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    Summary
    EudraCT Number:2021-001966-39
    Sponsor's Protocol Code Number:CBYL719C2303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001966-39
    A.3Full title of the trial
    EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor
    EPIK-B5: Un estudio de fase III, aleatorizado, doble ciego y controlado con placebo de alpelisib en combinación con fulvestrant para hombres y mujeres posmenopáusicas con cáncer de mama avanzado HR positivo, HER2 negativo con mutación en PIK3CA, que ha progresado durante o después del tratamiento con un inhibidor de la aromatasa y un inhibidor de CDK4/6.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the efficacy of alpelisib plus fulvestrant in participants with HR-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitor
    Estudio para evaluar la eficacia de alpelisib más fulvestrant en participantes con cáncer de mama avanzado HR positivo, HER2 negativo después del tratamiento con un inhibidor de CDK4/6 y un inhibidor de la aromatasa.
    A.3.2Name or abbreviated title of the trial where available
    EPIK-B5
    A.4.1Sponsor's protocol code numberCBYL719C2303
    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 SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Piqray
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 namealpelisib
    D.3.2Product code BYL719
    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.3.8INN - Proposed INNALPELISIB
    D.3.9.1CAS number 1217486-61-7
    D.3.9.2Current sponsor codeBYL719
    D.3.9.4EV Substance CodeSUB180707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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 Piqray
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 namealpelisib
    D.3.2Product code BYL719
    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.3.8INN - Proposed INNALPELISIB
    D.3.9.1CAS number 1217486-61-7
    D.3.9.2Current sponsor codeBYL719
    D.3.9.4EV Substance CodeSUB180707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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.2.5The 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 namefulvestrant
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfulvestrant
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hormone receptor positive, HER2-negative advanced breast cancer
    Cáncer de mama avanzado HR positivo, HER2 negativo
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer that is distinguished from other breast cancer types by stage and the presence of molecules that respond to certain hormones
    Cáncer de mama avanzado que se distingue de otros tipos de cáncer de mama por el estadio y la presencia de moléculas que responden a determinadas hormonas
    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 LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to treatment with placebo plus fulvestrant
    Confirmar si el tratamiento con alpelisib en combinación con fulvestrant prolonga la supervivencia libre de progresión (SLP) en comparación con placebo en combinación con fulvestrant
    E.2.2Secondary objectives of the trial
    To determine whether treatment with alpelisib plus fulvestrant prolongs overall survival (OS) compared to treatment with placebo plus fulvestrant

    To evaluate alpelisib plus fulvestrant compared to placebo plus fulvestrant, with regards to objective response by RECIST 1.1 criteria

    To evaluate the association between PIK3CA mutation status as measured in circulating tumor deoxyribonucleic acid (ctDNA) at baseline with PFS upon treatment with alpelisib

    To assess safety and tolerability of alpelisib in combination with fulvestrant compared to placebo in combination with fulvestrant

    To evaluate treatment with alpelisib plus fulvestrant compared to placebo plus fulvestrant, with respect to time to deterioration of Eastern Cooperative Oncology Group (ECOG) performance status

    To evaluate patient-reported outcomes of alpelisib plus fulvestrant compared to placebo and fulvestrant

    To explore the long-term benefit intermediate to PFS and OS
    Evaluar alpelisib más fulvestrant en comparación con placebo más fulvestrant, respecto a la supervivencia global (OS)

    Evaluar alpelisib más fulvestrant en comparación con placebo más fulvestrant, con respecto a la respuesta objetiva según los criterios RECIST 1.1

    Evaluar la asociación entre el estado de la mutación en PIK3CA según el ácido desoxirribonucleico tumoral circulante (ADNtc) en estado basal y la SLP tras el tratamiento con alpelisib.

    Evaluar la seguridad y tolerabilidad de alpelisib en combinación con fulvestrant en comparación con placebo en combinación con fulvestrant

    Evaluar el tratamiento con alpelisib más fulvestrant en comparación con placebo más fulvestrant, respecto al tiempo hasta el deterioro del estado funcional - ECOG

    Evaluar los resultados comunicados por el paciente de alpelisib más fulvestrant en comparación con placebo y fulvestrant

    Explorar el beneficio intermedio a largo plazo en relación con la PFS y la OS según la PFS2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant is an adult >/= 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
    - Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
    - Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing
    - Participant has at least one measurable lesion as per RECIST v1.1 criteria as assessed by BIRC (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).
    - Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).
    - Participant has received </= 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy).
    - The presence of a PIK3CA mutation(s) determined by tissue either by a local laboratory using only CE-marked IVD assays such as QIAGEN Therascreen® PIK3CA RGQ PCR test or by a Novartis designated laboratory.
    - If female, then the participant must be in postmenopausal status

    Further inclusion criteria and details are described in the protocol
    - Participantes adultos >/= 18 años de edad en el momento en que se obtenga el consentimiento informado y que lo hayan firmado antes de realizar cualquier actividad relacionada con el ensayo y según las directrices locales.
    - Participantes con diagnóstico histológica o citológicamente confirmado de cáncer de mama
    RE+ y/o RPg+ mediante pruebas analíticas locales.
    - Participantes con cáncer de mama HER2 negativo definido como un resultado negativo en
    la prueba de hibridización in situ o un estado 0, 1+ o 2+ de IHQ. Si IHQ es 2+, se requerirá una
    hibridación in situ (hibridación fluorescente in situ [FISH], hibridación cromogénica in situ
    [CISH] o hibridación con plata in situ [SISH]) negativas realizadas en un laboratorio local.
    - Participantes con al menos una lesión medible según los criterios RECIST 1.1 y según el
    BIRC (una lesión en un lugar previamente irradiado solo se podrá considerar una lesión diana
    en caso de existir signos claros de progresión desde la irradiación).
    - Participantes con recurrencia o progresión de la enfermedad durante o después del
    tratamiento con un IA (es decir, letrozol, anastrozol, exemestano) en combinación con un
    inhibidor de CDK4/6. No es necesario que el tratamiento con un IA combinado con un inhibidor de CDK4/6 sea la última pauta del tratamiento (incluido el tratamiento adyuvante).
    - Participantes que han recibido </= 1 línea de tratamiento anterior con quimioterapia (excepto quimioterapia neoadyuvante/adyuvante).
    - La presencia de mutación(es) en PIK3CA determinada(s) por el tejido en un laboratorio local
    que utiliza solo pruebas de diagnóstico in vitro con marcado CE como QIAGEN Therascreen®
    PIK3CA RGQ PCR o en un laboratorio designado por Novartis.
    - Si es una mujer, debe estar en estado posmenopáusico.

    Más criterios de inclusión y detalles se describen en el protocolo.
    E.4Principal exclusion criteria
    - Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the investigator’s best judgment.
    - Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
    - Participant has received prior treatment with fulvestrant, any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor

    Further exclusion criteria and details are described in the protocol
    - Participantes con enfermedad visceral sintomática o cualquier carga de enfermedad que
    haga a el participante no elegible para la terapia endocrina (TE) según el mejor criterio del
    investigador.
    - Participantes con recidivas con evidencia documentada de progresión de más de 12 meses
    desde la finalización de la terapia endocrina (neo)adyuvante sin tratamiento para la
    enfermedad metastásica.
    - Participantes que hayan recibido tratamiento anterior con fulvestrant, cualquier inhibidor de fosfatidilinositol-3-quinasa (PI3K), de la molécula diana de la rapamicina en mamíferos (mTOR) o de la proteína quinasa B (AKT).

    En el protocolo se describen más criterios y detalles de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    - Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria
    - Supervivencia libre de progresión (SLP) evaluada por el Comité de revisión independiente ciego (BIRC) conforme a los RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy and safety analyses will be performed after observing approximately 162 PFS events per BIRC assessment
    Los análisis de eficacia y seguridad principales se realizarán después de observar aproximadamente 162 acontecimientos de PFS según la evaluación del BIRC
    E.5.2Secondary end point(s)
    - Overall survival
    - Overall response rate (ORR) with confirmed response, clinical benefit rate (CBR) with confirmed response, duration of response (DOR) with confirmed response, and time to response (TTR) based on BIRC assessment and RECIST v1.1
    - PFS based on BIRC assessment and using RECIST v1.1 criteria for participants by PIK3CA mutation status assessed in ctDNA at baseline
    - Incidence, type and severity of adverse events per CTCAE v4.03 criteria
    - Time to definitive deterioration of ECOG performance status from baseline
    - Time to definitive (10%) deterioration in the global health status/Quality of Life (QoL) and symptom scale scores of the EORTC QLQ-C30 Change from baseline in global health status/QoL and symptom scale scores of the EORTC QLQ-C30
    - Time from randomization to objective tumour progression on next line treatment or death from any cause (PFS2)
    - Supervivencia global (OS).
    - Tasa de respuesta global (ORR) con respuesta confirmada, la tasa de beneficio clínico (CBR) con respuesta confirmada, la duración de respuesta (DOR) con respuesta confirmada y el tiempo hasta la respuesta (TTR) según la evaluación del BIRC) y RECIST) v1.1.
    - SLP basada en la evaluación del BIRC y según los criterios RECIST v1.1 para participantes considerando el estado de mutación de PIK3CA evaluado en el ADNtc en la basal.
    - Incidencia, tipo y gravedad de los acontecimientos adversos según los criterios CTCAE v4.03.
    - Tiempo hasta el deterioro definitivo del estado funcional ECOG respecto a la basal.
    - Tiempo hasta el deterioro definitivo (10 %) en el estado de salud global/calidad de vida (QoL) y las puntuaciones de la escala de síntomas QLQ-C30 de la EORTC. Cambio respecto a la basal en el estado de salud global/QoL y puntuaciones de la escala de síntomas QLQ-C30 de la EORTC.
    - Tiempo desde la aleatorización hasta la progresión tumoral objetiva en la siguiente línea de tratamiento o la muerte por cualquier causa (SLP2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From the date of randomization to the date of death for the OS

    - From the date of randomization up to maximum duration of 60 months for the other secondary endpoints
    - Desde la fecha de aleatorización hasta la fecha de la muerte para la OS.

    - Desde la fecha de aleatorización hasta la duración máxima de 60 meses en las otras variables secundarias.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Belgium
    Bulgaria
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    United Kingdom
    Czechia
    Greece
    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 the overall study is defined as the time point when data collection will stop
    El fin del estudio general se define como el momento en el que finalizará la recogida de datos.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 165
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 285
    F.4.2.2In the whole clinical trial 305
    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)
    After discontinuing all study treatment, further treatment is left to the physician's discretion.
    Después de suspender el tratamiento del estudio, el tratamiento adicional queda a criterio del médico.
    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 Decision2022-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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