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    Summary
    EudraCT Number:2020-000845-15
    Sponsor's Protocol Code Number:GCT3013-02
    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:2021-08-30
    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 number2020-000845-15
    A.3Full title of the trial
    A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma
    Sperimentazione di Fase 1b/2, in aperto per valutare la sicurezza e l’efficacia preliminare di epcoritamab (GEN3013; DuoBody® CD3xCD20) in combinazione con altri agenti in soggetti con linfoma non Hodgkin a cellule B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma
    Sperimentazione sulla sicurezza e sull’efficacia delle combinazioni di epcoritamab in soggetti con linfoma non Hodgkin a cellule B
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberGCT3013-02
    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 SponsorGENMAB A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportGenmab US, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.6E-mailregulatory@genmab.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 nameEpcoritamab
    D.3.2Product code [GEN3013]
    D.3.4Pharmaceutical form Concentrate and solvent for 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 INNEpcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameGEN3013 (DuoBody®-CD3xCD20)
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    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 nameEpcoritamab
    D.3.2Product code [GEN3013]
    D.3.4Pharmaceutical form Concentrate and solvent for 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 INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameGEN3013 (DuoBody®-CD3xCD20)
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    B-cell Non-Hodgkin Lymphoma
    Diffuse large B-cell lymphoma
    Non-Hodgkin lymphoma
    Follicular lymphoma
    Linfoma Non-Hodgkin a cellule B
    Linfoma diffuso a grandi cellule B
    Linfoma Non-Hodgkin
    Linfoma Follicolare
    E.1.1.1Medical condition in easily understood language
    Lymphoma of B-cell origin
    Linfoma di origine delle cellule B
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose Escalation Phase: Evaluate the safety and tolerability of epcoritamab in combination with other agents

    Expansion Phase: Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents
    Fase di run-in di sicurezza: valutare la sicurezza e la tollerabilità di epcoritamab in combinazione con altri agenti
    Fase di espansione: valutare l’attività antitumorale preliminare di epcoritamab in combinazione con altri agenti
    E.2.2Secondary objectives of the trial
    Dose Escalation Phase:
    - Characterize the pharmacokinetic (PK) properties of epcoritamab
    - Evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab
    - Evaluate immunogenicity
    - Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents

    Expansion Phase:
    - Further assess the preliminary anti-tumor activity of epcoritamab in combination with other agents
    - Further evaluate the safety and tolerability of epcoritamab in combination with other agents
    - Characterize the PK properties of epcoritamab
    - To evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab
    - Evaluate immunogenicity
    Fase di run-in di sicurezza:
    - Caratterizzare le proprietà di farmacocinetica (PK) di epcoritamab
    - Valutare i marcatori farmacodinamici correlati all’efficacia e al meccanismo d’azione di epcoritamab
    - Valutare l’immunogenicità
    - Valutare l’attività antitumorale preliminare di epcoritamab in combinazione con altri agenti
    Fase di espansione:
    - Valutare ulteriormente l’attività antitumorale preliminare di epcoritamab in combinazione con altri agenti
    - Valutare ulteriormente la sicurezza e tollerabilità di epcoritamab in combinazione con altri agenti
    - Caratterizzare le proprietà di farmacocinetica (PK) di epcoritamab
    - Valutare i marcatori farmacodinamici correlati all’efficacia e al meccanismo d’azione di epcoritamab
    - Valutare l’immunogenicità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must sign an ICF
    2. At least 18 years of age
    3. Measurable disease defined as =1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or =1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
    4. ECOG PS score of 0,1 or 2
    5. Acceptable organ function at screening
    6. CD20-positive NHL at most recent representative tumor biopsy
    7. If of childbearing potential subject must practicing a highly effective method of birth control
    8. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
    9. Life expectancy >2 months with SOC treatment.
    Arm 1: One of these confirmed histologies
    - DLBCL, NOS
    - "double-hit" or "triple-hit" DLBCL
    - FL Grade 3B
    Arm 2: R/R FL
    Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
    Arm 4: One of these confirmed histologies and eligible for HDT-ASCT
    - DLBCL, NOS
    - "double-hit" or "triple-hit" DLBCL
    - FL Grade 3B
    Arm 5:One of these confirmed histologies and ineligible for HDT-ASCT
    - DLBCL, NOS
    - "double-hit" or "triple-hit" DLBCL
    - FL Grade 3B
    1. Il soggetto deve firmare un modulo di consenso informato
    2. Almeno 18 anni di età
    3. Malattia misurabile, definita come =1 lesione nodale misurabile (asse lungo >1,5 cm e asse corto >1,0 cm) o =1 lesione extranodale misurabile (asse lungo >1,0 cm) alla TAC o RM
    4. Stato di validità ECOG pari a 0,1 o 2
    5. Funzionalità degli organi accettabile allo screening
    6. LNH positivo per CD20 alla più recente biopsia tumorale rappresentativa
    7. Se in età fertile, il soggetto deve adottare un metodo di controllo delle nascite altamente efficace
    8. Un uomo con vita sessuale attiva con una donna in età fertile deve accettare di utilizzare un metodo anticoncezionale a barriera
    9. Aspettativa di vita maggiore di 2 mesi con trattamento SOC
    Braccio 1: una delle seguenti istologie documentate:
    - DLBCL, NOS
    -"double-hit" o "triple-hit" DLBCL
    - FL di grado 3B
    Braccio 2: LF R/R
    Braccio 3: LF di grado 1-3A di recente diagnosi, non trattato precedentemente
    Braccio 4: una delle seguenti istologie documentate e idonee per HDT-ASCT
    - DLBCL, NOS
    -"double-hit" o "triple-hit" DLBCL
    - FL di grado 3B
    Braccio 5: una delle seguenti istologie documentate e non idonee per HDT-ASCT
    - DLBCL, NOS
    - "double-hit" o "triple-hit" DLBCL
    - FL di Grado 3B
    E.4Principal exclusion criteria
    1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
    2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
    3. Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
    4. Clinically significant cardiovascular disease
    5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
    6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
    7. Active HBV or HBC (DNA PCR positive infection)
    8. Known history of seropositivity of human immunodeficiency virus(HIV)
    9. Suspected active or latent tuberculosis
    1. Chemioterapia, radioterapia o intervento chirurgico maggiore nelle 4 settimane precedenti la prima dose di epcoritamab
    2. Qualsiasi trattamento precedente con un anticorpo bispecifico con target CD3 e CD20
    3. Trattamento con terapia CAR-T terapia nei 30 giorni precedenti la prima dose di epcoritamab
    4. Cardiopatia clinicamente significativa
    5. Evidenza di malattie concomitanti significative e non controllate che potrebbero influire sulla conformità con il protocollo o l’interpretazione dei risultati
    6. Linfoma del SNC o coinvolgimento noto del SNC da parte del linfoma allo screening, confermati da una RM/TAC cerebrale e, se clinicamente indicato, da puntura lombare
    7. HBV o HBC attivi (Infezione positiva DNA PCR)
    8. Anamnesi di positività agli anticorpi dell’HIV
    9. Sospetto di tubercolosi attiva o latente
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation Phase:
    - Incidence of dose-limiting toxicities
    - Incidence and severity of adverse events (AEs)
    - Incidence and severity of changes in laboratory values
    - Incidence of dose interruptions and delays

    Expansion Phase:
    - ORR determined by Lugano criteria
    Fase di run-in di sicurezza:
    - Incidenza delle tossicità limitanti la dose
    - Incidenza e gravità degli eventi avversi (EA)
    - Incidenza e gravità delle modifiche nei valori di laboratorio
    - Incidenza delle interruzioni e ritardi nella dose

    Fase di espansione:
    - ORR determinato mediante i criteri di Lugano
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT evaluation period is defined as the first 4 weeks, ie, 28 days after the first administration of epcoritamab.
    For the other end points, please refer to protocol
    Il periodo di valutazione delle tossicità limitanti la dose (DLT) è definito come le prime 4 settimane, ovvero 28 giorni dopo la prima somministrazione di epcoritamab.
    Per gli altri endpoint secondari, si prega di far riferimento al protocollo
    E.5.2Secondary end point(s)
    Dose Escalation Phase:
    - PK parameters (clearance, volume of distribution, area under-the-concentration-time curve (AUC0-Clast and AUC0-8), maximum concentration (Cmax), time of Cmax (Tmax), predose values, and half-life)
    - Pharmacodynamic markers in blood samples and within tumor (on-treatment biopsy)
    - Incidence of anti-drug antibodies (ADAs) to epcoritamab
    - ORR determined by Lugano criteria
    - Duration of response (DOR) determined by Lugano criteria
    - Time to response (TTR) determined by Lugano criteria
    - Progression-free survival (PFS) determined by Lugano criteria
    - ORR determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
    - DOR determined by LYRIC
    - TTR determined by LYRIC
    - PFS determined by LYRIC
    - Overall survival (OS)
    - Time to next anti-lymphoma therapy (TTNT)
    - Rate and duration of minimal residual disease (MRD) negativity

    Expansion Phase:
    - DOR determined by Lugano criteria
    - TTR determined by Lugano criteria
    - PFS determined by Lugano criteria
    - ORR determined by LYRC
    - DOR determined by LYRIC
    - TTR determined by LYRIC
    - PFS determined by LYRIC
    - OS
    - TTNT
    - Rate and duration of MRD negativity
    - Incidence and severity of AEs
    - Incidence and severity of changes in laboratory values
    - Incidence of dose interruptions and delays
    - PK parameters (clearance, volume of distribution, AUC0-last, AUC0-8, Cmax, Tmax, predose values, and
    t½)
    - Pharmacodynamic markers in blood samples and within tumor (on-treatment biopsy)
    - Incidence of ADAs to epcoritamab
    Fase di run-in di sicurezza:
    - Parametri di farmacocinetica (PK) (clearance, volume di distribuzione, area sotto la curva concentrazione/tempo (AUC0-Clast e AUC0-8), concentrazione massima (Cmax), tempo di Cmax (Tmax), valori pre-dose ed emivita)
    - Marcatori di farmacodinamica nei campioni di sangue e nel tumore (biopsia durante il trattamento)
    - Incidenza degli anticorpi anti-farmaco (ADA) contro epcoritamab
    - ORR determinato mediante i criteri di Lugano
    - Durata della risposta (DOR) determinata mediante i criteri di Lugano
    - Tempo alla risposta (TTR) determinato mediante i criteri di Lugano
    - Sopravvivenza libera da progressione (PFS) determinata mediante i criteri di Lugano
    - ORR determinato dalla risposta del linfoma alla terapia immunomodulatoria
    Criteri della terapia (LYRIC)
    - DOR determinato da LYRIC
    - TTR determinato da LYRIC
    - PFS determinata da LYRIC
    - Sopravvivenza complessiva (OS)
    - Tempo alla terapia anti-linfoma successiva (TTNT)
    - Tasso e durata di negatività della malattia minima residua (MRD)
    Fase di espansione:
    - ORR determinato mediante i criteri di Lugano
    - TTR determinato mediante i criteri di Lugano
    - PFS determinata mediante i criteri di Lugano
    - ORR determinato da LYRIC
    - DOR determinato da LYRIC
    - TTR determinato da LYRIC
    - PFS determinata da LYRIC
    - OS
    - TTNT
    - Tasso e durata di negatività della MRD
    - Incidenza e gravità degli EA
    - Incidenza e gravità delle modifiche nei valori di laboratorio
    - Incidenza delle interruzioni e ritardi nella dose
    - Parametri di farmacocinetica (PK) (clearance, volume di distribuzione, AUC0-last, AUC0-8, Cmax, Tmax, valori pre-dose e
    t½)
    - Marcatori di farmacodinamica nei campioni di sangue e nel tumore (biopsia durante il trattamento)
    - Incidenza di ADA contro epcoritamab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol
    Si prega di fare riferimento al protocollo
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b
    Fase 1b
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    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 trial5
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    United States
    Belgium
    Denmark
    Finland
    France
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    Czechia
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    elderly
    anziani
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 150
    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)
    When a patient is no longer in the trial, further treatment is at the discretion of the patient's doctor.
    Quando un paziente non è più nello Studio, l'ulteriore trattamento è a discrezione del medico del paziente
    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 Decision2021-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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