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    Summary
    EudraCT Number:2019-003582-18
    Sponsor's Protocol Code Number:20190009
    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 number2019-003582-18
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
    Studio di fase III, multicentrico, randomizzato, in aperto, con controllo attivo su AMG 510 rispetto a docetaxel per il trattamento di soggetti con NSCLC localmente avanzato e non resecabile o metastatico trattato in precedenza con mutazione p.G12C di KRAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Compare AMG 510 With Docetaxel in NSCLC Subjects With KRAS p.G12C Mutation (CodeBreak 200)
    studio di fase III volto a confrontare AMG 510 e docetaxel in soggetti con NSCLC e mutazione p.G12C di KRAS (CodeBreak 200)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number20190009
    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 SponsorAMGEN 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@amgen.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 nameAMG 510
    D.3.2Product code [AMG 510]
    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.3.9.2Current sponsor codeAMG 510
    D.3.9.4EV Substance CodeSUB193887
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedocetaxel
    D.3.2Product code [docetaxel]
    D.3.4Pharmaceutical form Concentrate for 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 INNDOCETAXEL
    D.3.9.2Current sponsor codedocetaxel
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DECADRON - 0.5 MG COMPRESSE 10 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderFARMACEUTICI CABER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDecadron
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form 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 INNDESAMETASONE
    D.3.9.2Current sponsor codeDesametasone
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with KRAS p.G12C mutation
    Carcinoma polmonare non a piccole cellule localmente avanzato e non resecabile o metastatico (NSCLC) con mutazione KRAS p.G12C precedentemente trattato
    E.1.1.1Medical condition in easily understood language
    Previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with KRAS p.G12C mutation
    Carcinoma polmonare non a piccole cellule localmente avanzato e non resecabile o metastatico (NSCLC) con mutazione KRAS p.G12C precedentemente trattato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of AMG 510 versus docetaxel as assessed by progression-free survival (PFS) in previously treated subjects with KRAS p.G12C mutated nonsmall cell lung cancer (NSCLC)
    Confrontare l'efficacia di AMG 510 rispetto a docetaxel in termini di sopravvivenza libera da progressione (PFS) in soggetti precedentemente trattati con carcinoma polmonare non a piccole cellule (NSCLC) con mutazione KRAS p.G12C
    E.2.2Secondary objectives of the trial
    •To compare the efficacy of AMG 510 Versus docetaxel as assessed by:
    - Overall Survival (OS)
    - Objective response rate (ORR)
    •To compare patient-reported outcomes (PRO) as assessed by:
    - European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 13 (EORTC QLQ-LC13) and European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30)
    •To compare efficacy of AMG 510 versus docetaxel as assessed by:
    - duration of response (DOR), time to response (TTR), and disease control rate (DCR)
    •To compare the safety and tolerability of AMG 510 versus docetaxel
    •To compare the effect of treatment with AMG 510 on other treatment and disease related symptoms, and health related quality of life relative to docetaxel
    •To characterize the pharmacokinetics (PK) of AMG 510 and its major metabolites
    Mettere a confronto l’efficacia di AMG 510 rispetto a docetaxel in termini di:
    - sopravvivenza globale (OS)
    - tasso di risposta obiettiva (ORR)
    Mettere a confronto gli esiti riferiti dai pazienti (PRO) valutati mediante:
    - questionario EORTC QLQ-LC13 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Lung Cancer 13) e questionario EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30)
    Mettere a confronto l’efficacia di AMG 510 rispetto a docetaxel in termini di:
    - durata della risposta (DOR), tempo alla risposta (TTR) e tasso di controllo della malattia (DCR)
    Mettere a confronto:
    la sicurezza e la tollerabilità di AMG 510 rispetto a docetaxel
    l’effetto del trattamento con AMG 510 sugli altri sintomi correlati al trattamento e alla malattia e sulla qualità di vita correlata alla salute rispetto a docetaxel
    Caratterizzare la farmacocinetica (PK) di AMG 510 e dei suoi principali metaboliti
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: Amendment 1
    Date: 21/01/2020
    Title: Protocol - Sec. 8.2.7.5
    Objectives: These optional pharmacogenetic analyses focus on using inherited genetic variations to more accurately define tumor specific (somatic) mutations which will be correlated to response. These germline variations may also be used to evaluate their possible correlation to the disease and/or responsiveness to the therapies used in this study.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional sub-study within current protocol. Sub-study Assessing Exploratory Biomarkers in Tumor Biopsies at Progression. In order to better understand mechanisms of resistance, any patients with lesions amenable to biopsy will be invited to participate in this sub-study at the discretion of the investigators.

    Farmacogenetica
    Versione: Amendment 1
    Data: 21/01/2020
    Titolo: Protocollo - Sez. 8.2.7.5
    Obiettivi: Queste analisi farmacogenetiche opzionali si concentrano sull'uso delle variazioni genetiche ereditate per definire in modo più preciso le mutazioni specifiche (somatiche) del tumore che saranno correlate alla risposta. Queste variazioni germinali possono anche essere utilizzate per valutare la loro possibile correlazione con la malattia e/o la risposta alle terapie utilizzate in questo studio.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sotto-studio opzionale all'interno del protocollo corrente. Sotto-studio di valutazione dei biomarcatori esplorativi nelle biopsie tumorali a progressione. Al fine di comprendere meglio i meccanismi di resistenza, tutti i pazienti con lesioni suscettibili di biopsia saranno invitati a partecipare a questo sotto-studio a discrezione dei ricercatori.
    E.3Principal inclusion criteria
    • Subject or subject's legally acceptable representative has provided informed consent prior to initiation of any study specific activities/procedures.
    • Age > = 18 years of age
    • Have documentation of KRAS p.G12C mutation confirmed by central testing through the current protocol or Amgen Study 20190294 prior to enrollment.
    • Subjects will have received and progressed or experienced disease recurrence on or after at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. Prior treatment must include a platinum-based doublet chemotherapy and checkpoint inhibitor for advanced or metastatic disease, either given as one line of therapy or as individual lines of therapy unless the subject has a medical contraindication to one of the required therapies. If the subject has a medical contraindication to a required therapy, the subject may be enrolled only after the investigator discusses and obtains approval from the Amgen medical monitor.
    a) Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
    b) In locally advanced and unresectable NSCLC, disease progression on or within 6 months of end of prior curatively intended multimodal therapy will count as a line of therapy. If chemoradiation is followed by planned systemic therapy without documented progression between chemoradiation and systemic therapy, the entire treatment course counts as one line of therapy.

    *Please, refers to the protocol for the full list
    - i soggetti o il loro rappresentante legale devono fornire il consenso informato prima di qualsiasi attività/procedura studio specifica
    - età > = 18 anni
    - i soggetti presentano una mutazione p.G12C di KRAS confermata tramite test centralizzato secondo quanto riportato dal protocollo per lo studio Amgen 20190294 prima dell'arruolamento
    - i soggetti avranno ricevuto una recidiva  della malattia o saranno in progressione dopo aver ricevuto almeno 1 precedente terapia sistemica per malattia localmente avanzata e non resecabile o metastatica. Il trattamento precedente deve includere una chemioterapia con doppietta a base di platino e un checkpoint inibitore per malattia avanzata o metastatica, entrambi somministrati come unica linea di trattamento o come monoterapia singola a meno che il paziente non abbia controindicazioni mediche ad una delle terapie richieste. Se il paziente presenta una controindicazione medica verso una terapia richiesta, deve essere arruolato solo dopo che l'investigatore ha discusso e ottenuto l'approvazione dal medical monitor Amgen.
    a) La terapia adiuvante conterà come una linea di terapia se il soggetto è progredito entro 6 mesi dalla somministrazione della stessa.
    b) In NSCLC localmente avanzato e non resecabile, la progressione della malattia durante o entro 6 mesi dalla fine del precedente trattamento inteso come terapia multimodale verrà considerato come una linea di trattamento. Se la chemoradiazione è seguita da terapia sistemica pianificata senza progressione documentata tra la chemoradiazione e la terapia sistemica, l'intero trattamento conta come unica linea di terapia.

    *Fare riferimento al protocollo per la lista completa
    E.4Principal exclusion criteria
    • Subjects have received prior docetaxel in unresectable or metastatic setting.
    • Mixed small-cell lung cancer and NSCLC histology
    • Previously identified driver mutation (according to local standard of care or guidelines) other than KRAS p.G12C for which an approved therapy is available (including EGFR, ALK, etc).
    • Active brain metastases. Subjects who have had brain metastases resected or have received whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 weeks) prior to study day 1 are eligible if they meet all of the following criteria:
    a) residual neurological symptoms grade < = 2;
    b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and
    c) follow-up MRI performed within 30 days prior to enrollment shows no progression or new lesions appearing.
    • Leptomeningeal disease.
    • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Subjects with PleurX catheters in place may be considered for the study with Medical Monitor approval.

    *Please, refers to protocol for the full list.
    - i pazienti hanno ricevuto un precedente trattamento con docetaxel in condizioni non resecabili o metastatiche
    - istologia mista di tumore al polmone a piccole cellule e non
    - mutazione (secondo lo standard of care locale o le lineguida) del driver diversa da KRAS p.G12C identificata precedentemente per la quale è disponibile una terapia approvata (incluso EGFR, ALK etc.)
    - metastasi cerebrali attive. I soggetti che hanno avuto resezioni metastatiche al cervello o che hanno ricevuto la radioterapia a tutto il cervello terminando almeno 4 settimane (o radiochirurgia stereotassica che termina almeno 2 settimane) prima del giorno di studio 1 sono ammissibili se soddisfano tutti i seguenti criteri:
    a. grado dei sintomi neurologici residui < = 2;
    b. a dosi stabili di desametasone o equivalente per almeno 2 settimane, se applicabile;
    c. la risonanza magnetica di follow-up eseguita entro 30 giorni prima dell'arruolamento non mostra alcuna progressione o comparsa di nuove lesioni.
    - malattia leptomeningea
    - versamento pleurico non controllato, versamento pericardico o ascite che richiedono procedure di drenaggio ricorrenti a una frequenza superiore ad una volta al mese. I soggetti con cateteri PleurX in posizione possono essere considerati per lo studio con l'approvazione di Medical Monitor.

    * Fare riferimento al protocollo per la lista completa.
    E.5 End points
    E.5.1Primary end point(s)
    PFS - defined as time from randomization until disease progression or death from any cause, whichever occurs first for all subjects.
    PFS – definita come il tempo intercorrente tra la randomizzazione e la progressione di malattia o il decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo, per tutti i soggetti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timing for the PA of PFS will be event driven. PFS early success is achieved in the IA, the IA will serve the purpose of PA of PFS. The final analysis of the study will be done when the last subject completes LTFU.
    Le tempistiche per l'analisi primaria (PA) della PFS saranno guidate dagli eventi. Il successo iniziale di PFS si ottiene dalle analisi ad interim (IA). L'IA servirà allo scopo di PA di PFS. L'analisi finale dello studio verrà fatta quando l'ultimo soggetto avrà completato il LTFU.
    E.5.2Secondary end point(s)
    • Overall survival - defined as time from randomization until death from any cause.
    • Objective response (complete response [CR] + partial response [PR]), assessed per RECIST v1.1. Response will be assessed by BICR.
    • Change from baseline over time to week 12 in disease related symptoms of:
    o Dyspnea as measured by a 4 item dyspnea domain from QLQ-C30 and QLQ-LC13
    o Cough as measured by QLQ-LC13
    o Chest Pain as measured by QLQ-LC13
    • Change from baseline over time to week 12 in
    o Physical functioning as measured by QLQ-C30
    o Global health status as measured by QLQ-C30
    • Duration of response - defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first.
    - Sopravvivenza globale – definita come il tempo intercorrente tra la randomizzazione e il decesso per qualsiasi causa.
    - Risposta obiettiva (risposta completa [CR] + risposta parziale [PR]) secondo i criteri RECIST v1.1. La risposta sarà valutata mediante BICR.
    - Variazione dal basale alla settimana 12 dei sintomi correlati alla malattia:
    o dispnea misurata tramite un dominio a 4 item relativo alla dispnea nei questionari QLQ-C30 e QLQ-LC13
    o tosse misurata tramite QLQ-LC13
    o dolore toracico misurato tramite QLQ-LC13
    - Variazione dal basale alla settimana 12 di:
    o funzionalità fisica misurata tramite QLQ-C30
    o stato di salute globale misurato tramite QLQ-C30
    - Durata della risposta – definita come il tempo intercorrente tra la prima evidenza di PR o CR e la progressione di malattia o il decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timing for the PA of PFS will be event driven. PFS early success is achieved in the IA, the IA will serve the purpose of PA of PFS.
    The final analysis of the study will be done when the last subject completes LTFU.
    La rilevazione della PA della PFS sarà evento guidata. Il successo iniziale di PFS si ottiene nell'IA, l'IA servirà allo scopo della PA di PFS.
    L'analisi finale dello studio sarà eseguita quando l'ultimo soggetto avrà completato la LTFU.
    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 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) 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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    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
    China
    Japan
    Korea, Democratic People's Republic of
    Russian Federation
    Taiwan
    United States
    Belgium
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    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
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, LTFU, additional antibody testing), as applicable.
    La data di fine studio è definita come la data in cui l'ultimo soggetto tra tutti i siti viene valutato o riceve un intervento per la valutazione nello studio (per es: ultimo soggetto ultima visita), seguendo eventuali parti aggiuntive dello studio (ad esempio, LTFU, test anticorpali aggiuntivi), a seconda dei casi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 150
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 650
    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)
    NA
    NA
    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 Decision2020-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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