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    Summary
    EudraCT Number:2019-004647-74
    Sponsor's Protocol Code Number:LPS15834
    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:2021-06-17
    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 number2019-004647-74
    A.3Full title of the trial
    Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma
    Studio randomizzato, in doppio cieco, controllato con placebo per valutare l’effetto di dupilumab sull’infiammazione delle vie aeree attraverso valutazioni della funzionalità polmonare, dell’ostruzione dovuta al muco e di altri parametri di diagnostica per immagini polmonare nei pazienti asmatici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging in patients with moderate-severe asthma
    L'effetto di dupilumab sulla funzione polmonare e sui relativi cambiamenti nei volumi delle vie aeree rilevabili mediante diagnostica per immagini della funzionalità respiratoria in pazienti con asma moderato-grave
    A.3.2Name or abbreviated title of the trial where available
    VESTIGE
    VESTIGE
    A.4.1Sponsor's protocol code numberLPS15834
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1238-4679
    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 SponsorSANOFI-AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE LUIGI BODIO 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 nameDupilumab
    D.3.2Product code [SAR231893]
    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 INNDUPILUMAB
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    ASTHMA
    ASMA
    E.1.1.1Medical condition in easily understood language
    ASTHMA
    ASMA
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging
    Valutare l’effetto di dupilumab sulla funzione polmonare e sui relativi cambiamenti nei volumi delle vie aeree rilevabili mediante imaging respiratorio funzionale
    E.2.2Secondary objectives of the trial
    To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
    To evaluate safety of dupilumab
    Valutare l’effetto di dupilumab alla Settimana 24 su broncodinamica, iperinflazione, resistenza delle vie aeree, spessore delle pareti delle vie aeree, difetti di ventilazione e ostruzione dovuta a muco acquisiti mediante scansioni di tomografia computerizzata ad alta risoluzione (HRCT), esiti riferiti dal paziente, FeNO e spirometria

    Valutare la sicurezza di dupilumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
    -History of >/= 1 exacerbation (s) in the previous year
    -Uncontrolled moderate to severe asthma (ACQ-5 >/= 1.5) at V1 and V2, prior to randomization
    -Pre-bronchodilator FEV1 </= 80% of predicted normal at V1 and V2, prior to randomization
    -Exhibit bronchodilator reversibility (>/= 12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
    -Blood eosinophil >/= 300 cells /µL and FeNO >/= 25 ppb during screening, prior to randomization
    -Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) ± a third controller. The dose regimen should be stable >/= 1 month prior V1 and during screening.
    Da 18 a 70 anni compiuti con diagnosi di asma basata sulla strategia globale per la gestione e la prevenzione dell’asma (GINA) 2019 al momento della firma del consenso informato
    Anamnesi di >/= 1 riacutizzazione(i) nell’anno precedente
    Asma non controllata da moderata a grave (ACQ-5 >/=1,5) alla V1 e V2, prima della randomizzazione.
    I 04. FEV1 pre-broncodilatatore </=80% del normale previsto alla V1 e V2, prima della randomizzazione.
    I 05. Reversibilità broncodilatatoria (>/=12% e 200 ml di miglioramento del FEV1 in seguito a somministrazione di SABA) durante lo screening, prima della randomizzazione.
    I 06. Eosinofili ematici >/=300 cellule/µl e FeNO>/=25 ppb durante lo screening, prima della randomizzazione.
    I 07. Trattamento esistente con dose ICS da media ad alta in combinazione con un secondo farmaco di controllo (ad es. LABA, LTRA) ± un terzo farmaco di controllo. La posologia deve essere stabile >/= 1 mese prima della V1 e durante lo screening.
    E.4Principal exclusion criteria
    -Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization
    -Previous smoker with a smoking history >10 pack-years
    -Known hypersensitivity to dupilumab or any of its excipients
    -Asthma exacerbation during the screening, prior to randomization
    -Current acute bronchospasm or status asthmaticus
    -Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts
    -History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, etc)
    -Active tuberculosis, latent untreated tuberculosis or a history of incompletely treated tuberculosis or non-tuberculous mycobacterial infection unless it is well documented by a specialist that the patient has been adequately treated and the treatment with a biologic agent can be initiated, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would only be performed on a country by country basis according to the routine clinical practice and the local guidelines, if required by regulatory authorities or ethics committees
    -History of or current evidence of clinically significant disease in any non-respiratory system (e.g. cardiovascular, nervous system, gastrointestinal, endocrinological, rheumatological, dermatological), which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study
    -Current evidence of clinically significant oncological disease, which in the opinion of the investigator may interfere with the objectives of the study or put the subject at undue risk
    -Participants with any of the following results at Visit (V) 1:
    -Positive (or indeterminate) hepatitis B surface antigen (HBs Ag) or
    -Positive Hepatitis B IgM core antibody (IgM HBc Ab) or
    -Positive total hepatitis B core antibody (total HBc Ab) confirmed by positive HBV DNA or
    -Positive hepatitis C antibody (HCV Ab) confirmed by positive HCV RNA
    -History of human immunodeficiency virus (HIV) infection or positive HIV serology at V 1
    -Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant within 3 months prior to V1
    -Treatment with live (attenuated) vaccine within 12 weeks before V1
    -Chronic treatment with oral corticosteroids (OCS) for more than 2 weeks before V1
    -Enrolled in other ongoing studies regardless of the investigational product
    -Treatment with an investigational drug within 8 weeks or within 5 halflives (if known), whichever is longer, prior to V1
    -Suspected or high risk of parasitic infection (helminthic infection), unless clinical and (if necessary) laboratory assessments have ruled out active infection prior to randomization
    -Females who are lactating, breastfeeding, or who are pregnant
    -Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized
    -Patients are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH GCP Ordinance E6)
    -Patients are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
    -Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
    -Any country-related specific regulation that would prevent the subject from entering the study
    Fumatore attuale (sigaretta o sigaretta elettronica) o ex-fum con cessazione del fumo entro 1 anno prima della randomizzazione.
    Ex fum con storia di tabagismo >10 pacchetti-anno.
    Ipersensibilità nota a dupilumab o a uno qualsiasi degli eccipienti.
    Acutizzazione dell’asma durante lo screening, prima della randomizzazione.
    Broncospasmo acuto o stato asmatico in atto.
    Diagnosi di malattia polmon (diversa dall’asma) o sistemica associata a conte elevate di eosinofili periferici.
    Anamnesi o evidenza clinica di BPCO compresa la sindrome da sovrapposizione asma-BPCO (ACOS) o qualsiasi altra malattia polmon significativa (ad es. fibrosi polmonare, sarcoidosi, malattia polmonare interstiziale, ipertensione polmon, bronchiectasia, sindrome di Churg-Strauss).
    Tubercolosi attiva, tubercolosi latente non trattata o anamnesi di tubercolosi trattata in maniera incompleta o di infezione da microbatteri non tubercolari, a meno che non sia ben documentato da uno specialista che il partecipante sia stato adeguatamente trattato e possa ora iniziare il trattamento con un agente biologico secondo il giudizio medico dello sperimen e/o specialista di malattie infettive. Il test per la tubercolosi sarà effettuato in base al Paese, rispettando le prassi cliniche di routine e le linee guida locali se richiesto dalle autorità regolatorie o dai comitati etici.
    Anamnesi o evidenza in corso di malattia clinicamente significativa in qualsiasi organo non respiratorio (ad es. sistema cardiovascolare, nervoso, gastrointestinale, endocrinologico, reumatologico, dermatologico) che, a giudizio dello sperimen, potrebbe interferire con lo studio o richiedere un trattamento che potrebbe interferire con lo studio.
    Evidenza in corso di malattia oncologica clinicamente significativa che, secondo l’opinione dello sperimen, può interferire con gli obiettivi dello studio o sottoporre il soggetto a un rischio ingiustificato.
    Pz con uno dei seguenti risultati alla V1:
    • positività (o indeterminazione) per l’antigene di superficie del virus dell’epatite B (HBsAg) o
    • positività per l’anticorpo anti-core IgM del virus dell’epatite B (HBcAb) o
    • positività per l’HBcAb totale confermata da DNA HBV positivo o
    • positività per l’anticorpo anti-virus dell’epatite C (HCVAb) confermata da RNA HCV positivo.
    Anamnesi di infezione da virus dell’immunodeficienza umana (HIV) o sierologia HIV positiva alla V1.
    Qualsiasi terapia biologica (compresi i trattamenti sperimen e dupilumab) o qualsiasi altra terapia o immunosoppressore biologici nei 3 mesi precedenti la V1.
    Trattamento con un vaccino vivo (attenuato) nelle 12 settimane precedenti la V1.
    Trattamento cronico con corticosteroidi orali (OCS) per più di 2 settimane prima della V1.
    Arruolamento in altri studi in corso a prescindere dal prodotto sperimentale.
    Trattamento con un farmaco sperimen nelle 8 settimane o nelle 5 emivite (se note) precedenti la V1, in base al periodo di maggiore durata.
    Sospetto o alto rischio di infezione parassitaria (elmintica), salvo se la valutazione clinica e (se necessario) di laboratorio abbia escluso l’infezione attiva prima della randomizzazione.
    Donne in allattamento o in gravidanza.
    Individui ospitati presso un istituto per ragioni legali o normative, detenuti o soggetti istituzionalizzati per legge.
    Pz dipendenti dello sponsor o dello sperimen (in combinazione con la Sezione 1.61 dell’Ordinanza E6 delle GCP della Conferenza internazionale per l’armonizzazione (International Council for Harmonization, ICH).
    Pz dipendenti del centro dove si svolge lo studio clinico o altri soggetti direttamente coinvolti nella conduzione dello studio o loro familiari stretti.
    Sensibilità a uno qualsiasi dei trattamenti dello studio, a componenti dello stesso, al farmaco o altre allergie che, a giudizio dello sperimen, rappresentano una controindicazione alla partecipazione al presente studio.
    Qualsiasi normativa specifica a livello di singolo Paese che impedirebbe l’ingresso nello studio da parte del soggetto.
    E.5 End points
    E.5.1Primary end point(s)
    1/ Change from baseline to Week 24 in pre-bronchodilator FEV1
    2/ Percent change from baseline to Week 24 in regional airway volumes corrected for lung volume ([s]iVaw) at total lung capacity (TLC)
    1/ Variazione rispetto al basale del FEV1 pre-broncodilatatore alla Settimana 24
    2/ Variazione percentuale rispetto al basale dei volumi delle vie aeree regionali corretti per il volume polmonare ([s]iVaw) alla capacità polmonare totale (TLC) alla Settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    Dal basale alla settimana 24
    E.5.2Secondary end point(s)
    1/ Percent change from baseline to Week 24 in regional airway volumes corrected for lung volume ([s]iVaw) at functional residual capacity (FRC)
    2/ Percent change from baseline to Week 24 in regional airway resistance corrected for lung volume ([s]iRaw) at TLC
    3/ Percent change from baseline to Week 24 in regional airway resistance corrected for lung volume ([s]iRaw) at FRC
    4/ Change from baseline to Week 24 in lobar volumes (iVlobes) at TLC
    5/ Change from baseline to Week 24 in image-based ventilation/perfusion (iV/Q) at TLC
    6/ Change from baseline to Week 24 in HRCT-based internal airflow distribution (IAD)
    7/ Change from baseline to Week 24 in FeNO
    8/ Achievement of FeNO <25 parts per billion (ppb) at Week 24
    9/ Change from baseline to Week 24 in post-bronchodilator FEV1
    10/ Change from baseline to Week 24 in ACQ-7
    11/ Incidence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) including clinically significant changes in vital signs and laboratory abnormalities
    12/ Incidence of adverse events of special interest (AESI
    1. Variazione percentuale rispetto al basale dei volumi delle vie aeree regionali corretti per il volume polmonare ([s]iVaw) alla capacità funzionale residua (FRC) alla Settimana 24
    2. Variazione percentuale rispetto al basale della resistenza delle vie aeree regionali corretta per il volume polmonare ([s]iRaw) alla TLC alla Settimana 24
    3. Variazione percentuale rispetto al basale della resistenza delle vie aeree regionali corretta per il volume polmonare ([s]iRaw) alla FRC alla Settimana 24
    4. Variazione rispetto al basale dei volumi lobari (iVlobes) alla TLC alla Settimana 24
    5. Variazione rispetto al basale della ventilazione/perfusione basata su immagini diagnostiche (iV/Q) alla TLC alla Settimana 24
    6. Variazione rispetto al basale della distribuzione interna del flusso d’aria (IAD) basato su HRCT alla Settimana 24
    7. Variazione rispetto al basale del FeNO alla settimana 24
    8. Raggiungimento di un valore FeNO <25 parti per miliardo (ppb) alla Settimana 24
    9. Variazione rispetto al basale del FEV1 post-broncodilatatore alla Settimana 24
    10. Variazione rispetto al basale dell’ACQ-7 alla settimana 24
    11. Incidenza di eventi avversi emergenti dal trattamento (TEAE) ed eventi avversi seri (SAE), compresi cambiamenti clinicamente significativi dei segni vitali e anomalie di laboratorio
    12. Incidenza di eventi avversi di particolare interesse (AESI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 7/9/10 : Baseline to Week 24
    8 : Week 24
    11/12 : Baseline up to Week 36
    1 fino a 7/9/10 : dal basale alla settimana 24
    8 : settimana 24
    11/12 : dal basale fino alla settimana 36
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory
    ESPLORATIVA
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Saudi Arabia
    Taiwan
    United States
    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 years0
    E.8.9.1In the Member State concerned months17
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months21
    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: 340
    F.1.3Elderly (>=65 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 224
    F.4.2.2In the whole clinical trial 340
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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