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    Summary
    EudraCT Number:2021-002320-20
    Sponsor's Protocol Code Number:EFC16158
    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:2021-11-19
    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 number2021-002320-20
    A.3Full title of the trial
    A randomized, open-label, parallel-group, 18-month Phase 3 study to evaluate the effect of venglustat compared with usual standard of care on left ventricular mass index in participants with Fabry disease and left ventricular hypertrophy
    Estudio de fase 3 aleatorizado, abierto, de grupos paralelos y 18 meses de duración para evaluar el efecto de venglustat sobre el índice de masa ventricular izquierda, en comparación con el estándar de tratamiento en pacientes con enfermedad de Fabry e hipertrofia ventricular izquierda.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of venglustat tablets on left ventricular mass index in male and female adult participants with Fabry disease
    Un estudio para evaluar el efecto de comprimidos de venglustat sobre el índice de masa ventricular izquierda en pacientes hombres y mujeres adultos con enfermedad de Fabry.
    A.4.1Sponsor's protocol code numberEFC16158
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1266-5068
    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 et développement
    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 et développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis, S.A
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493485 94 00
    B.5.6E-mailes-reg-estudiosclinicos@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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1310
    D.3 Description of the IMP
    D.3.1Product nameVenglustat
    D.3.2Product code SAR402671, GZ402671 or GZ/SAR402671
    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 INNVenglustat malate
    D.3.9.1CAS number 1629063-78-0
    D.3.9.2Current sponsor codeGZ402671
    D.3.9.3Other descriptive nameGZ/SAR402671
    D.3.9.4EV Substance CodeSUB166602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 Replagal
    D.2.1.1.2Name of the Marketing Authorisation holderShire Human Genetic Therapies AB
    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.3.4Pharmaceutical 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 INNAgalsidase alfa
    D.3.9.1CAS number 104138-64-9
    D.3.9.4EV Substance CodeSUB12456MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 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: 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.2.1.1.1Trade name Fabrazyme
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe B.V
    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.3.4Pharmaceutical form Powder for 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 INNAgalsidase beta
    D.3.9.1CAS number 104138-64-9
    D.3.9.4EV Substance CodeSUB12457MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 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 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: 4
    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 Galafold
    D.2.1.1.2Name of the Marketing Authorisation holderAmicus Therapeutics Europe 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/368
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMigalastat
    D.3.9.3Other descriptive nameMigalastat
    D.3.9.4EV Substance CodeSUB177094
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number123
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fabry’s disease
    Enfermedad de Fabry
    E.1.1.1Medical condition in easily understood language
    Fabry’s disease
    Enfermedad de Fabry
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level PT
    E.1.2Classification code 10016016
    E.1.2Term Fabry's disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To compare the effect of venglustat with standard of care Fabry therapies on left ventricular mass index over 18 months in participants with Fabry disease and left ventricular hypertrophy
    - Comparar el efecto de venglustat con los estándares de tratamiento para la enfermedad de Fabry sobre el índice de masa ventricular izquierda durante 18 meses en pacientes con enfermedad de Fabry e hipertrofia ventricular izquierda.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of venglustat on renal function
    - To evaluate the effect of venglustat versus standard therapy on measures of cardiac function and cardiac lipid storage
    - To assess the safety and tolerability of venglustat in participants with Fabry disease
    - To evaluate the PK of venglustat in participants with Fabry disease
    - Evaluar el efecto de venglustat sobre la función renal.
    - Evaluar el efecto de venglustat frente al tratamiento estándar en las medidas de la función cardíaca y el almacenamiento de lípidos cardíacos.
    - Evaluar la seguridad y tolerabilidad de venglustat en pacientes con enfermedad de Fabry.
    - Evaluar la FC de venglustat en pacientes con enfermedad de Fabry.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female participants aged 18 to 65 with previously confirmed diagnosis of Fabry disease and a history of clinical symptoms of Fabry disease.
    - Participants may be receiving treatment with agalsidase alfa, agalsidase beta, or migalastat, or may be untreated.
    - Left ventricular hypertrophy.
    - Contraception for male or female participants: not pregnant or breastfeeding; no sperm donating for male participant.
    - A signed informed consent must be provided prior to any study-related procedures.
    - Pacientes hombres y mujeres entre 18 y 65 años de edad, con un diagnóstico confirmado previamente de enfermedad de Fabry y antecedentes de síntomas clínicos de la enfermedad de Fabry.
    - Los pacientes pueden estar recibiendo tratamiento con agalsidasa alfa, agalsidasa beta o migalastat o pueden no estar tratados.
    - Hipertrofia ventricular izquierda.
    - Anticoncepción para pacientes masculinos o femeninos: no embarazadas ni en período de lactancia; sin donación de esperma para el paciente masculino.
    - Se debe proporcionar un consentimiento informado firmado antes de cualquier procedimiento relacionado con el estudio
    E.4Principal exclusion criteria
    - History of transient ischemic attack, stroke, myocardial infarction, heart failure, major cardiovascular surgery or kidney transplantation.
    - History of seizures currently requiring treatment.
    - Underlying medical condition that may cause or contribute to left ventricular hypertrophy.
    - Asymmetric hypertrophy by echocardiography at screening.
    - Advanced cardiac fibrosis, defined as significant late gadolinium enhancement beyond the basal inferolateral left ventricular wall on cardiac MRI.
    - History of ongoing clinically significant cardiac arrythmia, prior or ongoing treatment for the above.
    - Estimated glomerular filtration rate <60 mL/min/1.73m2.
    - Presence of severe depression as measured by Beck’s Depression Inventory (BDI)-II >28 and/or a history of an untreated, unstable major affective disorder within 1 year of the screening visit.
    - Patients with hepatitis C, HIV, or hepatitis B infection.
    - Positive SARS-CoV-2 virus test within 2 weeks of enrollment, or COVID-19 requiring hospitalization within 6 months of enrollment.
    - History of drug and/or alcohol abuse.
    - Moderate to severe hepatic impairment.
    - History of or active hepatobiliary disease.
    - Liver enzymes (alanine aminotransferase/aspartate aminotransferase) or total bilirubin >2 times the upper limit of normal.
    - Cortical cataract ≥one-quarter of the lens circumference (Grade cortical cataract [COR-2]) or a posterior subcapsular cataract ≥2 mm (Grade [posterior subcapsular cataract [PSC-2]) at the time of screening.
    - Chronic regimen of potentially cataractogenic medications.
    - Strong or moderate inducers or inhibitors of cytochrome P450 CYP3A4 per Food and Drug Administration (FDA) classification within 14 days or 5 half lives, whichever is longer, prior to randomization.
    - Antecedentes de accidente isquémico transitorio, accidente cerebrovascular, infarto de miocardio, insuficiencia cardíaca, cirugía cardiovascular mayor o trasplante de riñón.
    - Antecedentes de convulsiones que actualmente requieran tratamiento.
    - Afección médica subyacente que pueda provocar o contribuir a la hipertrofia ventricular izquierda.
    - Hipertrofia asimétrica observada mediante el ecocardiograma de la selección.
    - Fibrosis cardíaca avanzada, definida como un realce tardío significativo con gadolinio más allá de la pared ventricular izquierda inferolateral basal en la RM cardíaca de la selección.
    -Antecedentes de arritmia cardíaca clínicamente significativa en curso, tratamiento previo o en curso para lo anterior.
    - Tasa de filtración glomerular estimada <60 ml/min/1,73 m2.
    - Presencia de depresión grave con una puntuación >28 en el Inventario de Depresión de Beck (Beck’s Depression Inventory, BDI)-II y/o antecedentes de un trastorno afectivo mayor inestable y no tratado en el año anterior a la visita de selección.
    - Pacientes con infección por hepatitis C, VIH, o hepatitis B
    - Resultado positivo en la prueba del virus SARS-CoV-2 en las 2 semanas anteriores a la inclusión o COVID-19 que ha requerido hospitalización en los 6 meses anteriores a la inclusión.
    - Historial de abuso de drogas y / o alcohol
    - Insuficiencia hepática de moderada a grave.
    - Historia o enfermedad hepatobiliar activa.
    - Enzimas hepáticas (alanina aminotransferasa / aspartato aminotransferasa) o bilirrubina total> 2 veces el límite superior de lo normal.
    - Catarata cortical ≥ un cuarto de la circunferencia del cristalino (grado de catarata cortical [COR-2]) o una catarata subcapsular posterior ≥2 mm (grado [catarata subcapsular posterior [PSC-2]) en el momento de la selección.
    - Régimen crónico de medicamentos potencialmente cataractógenos.
    - Inductores o inhibidores potentes o moderados del citocromo P450 CYP3A según la clasificación de la Food and Drug Administration (FDA) en los 14 días o 5 semividas, lo que sea más largo, antes de la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Slope of left ventricular mass index as measured by cardiac magnetic resonance imaging (MRI) (central reading)
    Pendiente del índice de masa ventricular izquierda medida mediante RM cardíaca (lectura central).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to 18 months
    Desde el inicio hasta los 18 meses
    E.5.2Secondary end point(s)
    1/ Slope of estimated glomerular filtration rate (eGFR) as assessed by the chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation

    2/ Change in T1 relaxation time, measured by cardiac MRI (central reading)

    3/ Change in global longitudinal strain, measured by echocardiography (central reading)

    4/ Number of participants with adverse event (AE) and serious adverse event (SAE)

    5/ Change in the lens clarity by ophthalmological examination

    6/ Change in Beck Depression Inventory-II (BDI-II) score

    7/ Plasma venglustat concentrations at prespecified visits over the study duration
    1/ Pendiente de la TFGe evaluada mediante la ecuación de creatinina CKD-EPI.
    2/ Cambio en el tiempo de relajación en T1, medido mediante RM cardíaca (lectura central).
    3/ Cambio en la tensión longitudinal global, medida mediante ecocardiograma (lectura central).
    4/ Número de pacientes con acontecimientos adversos (AA) y Acontecimientos adversos graves (AAG).
    5/ Cambio en la transparencia del cristalino mediante exploración oftalmológica.
    6/ Cambio en la puntuación BDI-II.
    7/ Concentraciones plasmáticas de venglustat en visitas preespecificadas a lo largo de la duración del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 1/ to 7/: from baseline to 18 months
    De 1/ a 7/: Desde el inicio hasta los 18 meses.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    China
    Japan
    Korea, Republic of
    Taiwan
    Turkey
    United States
    Austria
    Denmark
    France
    Germany
    Italy
    Netherlands
    Norway
    Poland
    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
    LVLS
    La última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months52
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months52
    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: 110
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 110
    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
    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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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