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    Summary
    EudraCT Number:2020-003272-41
    Sponsor's Protocol Code Number:R3918-MG-2018
    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:2021-09-28
    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 number2020-003272-41
    A.3Full title of the trial
    Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis
    Eficacia y seguridad del tratamiento combinado con pozelimab y cemdisirán en pacientes con miastenia grave generalizada sintomática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia Gravis
    Estudio para examinar la eficacia y seguridad del tratamiento combinado con pozelimab y cemdisirán en pacientes con miastenia grave generalizada sintomática
    A.4.1Sponsor's protocol code numberR3918-MG-2018
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 namePozelimab
    D.3.2Product code REGN3918
    D.3.4Pharmaceutical form 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 INNPozelimab
    D.3.9.2Current sponsor codeREGN3918
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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: 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 nameCemdisiran
    D.3.2Product code ALN-CC5
    D.3.4Pharmaceutical form 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 INNCemdisiran
    D.3.9.2Current sponsor codeALN-CC5
    D.3.9.4EV Substance CodeSUB217110
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Generalized Myasthenia Gravis
    Miastemia Grave Generalizada
    E.1.1.1Medical condition in easily understood language
    Generalized Myasthenia Gravis
    Miastemia Grave Generalizada
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous 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
    To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG)
    Evaluar el efecto de pozelimab + cemdisirán sobre la actividad diaria que se ve afectada por los signos y síntomas en pacientes con miastenia grave generalizada (MGg) sintomática
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of pozelimab + cemdisiran and cemdisiran monotherapy on:
    - Clinician-assessed signs of MG and muscle strength
    - Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only)
    - Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG
    - Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength
    - Health related quality of life
    - Proportion of patients with minimal MG symptoms
    - Patient- and clinician-reported signs and symptoms of MG
    • To evaluate the safety and tolerability of pozelimab + cemdisiran combination and cemdisiran monotherapy
    • To assess the concentrations of total pozelimab in serum
    • To assess the concentrations of cemdisiran and its metabolites in plasma
    • To assess the immunogenicity of pozelimab and of cemdisiran
    • To study the effect on complement activation following treatment
    Evaluar el efecto de pozelimab + cemdisirán y cemdisirán en monoterapia sobre:
    -Signos de miastenia grave y fuerza muscular
    -Actividad diaria que se ve afectada por los signos y síntomas de MGg sintomática (solo con cemdisirán en monoterapia)
    -Proporción de pacientes con mejoras en la actividad diaria que se ve afectada por los signos y síntomas de la MG
    -Proporción de pacientes que presentan mejoras en los signos de MG y en la fuerza muscular
    -Calidad de vida relacionada con la salud.
    -Proporción de pacientes con síntomas mínimos de MG.
    - Signos y síntomas de MG notificados por el paciente y por el médico.
    Analizar la seguridad y la tolerabilidad de la combinación de pozelimab + cemdisirán y cemdisirán en monoterapia.
    Evaluar las concentraciones de pozelimab total en suero.
    Evaluar las concentraciones de cemdisirán y sus metabolitos en plasma.
    Evaluar la inmunogenicidad de pozelimab y cemdisirán.
    Estudiar el efecto sobre la activación del complemento tras el tratamiento
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Future Biomedical Research (Optional)
    Patients who agree to participate in the FBR sub-study will be required to consent to this optional sub-study before samples are banked for FBR. Additional samples will be collected for FBR. The samples may be utilized for FBR that may or may not be directly related to the study, including being used as reference samples and assay development or validation.

    Pharmacogenomic Analysis (Optional)
    Patients who agree to participate in the genomics sub-study will be required to consent to this optional sub-study before collection of the samples. DNA and RNA samples will be collected for pharmacogenomics analyses to understand the genetic determinants of efficacy and safety associated with the treatments in this study and the molecular basis of MG and related diseases.
    Investigación biomédica futura (opcional)
    Los pacientes que estén de acuerdo en participar en el subestudio de la investigación biomédica futura (IBF) tendrán que dar su consentimiento para este subestudio opcional antes de que las muestras se almacenen para la IBF. Se recogerán muestras adicionales para la IBF. Las muestras podrían utilizarse para la IBF y podrían estar o no directamente relacionadas con el estudio, incluido su uso como muestras de referencia y como desarrollo o validación de análisis.

    Análisis farmacogenómico (opcional)
    Los pacientes que estén de acuerdo en participar en el subestudio genómico tendrán que dar su consentimiento para este subestudio opcional antes de la recogida de las muestras. Se recogerán muestras de ADN y ARN para los análisis farmacogenómicos con el objetivo de entender los determinantes genéticos de la eficacia y la seguridad asociados a los tratamientos de este estudio y la base molecular de la MG y las enfermedades relacionadas.
    E.3Principal inclusion criteria
    1. Male or female patients ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older)
    2. Patient with documented diagnosis of myasthenia gravis (MG) based on medical history and supported by previous evaluations as described in the protocol
    3. Documented prior history of positive serologic test or a positive result during screening of anti-acetylcholine receptor (AChR) antibodies or anti-LRP4 antibodies.
    4. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening
    5. Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score
    6. Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator
    7. Currently receiving an immunosuppressive therapy (IST) for MG, or documented reason why the patient is not taking an IST per investigator
    8. If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during double-blind treatment period (DBTP).

    NOTE: Other Inclusion Criteria apply
    1. Hombres y mujeres de ≥18 años de edad en la selección (o mayores de edad según la normativa local, la edad que sea mayor).
    2. Pacientes con diagnóstico documentado de miastenia grave (MG) según los antecedentes médicos y respaldado por evaluaciones previas, tal como se describe en el protocolo.
    3. Antecedentes previos documentados de prueba serológica positiva o un resultado positivo durante la selección de anticuerpos contra el receptor de acetilcolina (AChR) o anticuerpos anti-LRP4.
    4. Clasificación clínica de clase II a IV de la Fundación Americana de Miastenia Gravis (MGFA) en la selección.
    5. Puntuación ≥6 en la escala de actividades de la vida diaria de la miastenia grave (MG-ADL) en la selección. Los elementos oculares no deben contribuir más del 50 % de la puntuación total de MG-ADL.
    6. Recepción, en la actualidad, de un inhibidor de la acetilcolinesterasa o una razón documentada para no utilizar el tratamiento con inhibidores de la acetilcolinesterasa, según el investigador.
    7. Recepción, en la actualidad, de un tratamiento inmunodepresor (TID) para la MG o una razón documentada por la que el paciente no esté tomando un TID, según el investigador.
    8. Si actualmente se recibe un TID, no se prevé cambiar la dosis del TID antes de la aleatorización ni durante el periodo de tratamiento doble ciego (PTDC).

    NOTA: Se aplican otros criterios de inclusión.
    E.4Principal exclusion criteria
    1. Patients with a positive serologic test for antibodies to muscle specific tyrosine kinase (MuSK) during screening
    2. History of thymectomy within 12 months prior to screening or planned during the study
    3. History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
    4. Myasthenic crisis or Myasthenia Gravis Foundation of America (MGFA) Class V within 1 month of screening
    5. No documented meningococcal vaccination within 5 years prior to screening visit unless vaccination will be administered during the screening period and prior to initiation of study treatment
    6. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol
    7. Patients who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics
    8. Positive hepatitis B surface antigen or hepatitis C virus ribonucleic acid (RNA) during screening.
    9. History of HIV infection

    NOTE: Other Exclusion Criteria apply
    1. Pacientes con una prueba serológica positiva de anticuerpos contra la tirosina cinasa específica del músculo (MuSK) durante la selección.
    2. Pacientes con antecedentes de timectomía en los 12 meses anteriores a la selección o timectomía prevista durante el estudio.
    3. Pacientes con antecedentes de timoma maligno (puede inscribirse a pacientes en estadio 1) o con antecedentes de cáncer en los últimos 5 años, excepto carcinoma basocelular, carcinoma epidermoide o cáncer de cuello de útero in situ tratado adecuadamente.
    4. Pacientes con crisis miasténica o clase V según la Fundación Americana de Miastenia Gravis (MGFA) 1 mes antes de la selección.
    5. Pacientes sin vacunación meningocócica documentada en los 5 años anteriores a la visita de selección, a menos que la vacunación se administre durante el periodo de selección y antes del inicio del tratamiento del estudio.
    6. Pacientes con contraindicación conocida para las vacunas meningocócicas (grupo del conjugado ACWY y grupo B de vacunas) tal como se describe en el protocolo.
    7. Pacientes que requieran antibióticos para la profilaxis meningocócica y tengan una contraindicación, advertencia o precaución que impida el uso de antibióticos de la clase de la penicilina y antibióticos alternativos a la penicilina que se prevé usar como profilaxis, o antecedentes de intolerancia que provoque la interrupción de estos antibióticos.
    8. Pacientes con resultado positivo para el antígeno de superficie del virus de la hepatitis B o ácido ribonucleico (ARN) del virus de la hepatitis C durante la selección.
    9. Antecedentes de infección por VIH.

    NOTA: Se aplican otros criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score from baseline to week 24
    Cambio en la puntuación total de la escala de actividades de la vida diaria de la miastenia grave (MG-ADL) desde el inicio hasta la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    Desde el inicio hasta la semana 24
    E.5.2Secondary end point(s)
    1. Change from baseline in Quantitative Myasthenia Gravis (QMG) score at week 24
    2. Proportion of patients responding on the MG-ADL, with a responder defined as one with a ≥3-point improvement from baseline to week 24
    3. Proportion of patients responding on the QMG, with a responder defined as one with a ≥5-point improvement from baseline to week 24
    4. Proportion of patients with consistent response on the MG-ADL, defined as patients with at least a 2-point MG-ADL improvement on 2 or more consecutive assessments spanning 4 or more weeks during the DBTP
    5. Proportion of patients with minimal symptom expression (MSE, defined by a score of 0 to 1 on the MG-ADL) at week 24
    6. Change from baseline in the Myasthenia Gravis Composite (MGC) total score at week 24
    7. Change from baseline in Myasthenia Gravis Quality of Life (MG QOL15r) total score at week 24
    8. Proportion of patients with improvement point thresholds of ≥2, 4, 5, 6, 7, 8, 9, or 10 on MG-ADL at week 24
    9. Proportion of patients with improvement point thresholds of ≥3, 4, 6, 7, 8, 9, or 10 on QMG at week 24
    10. Incidence and severity of treatment-related adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) in patients treated with pozelimab + cemdisiran or placebo through week 24
    11. Concentrations of total pozelimab in serum at nominal time-points
    12. Concentrations of cemdisiran and its metabolites in plasma at nominal time points
    13. Incidence of treatment-emergent anti-drug antibodies (ADAs) to pozelimab after
    repeated doses over time
    14. Incidence of treatment-emergent ADAs to cemdisiran after repeated doses over time
    15. Change and percent change in CH50 over time
    1. Cambio en la puntuación total de la escala MG-ADL desde el inicio hasta la semana 24
    2. Proporción de pacientes con respuesta en la escala MG-ADL; un paciente con respuesta se define como un paciente con una mejora ≥3 puntos desde el inicio hasta la semana 24
    3. Proporción de pacientes con respuesta en la puntuación QMG; un paciente con respuesta se define como un paciente con una mejora ≥5 puntos desde el inicio hasta la semana 24
    4. Proporción de pacientes con respuesta uniforme en la escala MG-ADL, lo que se define como pacientes con una mejora de al menos 2 puntos en la escala MG-ADL durante 2 o más evaluaciones consecutivas habiendo transcurrido 4 o más semanas durante el PTDC
    5. • Proporción de pacientes con expresión mínima de los síntomas (EMS, definida por una puntuación de 0 a 1 en la escala MG-ADL) en la semana 24
    6. Cambio desde el inicio en la puntuación total de la escala compuesta de miastenia grave (MGC) hasta la semana 24
    7. Cambio desde el inicio en la puntuación total de la escala de calidad de vida de la miastenia grave de 15 ítems (MG QOL15r) hasta la semana 24
    8. Proporción de pacientes con umbrales de mejora de ≥2, 4, 5, 6, 7, 8, 9 o 10 puntos en la escala MG-ADL en la semana 24
    9. Proporción de pacientes con umbrales de mejora de ≥3, 4, 6, 7, 8, 9 o 10 puntos en la puntuación QMG en la semana 24
    10. Incidencia e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST), acontecimientos adversos graves (AAG) y acontecimientos adversos de especial interés (AAEI), en los pacientes tratados con pozelimab + cemdisirán o placebo, hasta la semana 24
    11. Concentraciones de pozelimab total en suero en puntos temporales indicados
    12. Concentraciones de cemdisirán y sus metabolitos en plasma en puntos temporales indicados
    13. Incidencia de ACF surgidos durante el tratamiento frente a pozelimab después de dosis repetidas a lo largo del tiempo
    14. Incidencia de ACF surgidos durante el tratamiento frente a cemdisirán después de dosis repetidas a lo largo del tiempo
    15. Cambio y variación porcentual en el ensayo de actividad hemolítica de la vía clásica (CH50) a lo largo del tiempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-10: Baseline to Week 24
    11-15: Though study duration, approximately 172 weeks
    1-10: desde el inicio hasta la semana 24.
    11-15: a pesar de la duración del estudio, 172 semanas.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Australia
    Canada
    Korea, Republic of
    Russian Federation
    Taiwan
    Ukraine
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Poland
    Spain
    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
    The end of study is defined as the date the last patient completes the last study visit, withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator).
    El fin del estudio se define como la fecha en que el último paciente completa la última visita del estudio, se retira del estudio o se pierde para el seguimiento (es decir, el investigador ya no puede ponerse en contacto con el paciente).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 210
    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 Decision2022-02-03
    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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