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    Summary
    EudraCT Number:2021-003477-61
    Sponsor's Protocol Code Number:20210098
    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:2022-02-10
    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 number2021-003477-61
    A.3Full title of the trial
    A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)
    Estudio de fase 1b/3 de bemarituzumab más quimioterapia y nivolumab frente a solo quimioterapia y nivolumab en sujetos con cáncer gástrico y de la unión gastroesofágica avanzado no tratado previamente con sobreexpresión de FGFR2b (FORTITUDE-102)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab Alone
    Bemarituzumab más quimioterapia y nivolumab frente a solo quimioterapia y nivolumab
    A.4.1Sponsor's protocol code number20210098
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona s/n, Edifici Sud, 7a planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08039
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936001860
    B.5.6E-mailinformacion.medica.es@amgen.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 nameBemarituzumab
    D.3.2Product code AMG 552
    D.3.4Pharmaceutical form 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 INNBEMARITUZUMAB
    D.3.9.2Current sponsor codeAMG 552
    D.3.9.4EV Substance CodeSUB195744
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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.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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression
    Cáncer gástrico y de la unión gastroesofágica avanzado y no tratado con sobreexpresión de FGFR2b
    E.1.1.1Medical condition in easily understood language
    Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression
    Cáncer gástrico y de la unión gastroesofágica avanzado y no tratado con sobreexpresión de FGFR2b
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084227
    E.1.2Term Gastroesophageal junction cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b – Safety Lead-In
    •To evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab

    Phase 3
    •To compare efficacy of bemarituzumab plus mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab asassessed by overall survival
    Fase 1b: fase preliminar de seguridad
    • Evaluar la seguridad y la tolerabilidad de bemarituzumab más mFOLFOX6 y nivolumab.

    Fase 3
    • Comparar la eficacia de bemarituzumab más mFOLFOX6 y nivolumab con la de placebo más mFOLFOX6 y nivolumab, evaluada mediante la supervivencia global.
    E.2.2Secondary objectives of the trial
    Phase 1b – Safety Lead-In
    •To evaluate preliminary anti-tumor activity of bemarituzumab plus mFOLFOX6 and nivolumab
    •To characterize the pharmacokinetic (PK) profile of bemarituzumab when administered with mFOLFOX6 and nivolumab
    •To characterize the immunogenicity of bemarituzumab

    Phase 3
    •To compare efficacy between the treatment arms as assessed by:
    -Progression free survival (PFS)
    -Objective response (OR)
    •To evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab compared to placbo plus mFOLFOX6 and nivolumab
    •To compare efficacy between the treatment arms as assessed by:
    -Duration of response (DOR)
    -Disease control
    •To assess subject-reported and quality of life (QoL) outcomes
    •To characterize the pharmacokinetic (PK) profile of bemarituzumab when administered with mFOLFOX6 and nivolumab
    •To characterize the immunogenicity of bemarituzumab
    Fase 1b: fase preliminar de seguridad
    • Evaluar la actividad antitumoral preliminar de bemarituzumab más mFOLFOX6 y nivolumab.
    • Caracterizar el perfil farmacocinético (FC) de bemarituzumab cuando se administra con mFOLFOX6 y nivolumab
    • Caracterizar la inmunogenicidad de bemarituzumab.

    Phase 3
    • Comparar la eficacia entre los grupos de tratamiento, evaluada mediante:
    - Supervivencia libre de progresión (SLP).
    - Respuesta objetiva (RO).
    • Evaluar la seguridad y la tolerabilidad de bemarituzumab más mFOLFOX6 y nivolumab en comparación con placebo más mFOLFOX6 y nivolumab.
    • Comparar la eficacia entre los grupos de tratamiento, evaluada mediante:
    - Duración de la respuesta (DR).
    - Control de la enfermedad.
    • Evaluar los resultados notificados por los sujetos y los resultados de calidad de vida (CdV).
    • Caracterizar el perfil farmacocinético (FC) de bemarituzumab cuando se administra con mFOLFOX6 y nivolumab.
    • Caracterizar la inmunogenicidad de bemarituzumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria Part 1:
    - Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    - Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
    - Participant must be a candidate to receive mFOLFOX6 and nivolumab
    - Adequate organ function as follows:
    Absolute neutrophil count ≥ 1.5 x 10^9/L
    Platelet count ≥ 100 x 10^9/L
    Hemoglobin ≥ 9 g/dl
    Aspartate aminotransaminase (AST) and Alanine
    aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x
    ULN if liver involvement). Total bilirubin <1.5 x ULN (or < 2 x ULN if
    liver involvement); with the exception of participants with Gilbert's
    disease)
    Calculated or measured creatinine clearance (CrCl) of ≥ 50
    mL/minute calculated using the formula of Cockcroft and Gault
    International Normalized Ratio (INR) or prothrombin time (PT) <
    1.5 × ULN except for participants receiving anticoagulation, who
    must be on a stable dose of anticoagulant therapy for 6 weeks prior
    to enrollment.

    Additional Inclusion Criteria Part 2:
    - No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant or neo-adjuvant therapy for localized disease is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment.
    - Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by centrally performed immunohistochemistry (IHC) testing
    -Adultos con adenocarcinoma gástrico o de la unión gastroesofágica documentado histológicamente, irresecable, localmente avanzada o metastásica (no susceptible de tratamiento curativo).
    -Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 a 1.
    -Enfermedad medible o no medible, pero evaluable, según los criterios RECIST v. 1.1.
    -El sujeto debe ser candidato para recibir mFOLFOX6 y nivolumab.
    -Función orgánica adecuada tal como se define a continuación:
    •Recuento absoluto de neutrófilos ≥ 1,5 x 109/l.
    •Recuento plaquetario ≥ 100 x 109/l.
    •Hemoglobina ≥ 9 g/dl.
    •Aspartato aminotransferasa (AST) y ALT < 3 x LSN (o < 5 x límite superior de la normalidad [LSN] si hay afectación hepática). Bilirrubina total < 1,5 x LSN (o < 2 x LSN si hay afectación hepática; salvo los sujetos con enfermedad de Gilbert).
    •Aclaramiento de creatinina (ClCr) calculado o medido de ≥ 50 ml/minuto determinado mediante la fórmula de Cockcroft y Gault ([140 − edad] x masa [kg]/[72 x creatinina mg/dl]).
    •INR o tiempo de protrombina (TP) < 1,5 x LSN, salvo en el caso de los sujetos que reciban tratamiento anticoagulante, que deben haber recibido una dosis estable de tratamiento anticoagulante durante las 6 semanas previas a la inclusión.
    Criterios de inclusión adicionales para la Parte 2:
    -No haber recibido tratamiento previo para la enfermedad metastásica o irresecable, salvo un máximo de 1 dosis de mFOLFOX6 con o sin nivolumab. Se permite el tratamiento adyuvante o neoadyuvante previo para tratar la enfermedad localizada, siempre que haya finalizado más de 6 meses antes de recibir la primera dosis del tratamiento del estudio.
    -Sobreexpresión del FGFR2b determinada mediante pruebas IHQ realizadas centralmente.
    E.4Principal exclusion criteria
    - Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
    - Known positive human epidermal growth factor receptor 2 (HER2) status
    - Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
    - Peripheral sensory neuropathy grade 2 or higher
    - Clinically significant cardiac disease
    - Other malignancy within the last 2 years (exceptions for definitively treated disease)
    - Chronic or systemic ophthalmologic disorders
    - Major surgery or other investigational study within 28 days prior to randomization
    - Palliative radiotherapy within 14 days prior to randomization
    - Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
    - Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study

    Please refer to protocol for remaining exclusion criteria
    -Tratamiento previo con cualquier inhibidor selectivo de la vía FGF-FGFR.
    -Estado positivo conocido del HER2
    -Metástasis en el SNC no tratadas o sintomáticas y enfermedad leptomeníngea
    -Neuropatía sensorial periférica de grado 2 o superior
    -Cardiopatía clínicamente significativa
    -Antecedentes de otros tumores malignos en los últimos 2 años (excepto para aquellos tratados definitivamente)
    -Trastornos oftalmológicos crónicos o sistémicos
    -Cirugía mayor o participación en otro estudio investigacional en los 28 días previos a la aleatorización
    -Radioterapia paliativa en los 14 días previos a la aleatorización
    -Anomalías conocidas de la córnea que puedan conllevar un mayor riesgo de desarrollar una úlcera corneal
    -Enfermedad autoinmunitaria activa que haya requerido tratamiento sistémico (salvo tratamiento sustitutivo) en los últimos 2 años o cualquier otra enfermedad que requiera tratamiento inmunosupresor durante el estudio

    Ver en el protocolo los demás critorios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b – Safety Lead-In
    •Dose limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, visual acuity, electrocardiogram (ECG), physical examinations, and clinical laboratory tests

    Phase 3
    •Overall survival, defined as time from randomization until death from any cause. Subjects still alive will be censored at the date last known to be alive
    Fase 1b: fase preliminar de seguridad
    •Toxicidades limitantes de la dosis (TLD), acontecimientos adversos aparecidos durante el tratamiento, acontecimientos adversos relacionados con el tratamiento y cambios clínicamente significativos en las constantes vitales, la agudeza visual, los electrocardiogramas (ECG), las exploraciones físicas y las pruebas analíticas clínicas.
    Fase 3
    •Supervivencia global, definida como el tiempo que transcurre desde la aleatorización hasta la muerte por cualquier causa. Los sujetos que aún sigan con vida serán censurados en la última fecha en que se sabe que estaban vivos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: throughout Phase 1b of the study
    OS: every 3 months (± 1 month) after the safety follow-up visit until 443 total deaths have been observed in the study or 15 months after the last subject is enrolled (whichever occurs later)
    Seguridad: a través de la fase 1b del estudio
    SG: cada 3 meses (± 1 mes) tras la visita de seguimiento de seguridad hasta que se hayan observado 443 muertes en total en el estudio o tras 15 meses del reclutamiento del último paciente del estudio (lo que ocurra más tarde)
    E.5.2Secondary end point(s)
    Phase 1b – Safety Lead-In
    •Objective response
    •Duration of response
    •Disease control (DCR)
    •Progression free survival (PFS)
    •Overall survival (OS)
    •PK parameters for bemarituzumab
    •Anti-bemarituzumab antibody formation

    Phase 3
    •PFS
    •Objective response
    •Treatment-emergent adverse events (including all adverse events, grade ≥ 3, serious adverse events, fatal adverse events, and adverse events requiring permanent discontinuation of investigational product)
    •Clinically significant changes in vital signs, visual acuity, and clinical laboratory tests
    •Duration of response
    •Disease control
    •Subjective score and change from baseline in following assessments:
    − EORTC Quality of Life Questionnaire Version 3.0(QLQ-C30) individual scores (raw and transformed) for the 5 functional scales, 9 symptom scales, global health status/quality of life scale and change from baseline at each assessment
    − Stomach cancer related symptoms measured by EORTC-QLQ-STO22
    − Summary scores at each assessment and changes from baseline of visual analogue scale (VAS) scores as measured by EuroQol 5-dimensional (EQ-5D-5L)
    − Time to deterioration in stomach-cancer related symptoms scores
    − Time to deterioration in health-related quality of life (HRQoL) scores
    − Time to deterioration in physical function scores
    •PK parameters for bemarituzumab
    •Anti-bemarituzumab antibody formation
    Fase 1b: fase preliminar de seguridad
    •Respuesta objetiva
    •Duración de la respuesta
    •Control de la enfermedad (TCE)
    •Supervivencia libre de progresión (SLP)
    •Supervivencia global (SG)
    •Parámetros FC de bemarituzumab
    •Formación de anticuerpos antibemarituzumab

    Fase 3
    •SLP
    •Respuesta objetiva
    •Acontecimientos adversos aparecidos durante el tratamiento (incluidos todos los acontecimientos adversos, los acontecimientos adversos de grado ≥ 3, los acontecimientos adversos graves, los acontecimientos adversos mortales y los acontecimientos adversos que requieran la interrupción permanente del tratamiento con el producto en investigación).
    •Cambios clínicamente significativos en las constantes vitales, la agudeza visual y las pruebas analíticas clínicas.
    •Duración de la respuesta
    •Control de la enfermedad
    •Puntuación subjetiva y cambio respecto al valor basal en las evaluaciones siguientes:
    -Puntuaciones individuales (brutas y transformadas) del cuestionario sobre calidad de vida (QLQ-C30), versión 3.0, de la EORTC para 5 escalas funcionales, 9 escalas de síntomas, escala de estado de salud/calidad de vida global y el cambio respecto al valor basal en cada evaluación.
    -Síntomas relacionados con el cáncer de estómago medidos por el cuestionario EORTC-QLQ-STO22.
    -Puntuaciones de resumen de cada evaluación y cambios respecto al valor basal de las puntuaciones de la escala visual analógica (EVA), medidas con el cuestionario EuroQoL de 5 dimensiones (EQ-5D-5L).
    -Tiempo hasta el deterioro de las puntuaciones de los síntomas relacionados con el cáncer de estómago.
    -Tiempo hasta el deterioro de las puntuaciones de la calidad de vida relacionada con la salud (CdVRS).
    -Tiempo hasta el deterioro de las puntuaciones de la función física.
    •Parámetros FC de bemarituzumab
    •Formación de anticuerpos antibemarituzumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS, ORR, DOR: Radiological/tumor assessment: Every 8 weeks until week 56 after cycle 1 day 1, then every 12 weeks;
    until start of new anticancer therapy, disease progression, death, withdrawal of consent, or end of study, whichever occurs first.
    TAEs: throughout study

    For other endpoints see Schedule of Activity (SoA)
    SLP, respuesta objetiva, duración de la respuesta: cada 8 semanas hasta la semana 56 tras el ciclo 1 día 1, y luego 12 semanas; hasta el comienzo

    Para otras variables ver Calendario de Actividad
    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 Yes
    E.6.13.1Other scope of the trial description
    to assess Tolerability, Immunogenicity, Biomarkers and Patient-reported Outcomes
    evaluar tolerabilidad, inmunogenicidad, biomarcadores y resultados reportados del paciente.
    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 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA146
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Colombia
    Czechia
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Poland
    Portugal
    Romania
    Russian Federation
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    United Kingdom
    United States
    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 date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long-term follow-up, additional antibody testing), as applicable.
    La fecha de finalización del estudio se define como la fecha en que se evalúa al último sujeto en todos los centros o recibe una intervención para su evaluación en el estudio (es decir, la última visita del último sujeto), incluidas las partes adicionales del estudio (e.j seguimiento a largo plazo, pruebas adicionales de anticuerpos), según corresponda.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 162
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 439
    F.4.2.2In the whole clinical trial 702
    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 Decision2022-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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