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    Summary
    EudraCT Number:2021-004811-26
    Sponsor's Protocol Code Number:ALK22/ENZ215-DEN2
    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:2022-02-02
    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 number2021-004811-26
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis
    Estudio de fase 3, aleatorizado, en doble ciego, de grupos paralelos y controlado con principio activo, para comparar la eficacia, seguridad, farmacodinamia, farmacocinética e inmunogenia de denosumab de Enzene (ENZ215) y Prolia® en mujeres posmenopáusicas con osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis
    Estudio de fase 3 para comparar denosumab de Enzene (ENZ215) y Prolia® en mujeres posmenopáusicas con osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    DANUBE
    DANUBE
    A.4.1Sponsor's protocol code numberALK22/ENZ215-DEN2
    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 SponsorAlkem Laboratories Limited
    B.1.3.4CountryIndia
    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 supportEnzene BioSciences Ltd.,
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlkem Laboratories Limited
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressSenapati Bapat Road, Lower Parel
    B.5.3.2Town/ cityMumbai
    B.5.3.3Post code400013
    B.5.3.4CountryIndia
    B.5.4Telephone number+91223989999
    B.5.6E-mailvinayaka.shahavi@alkem.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 nameEnzene Denosumab (ENZ215)
    D.3.2Product code ENZ215
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeENZ215
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 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 Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameEU licensed Prolia®
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal osteoporosis
    Osteoporosis posmenopáusica
    E.1.1.1Medical condition in easily understood language
    Osteoporosis in women after menopause
    Osteoporosis en mujeres después de la menopausia
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12
    - To compare the AUEC of sCTX levels from baseline to Month 6
    - Evaluar la eficacia de ENZ215 en comparación con Prolia® en pacientes con osteoporosis posmenopáusica, en términos de cambio en la densidad mineral ósea (bone mineral density, BMD) en la columna lumbar desde el momento basal hasta el mes 12
    - Comparar el área bajo la curva del efecto (area under the effect curve, AUEC) de las concentraciones de telopéptido carboxiterminal del colágeno de tipo 1 en suero (serum C telopeptide of Type 1 collagen, sCTX) desde el momento basal hasta el mes 6
    E.2.2Secondary objectives of the trial
    - To compare the change in sP1NP levels from baseline to Month 6
    - To compare the change in BMD at lumbar spine from baseline to Month 6
    - To compare the change in BMD at total hip and femoral neck from baseline to Month 6 and Month 12
    - To compare the immunogenicity potential of ENZ215 and Prolia®
    - To compare the safety and tolerability of ENZ215 and Prolia®
    - To compare the pharmacokinetics of ENZ215 and Prolia®
    - Comparar el cambio en las concentraciones de propéptido N-terminal del procolágeno de tipo 1 en suero (sP1NP) desde el momento basal hasta el mes 6
    - Comparar el cambio en la BMD en la columna lumbar desde el momento basal hasta el mes 6
    - Comparar el cambio en la BMD en la cadera total y el cuello femoral desde el momento basal hasta el mes 6 y el mes 12
    - Comparar la posible inmunogenia de ENZ215 y Prolia®
    - Comparar la seguridad y tolerabilidad de ENZ215 y Prolia®
    - Comparar la farmacocinética de ENZ215 y Prolia®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Postmenopausal women aged >/= 55 and </= 85 years
    2. Body weight >/= 50 kg and </= 90 kg
    3. Diagnosed with osteoporosis, with absolute BMD consistent with T-scores of </= -2.5 and >/= - 4.0 at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening
    4. At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening
    5. At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA
    1. Mujeres posmenopáusicas de edad >/= 55 y </= 85 años
    2. Con peso corporal >/= 50 kg y </= 90 kg
    3. Con diagnóstico de osteoporosis y una BMD absoluta acorde con puntuaciones T de </= -2,5 y >/= - 4,0 en la columna lumbar (región L1-L4), medida mediante absorciometría de rayos X de doble energía (DXA) en el momento de la selección
    4. Con al menos 5 años de posmenopausia confirmada por las concentraciones de hormona foliculoestimulante (FSH) en el momento de la selección
    5. Con al menos una articulación de la cadera y dos vértebras de la región L1-L4 evaluables mediante DXA
    E.4Principal exclusion criteria
    1.Previous exposure to Prolia® or any other denosumab biosimilar
    2.Previous use of oral bisphosphonates:
    a.Used for 3 or more years cumulatively
    b.If used for < 3 years, use within the past 12 months prior to screening
    3.Use of intravenous bisphosphonates within the past 5 years prior to screening
    4.Use of parathyroid hormone or its derivatives, systemic hormone replacement therapy, selective estrogen-receptor modulators, or tibolone or calcitonin within 12 months prior to enrollment
    5.Any prior use of fluoride or strontium
    6.Systemic glucocorticoids (>/=5 mg prednisone equivalent per day or cumulative dose >/=50 mg) for more than 10 days within 3 months prior to enrollment
    7.Other bone active drugs (i.e. drugs affecting bone metabolism) including heparin, anti epileptics (except for benzodiazepines and pregabalin), systemic ketoconazole, ACTH, lithium, protease inhibitors, GnRH agonists, or anabolic steroids within the past 3 months prior to screening
    8.History of one severe or more than two moderate vertebral fractures per Genant classification as determined by the central reading center
    9.History of hip fracture or bilateral hip replacement
    10.Total hip or femoral neck T-score <-4.0
    11.History and/or presence of atypical femoral fracture
    12.Presence of any active healing fracture according to the Investigator’s assessment
    13.History of any transplant or chronic immunosuppression
    14.Severe liver dysfunction ([ALT] or [AST] > 3 times upper limit of normal)
    15.Positive testing for hepatitis B ([HbsAg]) or hepatitis C ([HCV Ab]) virology
    16.Known history of human immunodeficiency virus (HIV) infection or positive serology for HIV at screening
    17.Significantly impaired renal function (determined by glomerular filtration rate of </=45 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) formula, as calculated by the central laboratory) or receiving dialysis
    18.Oral or dental conditions:
    a.Osteomyelitis or history and/or presence of osteonecrosis of the jaw (ONJ)
    b.Presence of risk factors for ONJ (e.g., periodontal disease, poorly fitting dentures, poor oral hygiene, invasive dental procedures such as tooth extractions within 6 months prior to screening)
    c.Active dental or jaw condition which requires oral surgery
    d.Planned invasive dental procedure
    19.Clinically significant leukopenia, neutropenia, or anemia as determined by the Investigator or any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with adherence to study procedures, study completion, or the interpretation of study results
    20.Patient with an active infection or history of infection as follows:
    a.Any active infection for which systemic anti-infectives were used within 4 weeks prior to screening
    b.A serious infection defined as requiring hospitalization or intravenous anti infectives within 8 weeks prior to screening
    c.Recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might compromise the safety of the patient
    Please refer to the protocol to see the rest of the exclusion criteria
    1.Exposición previa a Prolia® o a cualquier otro biosimilar de denosumab
    2.Uso previo de bisfosfonatos orales:
    a.Utilizados durante 3 o más años acumulados
    b.Utilizados durante menos de 3 años si se han administrado en los últimos 12 meses anteriores a la selección
    3.Uso de bisfosfonatos intravenosos en los últimos 5 años anteriores a la selección
    4.Uso de hormona paratiroidea o sus derivados, terapia de sustitución hormonal sistémica, moduladores selectivos de receptores de estrógenos, o tibolona o calcitonina en los 12 meses anteriores a la inclusión
    5.Cualquier uso previo de flúor o estroncio
    6.Uso de glucocorticoides sistémicos (>/=5 mg de equivalente de prednisona al día o dosis acumulada >/=50 mg) durante más de 10 días en los 3 meses anteriores a la inclusión
    7.Uso de otros fármacos con actividad ósea (es decir, fármacos que afectan al metabolismo óseo), como heparina, antiepilépticos (excepto benzodiacepinas y pregabalina), ketoconazol sistémico, hormona adrenocorticotrófica (ACTH), litio, inhibidores de la proteasa, agonistas de la hormona liberadora de gonadotropina (GnRH) o esteroides anabolizantes en los últimos 3 meses anteriores a la selección
    8.Antecedentes de una fractura vertebral grave o de más de dos fracturas moderadas según la clasificación de Genant, en su determinación por el evaluador central
    9.Antecedentes de fractura de cadera o prótesis de cadera bilateral
    10.Puntuación T total de la cadera o del cuello del fémur <4,0
    11.Antecedentes y/o presencia de fractura atípica de fémur
    12.Presencia de una fractura en fase de consolidación activa según el criterio del investigador
    13.Antecedentes de trasplante o inmunosupresión crónica
    14.Disfunción hepática grave ([ALT] o [AST] >3 veces el límite superior de la normalidad)
    15.Pruebas virológicas positivas de hepatitis B ([HbsAg]) o de hepatitis C ([HCV Ab])
    16.Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (HIV) o serología positiva para el HIV en el momento de la selección
    17.Insuficiencia renal significativa (determinada por una tasa de filtración glomerular </=45 ml/min/1,73 m2 por la fórmula del estudio de modificación de la dieta en la enfermedad renal [Modification of Diet in Renal Disease, MDRD], calculada por el laboratorio central) o en tratamiento con diálisis
    18.Afecciones orales o dentales:
    a.Osteomielitis o antecedentes y/o presencia de osteonecrosis de la mandíbula (osteonecrosis of the jaw, ONJ)
    b.Presencia de factores de riesgo de ONJ (por ejemplo, enfermedad periodontal, prótesis dentales mal ajustadas, mala higiene bucal, procedimientos dentales invasivos como extracciones dentarias en los 6 meses anteriores a la selección)
    c.Enfermedad dental o mandibular activa que requiera cirugía oral
    d.Procedimiento dental invasivo planificado
    19.Leucopenia, neutropenia o anemia clínicamente significativas, a juicio del investigador, o cualquier otra afección médica o anomalía de laboratorio clínicamente significativa que, en opinión del investigador, pueda suponer un riesgo para la seguridad de la paciente o dificultar el cumplimiento de los procedimientos del estudio, la finalización del mismo o la interpretación de sus resultados
    20.Paciente con infección activa o con antecedentes de infección como las siguientes:
    a.Infección activa para la que se hayan administrado antiinfecciosos sistémicos en las 4 semanas anteriores a la selección
    b.Infección grave, definida como aquella que requiere hospitalización o la administración de antiinfecciosos intravenosos, en las 8 semanas anteriores a la selección
    c.Infecciones recurrentes o crónicas u otra infección activa que, en opinión del investigador, pueda comprometer la seguridad de la paciente
    Por favor, referirse al protocolo para ver el resto de criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage change in BMD at lumbar spine (L1-L4 region) measured by DXA from baseline to Month 12
    - AUEC of sCTX over the initial 6 months (from Day 1 pre-dose to Month 6 pre dose)
    - Cambio porcentual en la BMD en la columna lumbar (región L1-L4) medido por absorciometría de rayos X de energía dual (dual energy X ray absorptiometry, DXA) desde el momento basal hasta el mes 12
    - AUEC de sCTX a lo largo de los primeros 6 meses (desde el día 1, antes de la administración, hasta el mes 6, antes de la administración)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    E.5.2Secondary end point(s)
    - Percentage change in sP1NP concentrations from baseline to Month 1, Month 3, and Month 6
    - Percentage change in BMD at lumbar spine measured by DXA from baseline to Month 6
    - Percentage change in BMD at total hip and femoral neck measured by DXA from baseline to Month 6 and Month 12
    - ADAs incidence at baseline (Day 1) and Months 1, 3, 6, 9, and 12 and during open label switch over period, i.e. Months 15 and 18
    - Treatment emergent serious and non serious adverse events (TEAEs) during main treatment period and open label switch over period
    - Alteration in clinical laboratory parameters during main treatment period and open-label switch over period
    - Serum concentrations (Cmax, Tmax, partial AUC(0-28), AUC(0 t), and AUC(0-inf)) of denosumab measured at baseline (Day 1), Day 8, Day 15, Month 1, Month 3, Month 6 (prior to second dose), and Month 12
    - Cambio porcentual en las concentraciones de sP1NP desde el momento basal hasta el mes 1, el mes 3 y el mes 6
    - Cambio porcentual en la BMD de la columna lumbar medido por DXA desde el momento basal hasta el mes 6
    - Cambio porcentual en la BMD de la cadera total y del cuello femoral medido por DXA desde el momento basal hasta el mes 6 y el mes 12
    - Presencia de anticuerpos antidenosumab (anti-denosumab antibodies, ADA) en el momento basal (día 1) y en los meses 1, 3, 6, 9 y 12 y durante el período abierto con cambio de tratamiento, es decir, en los meses 15 y 18
    - Efectos adversos surgidos durante el tratamiento (treatment emergent adverse event, TEAE), graves y no graves, en el período de tratamiento principal y el período abierto con cambio de tratamiento
    - Alteración de los parámetros de laboratorio durante el período de tratamiento principal y el período abierto con cambio de tratamiento
    - Concentraciones séricas (Cmax, Tmax, AUC parcial(0-28), AUC(0-t) y AUC(0-inf)) de denosumab medidas en el momento basal (día 1), día 8, día 15, mes 1, mes 3, mes 6 (antes de la segunda dosis) y mes 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Percentage change in sP1NP concentrations from baseline to Month 1, Month 3, and Month 6
    - Percentage change in BMD at lumbar spine measured by DXA from baseline to Month 6
    - Percentage change in BMD at total hip and femoral neck measured by DXA from baseline to Month 6 and Month 12
    - ADAs incidence at baseline (Day 1) and Months 1, 3, 6, 9, and 12 and during open label switch over period, i.e. Months 15 and 18
    - Serum concentrations (Cmax, Tmax, partial AUC(0-28), AUC(0 t), and AUC(0-inf)) of denosumab measured at baseline (Day 1), Day 8, Day 15, Month 1, Month 3, Month 6 (prior to second dose), and Month 12
    - Cambio porcentual en las concentraciones de sP1NP desde el momento basal hasta el mes 1, el mes 3 y el mes 6
    - Cambio porcentual en la BMD de la columna lumbar medido por DXA desde el momento basal hasta el mes 6
    - Cambio porcentual en la BMD de la cadera total y del cuello femoral medido por DXA desde el momento basal hasta el mes 6 y el mes 12
    - Presencia de anticuerpos antidenosumab (anti-denosumab antibodies, ADA) en el momento basal (día 1) y en los meses 1, 3, 6, 9 y 12 y durante el período abierto con cambio de tratamiento, es decir, en los meses 15 y 18
    - Concentraciones séricas (Cmax, Tmax, AUC parcial(0-28), AUC(0-t) y AUC(0-inf)) de denosumab medidas en el momento basal (día 1), día 8, día 15, mes 1, mes 3, mes 6 (antes de la segunda dosis) y mes 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenia
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Bulgaria
    Czechia
    Denmark
    Lithuania
    Poland
    Serbia
    Spain
    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 EOS is defined as the date of the last visit of the last patient in the study or last scheduled procedure shown in the schedule of activities (SoA) for the last patient in the study globally.
    El final del estudio se define como la fecha de la última visita del último paciente del estudio o del último procedimiento programado que aparece en el calendario de actividades (SoA) del último paciente del estudio a nivel mundial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 378
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 427
    F.4.2.2In the whole clinical trial 504
    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
    Ninguno
    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 Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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