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    Summary
    EudraCT Number:2021-001924-16
    Sponsor's Protocol Code Number:FDY-5301-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-26
    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 number2021-001924-16
    A.3Full title of the trial
    IOCYTE AMI-3: A Multicenter Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction
    IOCYTE AMI-3: Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato con placebo, di FDY-5301 somministrato per via endovenosa in pazienti affetti da infarto miocardico in sede anteriore con sopraslivellamento del tratto ST
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of IV FDY-5301 in patients with a myocardial infarction (STEMI)
    Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato con placebo, di FDY-5301 somministrato per via endovenosa in pazienti affetti da infarto miocardico (STEMI)
    A.3.2Name or abbreviated title of the trial where available
    IOCYTE AMI-3
    IOCYTE AMI-3
    A.4.1Sponsor's protocol code numberFDY-5301-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04837001
    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 SponsorFaraday Pharmaceuticals, 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 supportFaraday Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Inc.
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street Address5400 Medpace Way
    B.5.3.2Town/ cityCincinnati
    B.5.3.3Post codeOH 45227
    B.5.3.4CountryUnited States
    B.5.6E-mailregsubmissions@medpace.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 nameFDY-5301
    D.3.2Product code [FDY-5301]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Iodide
    D.3.9.1CAS number 7681-82-5
    D.3.9.2Current sponsor codeFDY-5301
    D.3.9.3Other descriptive nameSODIUM IODIDE
    D.3.9.4EV Substance CodeSUB15295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anterior ST-Elevation Myocardial Infarction
    Infarto miocardico in sede anteriore con sopraslivellamento del tratto ST
    E.1.1.1Medical condition in easily understood language
    Myocardial Infarct (heart attack)
    Infarto del miocardio (attacco cardiaco)
    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 SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    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 assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI.
    Valutare l’effetto di FDY-5301 sulla mortalità cardiovascolare e sugli eventi di insufficienza cardiaca in soggetti con STEMI anteriore sottoposti a pPCI.
    E.2.2Secondary objectives of the trial
    To assess the effect of FDY-5301 on other clinical outcomes such as all-cause mortality and cardiovascular outcomes in subjects with an anterior STEMI undergoing pPCI
    Valutare l’effetto di FDY-5301 su altri esiti clinici come mortalità per qualsiasi causa ed esiti cardiovascolari in soggetti con STEMI anteriore sottoposti a pPCI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >= 18 years
    2. Anterior STEMI, based on:
    Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and
    ECG criteria:
    • men > 40 years: >= 2 mm of ST elevation in V2 and V3
    • men <= 40 years: >= 2.5 mm of ST elevation in V2 and V3
    • women: >= 1.5 mm of ST elevation in V2 and V3
    3. Planned primary PCI to occur <= 6 hours of onset of first symptoms of myocardial ischemia
    4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent obtained for study participation
    1. Età >=18 anni
    2. STEMI anteriore, in base a:
    Sintomi di ischemia miocardica (quali dolore toracico, respiro affannoso, dolore mandibolare, dolore al braccio, diaforesi o qualsiasi sintomo anginoso equivalente) e
    Criteri relativi all’elettrocardiogramma (ECG):
    • Uomini di età >40 anni: >=2 mm di sopraslivellamento del tratto ST in V2 e V3;
    • Uomini di età <=40 anni: >=2,5 mm di sopraslivellamento del tratto ST in V2 e V3;
    • Donne: >=1,5 mm di sopraslivellamento del tratto ST in V2 e V3.
    3. PCI primario la cui esecuzione è programmata =<6 ore dall’insorgenza dei primi sintomi di ischemia miocardica
    4. Acquisizione del consenso alla partecipazione allo studio approvato dal Comitato etico indipendente (CEI)
    E.4Principal exclusion criteria
    1. Life expectancy of less than 1 year due to non-cardiac pathology
    2. Known thyroid disease or thyroid disorder, including subjects on
    thyroid hormone replacement therapy at the time of randomization
    3. Known allergy to iodine
    4. Renal disease requiring dialysis
    5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
    6. Body weight >140 kg
    7. Use of thrombolytic therapy as treatment for the index STEMI event
    8. Use of investigational drugs or devices 30 days prior to randomization
    9. Any clinically significant abnormality identified prior to randomization
    that in the judgment of the Investigator or Sponsor would preclude safe
    completion of the study, or confound the anticipated benefit of FDY-5301
    1. Aspettativa di vita inferiore a 1 anno a causa di una patologia non cardiaca

    2. Malattia o disturbo tiroidea/o nota/o, inclusi i soggetti sottoposti a una terapia sostitutiva con ormoni tiroidei al momento della randomizzazione

    3. Allergia nota allo iodio

    4. Malattia renale che richiede il ricorso alla dialisi

    5. Soggetti di sesso femminile in gravidanza o che stanno allattando al seno. Le donne in età fertile devono risultare negative al test di gravidanza prima della randomizzazione

    6. Peso corporeo >140 kg

    7. Uso di una terapia trombolitica come trattamento per l’evento STEMI indice

    8. Uso di farmaci o dispositivi sperimentali nei 30 giorni che precedono la randomizzazione

    9. Qualsiasi anomalia clinicamente significativa identificata prima della randomizzazione che, a giudizio dello sperimentatore o dello Sponsor, precluderebbe il completamento sicuro dello studio o confonderebbe il beneficio previsto di FDY-5301
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who experience either cardiovascular
    mortality (defined as deaths which are sudden and due to presumed
    arrhythmia, or deaths due to presumed or confirmed thromboembolic
    CVA, presumed or confirmed pulmonary embolism, cardiac rupture, heart
    failure, recurrent myocardial infarction [e.g., remote or stent
    thrombosis], and deaths due to procedural efforts to treat these defined
    cardiac events), or a heart failure event through Month 12
    Percentuale di soggetti che manifestano mortalità cardiovascolare (definita come decesso improvviso dovuto a presunta aritmia o decesso dovuto ad accidente tromboembolico cerebrovascolare presunto o confermato, embolia polmonare presunta o confermata, rottura cardiaca, insufficienza cardiaca, infarto miocardico ricorrente [ad es. trombosi remota o da stent] e decesso dovuto a tentativi procedurali di trattare questi eventi cardiaci definiti) o un evento di insufficienza cardiaca fino al Mese 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    through month 12
    fino al mese 12
    E.5.2Secondary end point(s)
    •The proportion of subjects who experience either all-cause mortality or
    a heart failure event through Month 12
    •The total number of cardiovascular events defined as cardiovascular
    mortality and heart failure events through Month 12
    •The proportion of subjects who experience specified non-fatal
    cardiovascular events of thromboembolic cerebral vascular accident
    (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial
    infarction (e.g., remote or stent thrombosis), or persistent arrhythmia
    through Month 12
    •Serum troponin T at Day 3
    • Percentuale di soggetti che manifestano mortalità per qualsiasi causa o un evento di insufficienza cardiaca fino al Mese 12
    • Numero totale di eventi cardiovascolari definiti come mortalità cardiovascolare ed eventi di insufficienza cardiaca fino al Mese 12
    • Percentuale di soggetti che manifestano eventi cardiovascolari non fatali specificati di accidente cerebrovascolare (ACV) tromboembolico,
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2 for evaluation timing
    vedere la sezione E.5.2 per il tempo di rilevazione
    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 Yes
    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 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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Canada
    Israel
    United States
    Poland
    Netherlands
    Spain
    Czechia
    Germany
    Italy
    Hungary
    Portugal
    Slovakia
    United Kingdom
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1800
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-08-26. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In case subject is not able to give consent - emergency situation
    (STEMI) and if allowed by regulations LAR can sign the informed
    consent form on behalf of the subject. The subject will sign the full
    consent form as soon as the condition has improved
    Nel caso in cui il soggetto non sia in grado di dare il consenso - situazione di emergenza
    (STEMI) e se consentito dalla normativa LAR può firmare l'informato
    modulo di consenso per conto del soggetto. Il soggetto firmerà per intero
    modulo di consens
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1600
    F.4.2.2In the whole clinical trial 2300
    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)
    none
    nessuno
    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 Decision2022-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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