono accettare di usare un ulteriore metodo contraccettivo. Sebbene non sia considerato altamente efficace, l'utilizzo di un metodo contraccettivo a doppia barriera è accettato. Un partecipante di sesso maschile, sessualmente attivo con una donna in età fertile e non sottoposto a vasectomia, deve accettare di utilizzare un metodo contraccettivo a doppia barriera.
    E.4Principal exclusion criteria
    Participants who meet any of the following criteria at the Day 1 visit will not be eligible to participate in the study:
    1. Acute myocardial infarction, acute coronary syndrome or coronary revascularization within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days prior to Day 1.
    2. Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
    3. Has had a heart and/or liver transplant or is on the heart transplantation list within the year prior to Day 1
    4. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for implantation of a CMAD
    5. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
    6. Has estimated glomerular filtration rate (eGFR) by modification of diet for renal disease (MDRD) formula < 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any subsequent central lab value prior to Day 1.
    7. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.
    8. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the study), participant is on prohibited medication.
    9. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day 1 visit and at each study visit are required for female participants of childbearing potential.
    10. In the judgment of the Investigator or Medical Monitor, has any clinically important ongoing medical condition or laboratory abnormality or condition that might jeopardize the participant's safety, increase their risk from participation, or interfere with the study.
    11. Participation in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing. Participation in observational and/or registry studies should be discussed with the Medical Monitor.
    12. Has any condition that in the opinion of the Investigator or Medical Monitor would preclude compliance with the study protocol such as a history of substance abuse, alcoholism, or a psychiatric condition.
    I/le partecipanti che soddisfano uno qualsiasi dei seguenti criteri alla visita del Giorno 1 non saranno ritenuti/e idonei/e a partecipare allo studio:
    1. infarto miocardico acuto, sindrome coronarica acuta o rivascolarizzazione coronarica nei 90 giorni prima del Giorno 1, ictus o attacco ischemico transitorio (AIT) nei 90 giorni precedenti il Giorno 1;
    2. instabilità emodinamica che, a giudizio dello sperimentatore, comporterebbe un rischio eccessivo in caso di partecipazione allo studio;
    3. aver subito un trapianto di cuore e/o di fegato o essere in lista d'attesa per ricevere un trapianto di cuore nell’anno precedente il Giorno 1;
    4. aver subito o prevedere l'impianto di un dispositivo di assistenza meccanica cardiaca;
    5. aver ricevuto una diagnosi confermata di amiloidosi da catene leggere (AL) in qualsiasi momento durante lo studio AG10-301;
    6. presentare una velocità di filtrazione glomerulare stimata (eGFR) mediante la formula della modifica della dieta nella malattia renale (MDRD) < 15 ml/min/1,73 m2 al Mese 27 dello studio AG10-301 o pari a qualsiasi valore successivo fornito dal laboratorio centrale prima del Giorno 1;
    7. nota ipersensibilità a acoramidis, ai suoi metaboliti o agli eccipienti della formulazione;
    8. al termine dello studio AG10-301 o al Giorno 1 dello studio AG10-304 (o in qualsiasi momento durante lo studio), il/la partecipante sta assumendo un farmaco proibito;
    9. partecipanti di sesso femminile in gravidanza o in fase di allattamento; per le partecipanti di sesso femminile in età fertile è richiesto un test di gravidanza sulle urine con esito negativo alla visita del Giorno 1 e a ogni visita dello studio;
    10. a giudizio dello sperimentatore o del responsabile del monitoraggio medico, presentare qualsiasi patologia medica in corso o anomalia di laboratorio o patologia di rilevanza clinica che possa mettere a rischio la sicurezza del/la partecipante, aumentare il rischio associato alla partecipazione o interferire con lo studio;
    11. partecipazione a un’altra sperimentazione clinica interventistica (ad eccezione dello studio AG10-301) nei 30 giorni precedenti la somministrazione. La partecipazione a studi osservazionali e/o di registro deve essere discussa con il responsabile del monitoraggio medico;
    12. presentare qualsiasi patologia che, a giudizio dello sperimentatore o del responsabile del monitoraggio medico, potrebbe impedire la conformità al protocollo dello studio, come un’anamnesi di abuso di sostanze, alcolismo o condizione psichiatrica.
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters to be assessed: treatment- emergent serious adverse events (SAEs) and adverse events (AEs), AEs leading to treatment discontinuation, abnormal physical exam findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal electrocardiogram (ECG) parameters of clinical relevance, and changes in clinical safety laboratory parameters of clinical relevance
    Parametri di sicurezza da valutare: eventi avversi gravi (SAE) ed eventi avversi (EA) emergenti dal trattamento, EA responsabili dell'interruzione del trattamento, risultati anomali dell’esame obiettivo di rilevanza clinica, parametri vitali anomali di rilevanza clinica, parametri di elettrocardiogramma (ECG) anomali di rilevanza clinica e variazioni nei parametri di laboratorio di sicurezza clinica di rilevanza clinica
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs: Month 0-60; ET, unscheduled visit
    Physical examination, Vital signs, ECG: Day 1, Month 1, Month 6-60 every 6 months, Month 61; ET, unscheduled visit, 30 days post last dose
    EA: mese 0-60; ET, visita non programmate
    Esame obiettivo, Segni vitali, ECG: Giorno 1, Mese 1, Mese 6-60 ogni 6 mesi, Mese 61; ET, visita non programmata, 30 giorni dopo l'ultima dose
    E.5.2Secondary end point(s)
    - All-cause mortality and CV mortality
    - Change from Baseline in distance walked during the 6MWT
    - Change from Baseline in KCCQ Overall Score (KCCQ-OS)
    - CV-related hospitalization
    - Mortalità per tutte le cause e mortalità CV
    - Variazione dalla linea di base della distanza percorsa durante il 6MWT
    - Variazione dal basale nel punteggio complessivo KCCQ (KCCQ-OS)
    - Ricovero per CV
    E.5.2.1Timepoint(s) of evaluation of this end point
    - All-cause mortality and CV mortality: Month 0-61
    - Distance walked during the 6MWT: Day 1, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60; ET, unscheduled visit
    - KCCQ will be obtained on Day 1, Month 1, Month 6, and every 6 months up to Month 60 during the study. KCCQ should be completed prior to the EQ-5D-5L and prior to conduction of the 6MWT at those visits during which a 6MWT is performed
    - CV-related hospitalization will be summarized by number of patients who have at least one CV-related hospitalization and the frequency of CV-related hospitalization; cumulative frequency of CV-related hospitalization: Month 0-61
    - Mortalità per tutte le cause e mortalità CV: Mesi 0-61
    - Distanza percorsa durante il 6MWT: Giorno 1, Mese 6, 12, 18, 24, 30, 36, 42, 48, 54, 60; ET, visita non programmata
    - Il KCCQ sarà ottenuto il giorno 1, il mese 1, il mese 6 e ogni 6 mesi fino al mese 60 durante lo studio. Il KCCQ deve essere completato prima dell'EQ-5D-5L e prima della conduzione del 6MWT in quelle visite durante le quali viene eseguito un 6MWT
    - Il ricovero per CV sarà riassunto dal numero di pazienti che hanno avuto almeno un ricovero per CV e la frequenza di ricovero per CV; frequenza cumulativa di ospedalizzazione correlata al CV: Mese 0-61
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Israel
    Korea, Republic of
    New Zealand
    United States
    Belgium
    Denmark
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    United Kingdom
    Czechia
    Greece
    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 years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 535
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 223
    F.4.2.2In the whole clinical trial 546
    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)
    The study is planned to continue until participants have access to acoramidis by prescription for treatment of ATTR-CM or up to approximately 60 months treatment period, followed by 1-month follow-up. Total duration of participation in the study is expected to be up to approximately 61 months.
    Si prevede che lo studio continui fino a quando i partecipanti non avranno accesso ad acoramidis tramite prescrizione per il trattamento di ATTR-CM o fino a un periodo di trattamento di circa 60 mesi, seguito da un mese di follow-up. La durata totale della partecipazione allo studio dovrebbe essere fino a circa 61 mesi.
    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 Decision2022-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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