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    Summary
    EudraCT Number:2019-001273-81
    Sponsor's Protocol Code Number:EFC15858
    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 number2019-001273-81
    A.3Full title of the trial
    Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic Non-Squamous Non-Small Cell Lung Cancer patients with CEACAM5 positive tumors
    Studio randomizzato, in aperto, di fase 3, di SAR408701 rispetto a Docetaxel in pazienti con neoplasia polmonare metastatica già trattata non a piccole cellule e a cellule non squamose con tumori positivi a CEACAM5
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAR408701 versus docetaxel in previously treated, Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) positive metastatic non-squamous non-small cell lung cancer patients
    SAR408701 rispetto a Docetaxel in pazienti precedentemente trattati con neoplasia polmonare metastatica non a piccole cellule e a cellule non squamose positiva alla molecola 5 di adesione cellulare correlata all’antigene carcinoembrionario (CEACAM5)
    A.3.2Name or abbreviated title of the trial where available
    CARMEN-LC03
    CARMEN-LC03
    A.4.1Sponsor's protocol code numberEFC15858
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1233-0781
    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 RECHERCHE E DEVELOPPEMENT
    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 recherche & développement
    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 nameNA
    D.3.2Product code [SAR408701]
    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.3.9.2Current sponsor codeSAR408701
    D.3.9.4EV Substance CodeSUB130908
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo coniugato maytansina anti-CEACAM 5.
    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.2.1.1.1Trade name Taxotere
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 [na]
    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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.2Current sponsor codena
    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.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
    Non-small cell lung cancer metastatic
    cancro del polmone non a piccole cellule metastatico
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer metastatic
    cancro del polmone non a piccole cellule metastatico
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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
    Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff date for each given analysis (progressive free survival [PFS] and overall survival [OS])
    Study success is defined either on PFS or OS
    The primary objective is to determine whether SAR408701 improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 >/=2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)
    The primary objective is to determine whether SAR408701 improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 >/=2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor
    Lo studio è disegnato con due endpoint primari che saranno analizzati sui partecipanti randomizzati al momento della data limite per ciascuna analisi (sopravvivenza libera da progressione [PFS] e sopravvivenza globale [OS])
    Il successo dello studio è definito in base a PFS o OS
    L’obiettivo primario è determinare se SAR408701 migliora la PFS rispetto a Docetaxel nei partecipanti con NSCLC non squamoso metastatico che esprime CEACAM5 con intensità >/=2+ in almeno il 50% della popolazione di cellule tumorali e precedentemente trattati con chemioterapia standard a base di platino e un inibitore del checkpoint immunitario (ICI)
    L’obiettivo primario è determinare se SAR408701 migliora la OS rispetto a Docetaxel nei partecipanti con NSCLC non squamoso metastatico che esprime CEACAM5 con intensità >/=2+ in almeno il 50% della popolazione di cellule tumorali e precedentemente trattati con chemioterapia standard a base di platino e un inibitore del checkpoint immunitario.
    E.2.2Secondary objectives of the trial
    • To compare the objective response rate (ORR) of SAR408701 with docetaxel
    • To compare the health related quality of life (HRQOL) of SAR408701 with docetaxel
    • To evaluate the safety of SAR408701 compared to docetaxel
    • To assess the duration of response (DOR) of SAR408701 compared to docetaxel.
    Confrontare il tasso di risposta obiettiva (ORR) di SAR408701 con Docetaxel
    Confrontare la qualità della vita correlata alla salute (HRQOL) di SAR408701 con Docetaxel
    Valutare la sicurezza di SAR408701 rispetto a Docetaxel
    Valutare la durata della risposta (DOR) di SAR408701 con Docetaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • At least 18 years of age or above (or countries legal age of maturity if above 18 years) and signed the informed consent.
    • Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease progression after platinum-based chemotherapy and immune checkpoint inhibitor.
    • Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of >/=2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50 % of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
    • At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    • A female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
    • A male participant who agrees to use effective contraception methods during and for at least 6 months after the last dose of study intervention
    Il partecipante deve avere almeno 18 anni (o aver raggiunto la maggiore età legale del Paese, se maggiore di 18 anni) al momento della firma del consenso informato.
    Diagnosi provata istologicamente o citologicamente di NSCLC non squamoso con progressione metastatica della malattia dopo chemioterapia a base di platino e inibitore del checkpoint immunitario.
    I partecipanti con espressione di CEACAM5 con intensità >/=2+ nel campione tumorale archiviato (o, se non disponibile, nel campione bioptico fresco) su almeno il 50% della popolazione di cellule tumorali, come dimostrato in modo prospettico da un test ICH centralizzato.
    Almeno una lesione misurabile secondo i criteri RECIST v1.1, come determinata dallo sperimentatore del centro locale/da valutazione radiologica.
    Performance status secondo l’Eastern Cooperative Oncology Group (ECOG) 0-1.
    Paziente di sesso femminile che accetti di utilizzare metodi contraccettivi durante il corso dello studio e per almeno 7 mesi dopo l’ultima dose del trattamento dello studio.
    Paziente di sesso maschile che accetti di utilizzare metodi contraccettivi durante il corso dello studio e per almeno 6 mesi dopo l’ultima dose del trattamento dello studio.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    • Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain within 4 weeks prior to the first dose of study intervention.
    • Significant concomitant illnesses, including all severe medical conditions that would impair the patient’s participation in the study or interpretation of the results.
    • History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
    • Non-resolution of any prior treatment related toxicity to < grade 2 according to NCI CTCAE V5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
    • History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
    • Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
    • Concurrent treatment with any other anticancer therapy.
    • Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5
    • Contraindication to use of corticosteroid premedication.
    • Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
    • Poor bone marrow, liver or kidney functions
    • Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
    In presenza di uno dei seguenti criteri i partecipanti saranno esclusi dallo studio:
    - Metastasi cerebrali non trattate e anamnesi di malattia leptomeningea. I pazienti con metastasi cerebrali precedentemente trattate possono partecipare, a condizione che non ci sia progressione documentata nelle 4 settimane precedenti la prima somministrazione del trattamento dello studio
    -Malattie concomitanti significative, comprese tutte le condizioni mediche gravi che ostacolerebbero la partecipazione del paziente allo studio o l'interpretazione dei risultati.
    - Anamnesi entro gli ultimi 3 anni di un tumore maligno invasivo diverso da quello trattato in questo studio, ad eccezione del carcinoma cutaneo basocellulare o squamocellulare sottoposto a resezione/ablazione e del carcinoma in situ della cervice o altri tumori locali considerati curati mediante trattamento locale.
    - Mancata risoluzione della tossicità correlata a trattamenti precedenti fino a < grado 2 in base ai criteri NCI CTCAE V5.0, eccetto per alopecia, vitiligine e tiroidite attiva controllata con terapia ormonale sostitutiva.
    - Anamnesi di malattie correlate alla sindrome da immunodeficienza acquisita (AIDS) o malattia da HIV nota che richieda trattamento antiretrovirale o infezione attiva da epatite.
    - Disturbi corneali irrisolti o qualsiasi precedente disturbo corneale. L’uso delle lenti a contatto non è consentito.
    - Trattamento concomitante con altra terapia antitumorale.
    - Precedente trattamento con Docetaxel o con con maytansinoide (coniugato anticorpo-farmaco DM1 o DM4) o terapia mirata contro CEACAM5.
    - Controindicazioni all'utilizzo di premedicazione a base di corticosteroidi.
    - Precedente arruolamento in questo studio e partecipazione attuale ad altri studi clinici che prevedano un trattamento sperimentale o altro tipo di ricerca medica.
    - Scarsa funzionalità del midollo osseo, del fegato e del rene.
    - Ipersensibilità a uno qualsiasi dei trattamenti dello studio, a componenti dello stesso (EDTA), al farmaco (paclitaxel, polisorbato 80) o altre allergie che, a giudizio dello sperimentatore, rappresentano una controindicazione alla partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    1- Progression free survival (PFS) : PFS will be defined as the time from randomization to the date of the first documented disease progression or death of any cause, whichever comes first
    2- Overall Survival (OS) : OS will be defined as the time of randomization to the date of death due to any cause
    1. Sopravvivenza libera da progressione (PFS): la PFS sarà definita come il tempo che intercorre tra la randomizzazione e la data della prima progressione documentata della malattia o decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo.
    2. Sopravvivenza globale (OS): OS sarà definito come il tempo dalla randomizzazione alla data del decesso per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Baseline to up to approximately 15 months
    2- Baseline up to approximately 2 years.
    1 - Dal basale a circa 15 mesi
    2- Dal basale a circa 2 anni.
    E.5.2Secondary end point(s)
    1- Objective response rate (ORR) : Objective response rate will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response derived from Overall Response (OR) determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
    2- Health Related Quality of Life (HRQOL) - disease related symptoms: Time to deterioration (TTD) in disease related symptoms as determined by European Organization for Research and Treatment for Cancer (EORTC)- Quality of life Questionnaire (QLQ)-Lung Cancer (LC)13
    3- Health related quality of life (HRQOL) - physical function: TTD in physical function as determined by EORTC QLQ C30
    4- Health related quality of life (HRQOL) - role function: TTD in role function as determined by EORTC QLQ C30
    5- Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs): Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI CTCAE V5
    6- Duration of response (DOR) : Duration of response (DOR) is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first.
    1 Tasso di risposta obiettiva: il tasso di risposta obiettiva sarà definito come la percentuale di partecipanti che hanno una risposta completa (CR) o una risposta parziale (PR), come migliore risposta complessiva derivata dalla risposta complessiva (OR) determinata dall’IRC secondo i criteri RECIST 1.1
    2 Qualità della vita correlata alla salute (HRQOL) - sintomi correlati alla malattia: Tempo di deterioramento (TTD) nei sintomi correlati alla malattia, come determinato (EORTC-QLQ-LC13)
    3 Qualità della vita correlata alla salute (HRQOL) - funzione fisica: Tempo di deterioramento (TTD) nella funzione fisica, come determinato da EORTC QLQ C-30
    4 Qualità della vita correlata alla salute (HRQOL) - funzione del ruolo: Tempo di deterioramento nella funzione del ruolo, come determinato da EORTC QLQ C30
    5 Numero di pazienti con eventi avversi emergenti durante il trattamento (TEAE) ed eventi avversi seri (SAE): Incidenza di TEAE e SAE e anomalie di laboratorio in base ai criteri NCI CTCAE V5
    6 Durata della risposta (DOR): la durata della risposta (DOR) è definita come il tempo dalla prima evidenza documentata di risposta completa (CR) o risposta parziale (PR) fino a progressione della malattia (PD) come determinato dai criteri RECIST 1.1 o decesso per qualsiasi causa, a seconda di quale evento si verifichi prima
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Baseline up to approximately 2 years
    2-3-4- Baseline up to median 12 months
    5- Baseline up to end of study (approximately 2 years).
    6- Baseline up to approximately 2 years
    1 Dal basale a circa 2 anni
    2-3-4 Dal basale fino a 12 mesi mediani
    5 Dal basale alla fine dello studio (circa 2 anni).
    6 Dal basale fino a circa 2 anni
    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 Yes
    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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Chile
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    Argentina
    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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days1
    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: 433
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 217
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    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)
    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 Decision2020-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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