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    Summary
    EudraCT Number:2017-002333-40
    Sponsor's Protocol Code Number:ARGX-113-1701
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-29
    Trial results View 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 number2017-002333-40
    A.3Full title of the trial
    An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus)
    Studio in aperto, non controllato, di fase II per valutare la sicurezza, la farmacodinamica, la farmacocinetica, l’efficacia e le condizioni d’utilizzo di ARGX 113 in pazienti affetti da pemfigo (volgare o foliaceo) da lieve a moderato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus)
    Studio per valutare la sicurezza e l'efficacia di ARGX-113 in pazienti affetti da pemfigo (volgare o foliaceo) da lieve a moderato
    A.3.2Name or abbreviated title of the trial where available
    A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus
    Studio per valutare la sicurezza e l'efficacia di ARGX-113 in pazienti affetti da pemfigo (volgare o
    A.4.1Sponsor's protocol code numberARGX-113-1701
    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 SponsorARGEN-X BVBA
    B.1.3.4CountryBelgium
    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 supportargenx BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BVBA
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032093103400
    B.5.5Fax number0032093103499
    B.5.6E-mailregulatory@argenx.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 nameARGX-113
    D.3.2Product code [ARGX-113]
    D.3.4Pharmaceutical form Solution for infusion
    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 INNefgartigimod
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.4EV Substance CodeSUB180001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pemphigus (Vulgaris or Foliaceus)
    Pemfigo (volgare o foliaceo)
    E.1.1.1Medical condition in easily understood language
    Pemphigus (Vulgaris or Foliaceus)
    Pemfigo (volgare o foliaceo)
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052802
    E.1.2Term Pemphigus vulgaris
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057069
    E.1.2Term Pemphigus foliaceus
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of ARGX-113 in PV and PF patients.
    Valutare la sicurezza e tollerabilità di ARGX 113 in pazienti affetti da pemfigo volgare (PV) e pemfigo foliaceo (PF).
    E.2.2Secondary objectives of the trial
    - To define the therapeutic dose and the dose regimen through the pharmacodynamic (PD) and clinical efficacy findings;
    - To evaluate the serum levels of immunoglobulin (Ig) G (total IgG and subtypes) following ARGX-113 treatment;
    - To evaluate the serum levels of anti-desmoglein (Dsg)-1 and -3 autoantibodies following ARGX-113 treatment;
    - To assess the efficacy on cutaneous and mucosal pemphigus lesions;
    - To measure the pharmacokinetics (PK) of ARGX-113;
    - To investigate the immunogenicity of ARGX-113.
    - Definire la dose terapeutica e il regime posologico mediante i risultati di farmacodinamica (PD) ed efficacia clinica;
    - Valutare i livelli sierici dell’immunoglobulina (Ig) G (IgG totale e sottotipi) a seguito del trattamento con ARGX 113;
    - Valutare i livelli sierici degli autoanticorpi anti desmogleina (Dsg) 1 e 3 a seguito del trattamento con ARGX 113;
    - Valutare l’efficacia sulle lesioni da pemfigo cutanee e mucosali;
    - Valutare la farmacocinetica (PK) di ARGX 113;
    - Investigare l’immunogenicità di ARGX 113.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged =18 years.
    2. Clinical diagnosis of PV or PF, that has been confirmed by positive direct immunofluorescence and positive indirect immunofluorescence and/or enzyme-linked immunosorbent assay (ELISA
    3. Mild to moderate disease severity (Pemphigus Disease Area Index [PDAI] < 45).
    4.Newly diagnosed patients or relapsing patients off therapy; or patients who relapse despite oral prednisone at tapered dose +/- a conventional immunosuppressant (e.g. azathioprine, mycophenolate mofetil).
    5. Identified serum levels of autoantibodies directed against Dsg-3 and/or Dsg-1 antigen at screening, using indirect immunofluorescence or ELISA.
    6. Ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).
    1. Pazienti di entrambi i sessi di età = 18 anni.
    2. Diagnosi clinica di PV o PF, confermata dall’immunofluorescenza positiva diretta e dall’immunofluorescenza positiva indiretta e/o dal saggio di immunoassorbimento enzimatico (ELISA).
    3. Severità della malattia da lieve a moderata (punteggio < 45 della scala PDAI [Pemphigus Disease Area Index]).
    4. Pazienti con nuova diagnosi o pazienti recidivanti non in terapia; o pazienti che hanno recidivato nonostante la somministrazione di prednisone orale alla dose scalata +/- un immunosoppressore convenzionale (ad es., azatioprina, micofenolato mofetile).
    5. Livelli sierici identificati di autoanticorpi diretti contro gli antigeni di Dsg-3 e/o Dsg-1 allo screening, mediante immunofluorescenza indiretta o ELISA.
    6. Capacità di comprendere i requisiti dello studio, accordare il consenso informato scritto (compreso il consenso all’uso e alla divulgazione dei dati sanitari correlati alla ricerca) e di aderire alle procedure previste dal protocollo dello studio (comprese le necessarie visite dello studio).
    E.4Principal exclusion criteria
    1. Pregnant and lactating women, and those intending to become pregnant during the study or within 90 days after the last dosing.Women
    of childbearing potential should have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline, prior to administration of IMP.
    2. Male patients who are sexually active that do not intend to use effective methods of contraception during the study or within 90 days after the last dosing.
    3. Confirmed diagnosis of pemphigus foliaceus, paraneoplastic pemphigus, drug-induced pemphigus or any other non-PV/non-PF autoimmune blistering disease.
    4. History of refractory disease to active third line therapy (e.g. intravenous polyvalent human immunoglobulins [IVIg], rituximab, plasma exchange/ immunoadsorption).
    5. Use of therapies other than oral prednisone and conventional immunosuppressants, that can interfere in the clinical course of the disease (e.g. intravenous [IV] prednisolone bolus, dapsone,
    sulfasalazine, tetracyclines, nicotinamide, plasmapheresis/ plasma exchange, immunoadsorption and IVIg) within 2 months prior to Baseline visit.
    6. Use of rituximab and other CD20 target biologics within 6 months prior to Baseline visit.
    7. History of anaphylactic reaction, or a known hypersensitivity reaction to one of the components of the IMP.
    8. History of vaccination within the last 4 weeks prior to Baseline visit, or with a planned vaccination during the study, with the exception of
    seasonal vaccination (e.g. influenza vaccine).
    9. Recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to Baseline visit.
    10. Known active or chronic viral infection with hepatitis B virus (HBV); refer to the Centers for Disease Control and Prevention (CDC) guidelines.
    11. Known seropositive or active infection with hepatitis C virus (HCV).
    12. Known history of known infection with viral infection with human immunodeficiency virus (HIV 1 and 2 antibodies).
    13. Body Mass Index (BMI) at Screening > 35,0 kg/m2.
    14. Clinical evidence of significant active, unstable or uncontrolled concomitant disease (e.g. cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinological and metabolic, hepatic, renal, neurologic, malignancy, infectious diseases, coagulopathies, other autoimmune disease) or condition (lack of peripheral venous access, recent major surgery, etc), which, in the opinion of the investigator, puts the patient at undue risk or may affect the interpretation of the results.
    15. Patients in general health condition not allowing study participation (Karnofsky index < 60%; see Appendix 14.2).
    16. At Screening, have clinically significant laboratory abnormalities as below:
    a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN)
    b. Total serum bilirubin of > 1.5 x ULN (except for Grade 1 hyperbilirubinemia as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), due solely to a documented medical diagnosis of Gilbert’s syndrome)
    c. Serum creatinine of > 1.5 mg/dL or creatinine clearance < 50 mL/min (using the Chronic Kidney Disease Epidemiology -Creatinine formula)
    d. Hemoglobin (Hb) = 9 g/dL
    e. International normalized ratio (INR) > 1.5 or activated partial thromboplastin time (aPTT) > 1.5 x ULN
    f. Total immunoglobulin G (IgG) level < 6 g/L
    g. Presence of > 1 + proteinuria dipstick
    17. Patient having participated in another interventional study within the last 3 months prior to Baseline visit.
    1. Donne in gravidanza o che allattano e quelle che prevedono di iniziare una gravidanza durante lo studio o entro 90 giorni dalla somministrazione dell’ultima dose. Le donne fertili devono avere un test di gravidanza sierico negativo allo Screening e un test di gravidanza sulle urine negativo al Baseline, prima della somministrazione dell'IMP.
    2. Pazienti di sesso maschile sessualmente attivi, che non intendono far uso di metodi contraccettivi efficaci durante lo svolgimento dello studio o nei 90 giorni successivi alla somministrazione dell’ultima dose.
    3. Diagnosi confermata di pemfigo foliaceo, pemfigo paraneoplastico, pemfigo farmaco-indotto o qualsiasi altra malattia bollosa autoimmune diversa dal PV o dal PF.
    4. Anamnesi di malattia refrattaria alla terapia di terza linea (ad es., immunoglobuline umane polivalenti per via endovenosa [IVIg], rituximab, scambio del plasma/immunoassorbimento).
    5. Uso di terapie diverse dal prednisone orale e immunosoppressori convenzionali, che possono interferire con il decorso clinico della malattia (ad es., bolo di prednisolone endovenoso [e.v.], dapsone, sulfasalazina, tetracicline, nicotinamide, plasmaferesi/scambio del plasma, immunoassorbimento e IVIg) nei 2 mesi precedenti al Baseline.
    6. Uso di rituximab e altri farmaci biologici mirati alla proteina CD20 nei 6 mesi precedenti al Baseline.
    7. Anamnesi di reazione anafilattica o nota reazione di ipersensibilità a uno qualsiasi degli eccipienti dell’IMP.
    8. Anamnesi di vaccinazione nelle ultime 4 settimane precedenti al Baseline o una vaccinazione prevista durante lo studio, con l'eccezione della vaccinazione stagionale (es. vaccino influenzale).
    9. Grave infezione recente (ovvero necessitante di terapia antimicrobica iniettabile o ricovero in ospedale) nelle 8 settimane precedente al Baseline.
    10. Nota infezione virale attiva o cronica da virus dell’epatite B (HBV); consultare le linee guida dei Centers for Disease Control and Prevention (CDC).
    11. Nota sieropositività o infezione attiva da virus dell’epatite C (HCV).
    12. Nota anamnesi di nota infezione virale da virus dell’immunodeficienza umana (anticorpi anti HIV 1 e 2).
    13. Indice di massa corporea (BMI) > 35,0 kg/m2 allo screening.
    14. Evidenza clinica di importante patologia concomitante attiva, instabile o non controllata (ad es., patologia cardiovascolare, polmonare, ematologica, gastrointestinale, endocrina e metabolica, epatica, renale, neurologica, neoplastica maligna, infettiva, coagulopatie, altra patologia autoimmune) oppure condizione patologica (assenza di accesso venoso periferico, recente intervento chirurgico maggiore, ecc.) che, a giudizio dello sperimentatore, esponga il paziente a rischio inutile o influenzi l’interpretazione dei risultati.
    15. Pazienti il cui stato di salute generale non li rende idonei alla partecipazione (indice Karnofsky < 60%; vedere Allegato 14.2).
    16. Pazienti che presentano allo screening i seguenti risultati anomali di laboratorio clinicamente significativi:
    a. aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) > 3 volte il limite superiore della norma (ULN).
    b. bilirubina sierica totale > 1,5 x ULN (eccetto per l’iperbilirubinemia di grado 1 secondo i criteri NCI CTCAE [National Cancer Institute Common Terminology Criteria for Adverse Events], causata esclusivamente dalla diagnosi medica documentata di sindrome di Gilbert)
    c. creatinina sierica > 1,5 mg/dL o clearance della creatinina < 50 mL/min (utilizzando la formula per la creatinina proposta dal Chronic Kidney Disease Epidemiology)
    d. emoglobina (Hb) = 9 g/dL
    e. rapporto internazionale normalizzato (INR) > 1,5 o tempo di tromboplastina parziale attivata (aPTT) > 1,5 x ULN
    f. livello di immunoglobulina G (IgG) totale < 6 g/L
    g. presenza di proteinuria > 1+ determinata con dipstick
    17. Paziente che ha partecipato ad altro studio interventistico negli ultimi 3 mesi prima del Baseline.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) over the study.
    - Vital signs, electrocardiogram (ECG) parameters, physical examination abnormalities and clinical laboratory assessments.
    - Incidenza e severità degli eventi avversi emergenti dal trattamento (TEAE) e degli eventi avversi seri (SAE) durante lo studio.
    - Anomalie dei parametri vitali, parametri dell’elettrocardiogramma (ECG), dell’esame obiettivo e valutazioni cliniche di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be monitored continuously from signing of informed consent until the last study-related activity
    - Vital signs, physical examination abnormalities and clinical laboratory assessments: screening, V1-9
    - ECG: screening, v5, v7-9
    - Incidenza e severità degli eventi avversi emergenti dal trattamento (TEAE) e degli eventi avversi seri (SAE) saranno monitorati costantemente dal momento della firma del consenso informato fino all’ultima attività correlata allo studio.
    - Anomalie dei parametri vitali, dell’esame obiettivo e valutazioni cliniche di laboratorio: screening, visite 1-9
    - ECG: screening, visite 7-9
    E.5.2Secondary end point(s)
    -Total IgG and subtypes, at Baseline then at each visit.
    -Serum levels of anti-Dsg-1 and -3 autoantibodies, at Baseline then at each visit.
    -PDAI, at each visit.
    -Time to disease control (DC), control being defined as the absence of new lesions and established lesions beginning to heal, evaluated from Visit 2 until control is achieved.
    -Time until relapse, relapse being defined as the appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or as the extension of established lesions, evaluated from any visit following DC.
    - In additional cohort 4 and optional cohort 5, time to end of consolidation, defined as the time at which no new lesions have developed for a minimum of 2 weeks, and approximately 80% of lesions have healed.
    - In additional cohort 4 and optional cohort 5, time to complete clinical remission, as defined by the absence of new lesions and established lesions completely healed (except post-inflammatory hyperpigmentation or erythema from resolving lesions).
    -In additional cohort 4 and optional cohort 5, time to complete clinical remission under minimal therapy, as defined as a prednisone dose of 10 mg/day or less for at least 8 weeks.
    -Pharmacokinetic parameters of ARGX-113, at Baseline then at each visit (pre- and post-dose when IMP is administered).
    -Incidence of anti-drug antibodies (ADA) to ARGX-113, at each visit as per schedule of assessments.
    • IgG totali e sottotipi al basale e successivamente ad ogni visita.
    • Livelli sierici degli autoanticorpi anti-Dsg-1 e -3 al basale e successivamente ad ogni visita.
    • PDAI ad ogni visita.
    • Tempo al controllo della malattia (DC); per controllo si intende l’assenza di nuove lesioni e l’inizio della guarigione di quelle esistenti, valutate a partire dalla Visita 2 fino al raggiungimento del controllo.
    • Tempo fino alla recidiva; per recidiva si intende la comparsa di 3 o più nuove lesioni al mese che non guariscono spontaneamente entro 1 settimana o l’estensione delle lesioni esistenti, valutate ad ogni visita successiva al DC.
    • Nella coorte 4 aggiuntiva e nella coorte 5 opzionale, il tempo alla fine del consolidamento, definito come il momento in cui non si sono sviluppate nuove lesioni per un minimo di 2 settimane e circa l’80% delle lesioni è guarito.
    • Nella coorte 4 aggiuntiva e nella coorte 5 opzionale, il tempo alla remissione clinica completa, definita dall’assenza di nuove lesioni e lesioni già completamente guarite (eccetto iperpigmentazione postinfiammatoria o eritema da lesioni in via di guarigione).
    • Nella coorte 4 aggiuntiva e nella coorte 5 opzionale, il tempo alla remissione clinica completa in terapia minima, definito come una dose di prednisone di 10 mg/die o inferiore per almeno 8 settimane.
    • Parametri farmacocinetici di ARGX-113 al basale e successivamente ad ogni visita (prima e dopo la somministrazione della di IMP).
    • Incidenza degli anticorpi antifarmaco (ADA) contro ARGX-113, ad ogni visita secondo il programma delle valutazioni.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - at Baseline then at each visit
    - at Baseline then at each visit
    - at each visit
    - from Visit 2 until control is achieved
    - from any visit following DC
    -time to end of consolidation
    -time to complete clinical remission,, defined as the time at which no new lesions have developed for a minimum of 2 weeks
    -time to complete clinical remission , as defined by the absence of new lesions and established lesions completely healed
    -time to complete clinical remission under minimal therapy, as defined as a prednisone dose of 10 mg/day or less for at least 8 weeks
    - at Baseline then at each visit
    - at each visit as per schedule of assessments
    - al basale e successivamente ad ogni visita
    - al basale e successivamente ad ogni visita
    - ad ogni visita
    - dalla Visita 2 fino al raggiungimento del controllo
    - ad ogni visita successiva al DC
    - tempo fino alla fine del consolidamento
    - tempo al completamento della remissione clinica, definito come il momento in cui nessuna nuova lesione si è sviluppata per un minimo di 2 settimane
    -tempo al completamento della remissione clinica, definito come assenza di nuove lesioni e lesioni accertate completamente guarite
    -tempo al completamento della remissione clinica sotto terapia minima, definita come una dose prednisone di 10 mg/dì o meno per almeno 8 settimane
    - a Baseline quindi ad ogni visita
    - ad ogni visita come da programma di valutazioni
    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 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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Israel
    Ukraine
    Germany
    Hungary
    Italy
    Romania
    E.8.7Trial has a data monitoring committee No
    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 months3
    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 months3
    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: 10
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 22
    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)
    Patients will return to standard of care treatment.
    I pazienti ritorneranno agli standard di cura.
    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 Decision2018-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
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