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    Summary
    EudraCT Number:2017-001940-37
    Sponsor's Protocol Code Number:EFC15246
    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:2017-10-02
    Trial results View 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 number2017-001940-37
    A.3Full title of the trial
    Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines
    Estudio aleatorizado, abierto y multicéntrico para evaluar el beneficio clínico de isatuximab en combinación con carfilzomib (Kyprolis®) y dexametasona en comparación con carfilzomib con dexametasona en pacientes con mieloma múltiple recidivante y/o refractario que hayan recibido previamente de 1 a 3 lineas de tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational Clinical Study Comparing Isatuximab,Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
    Estudio clínico multinacional para comparar isatuximab en combinación con carfilzomib (Kyprolis®) y dexametasona con carfilzomib con dexametasona en pacientes con mieloma múltiple recidivante y/o refractario
    A.3.2Name or abbreviated title of the trial where available
    IKEMA
    IKEMA
    A.4.1Sponsor's protocol code numberEFC15246
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1195-5957
    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 & 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 & 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 nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@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/3/14/1268
    D.3 Description of the IMP
    D.3.1Product nameisatuximab
    D.3.2Product code SAR650984
    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 INNIsatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.3Other descriptive nameSAR650984
    D.3.9.4EV Substance CodeSUB119676
    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.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 Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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 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 INNCarfilzomib
    D.3.9.1CAS number 868540-17-4
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dexamethasone 3.3 mg/mL solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderhameln pharmaceuticals ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDexamethasone
    D.3.4Pharmaceutical form Solution for injection
    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 INNDexamethasone
    D.3.9.3Other descriptive nameDEXAMETHASONE BASE
    D.3.9.4EV Substance CodeSUB125563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.3
    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: 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 Dexamethason 4 mg JENAPHARM®
    D.2.1.1.2Name of the Marketing Authorisation holderJENAPHARM
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDexamethasone
    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 INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDEXAMETHASONE BASE
    D.3.9.4EV Substance CodeSUB125563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Plasma cell myeloma
    mieloma múltiple
    E.1.1.1Medical condition in easily understood language
    Plasma cell myeloma
    mieloma múltiple
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10035226
    E.1.2Term Plasma cell myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.
    Demostrar el beneficio de isatuximab en combinación con carfilzomib y dexametasona en la prolongación de la supervivencia sin progresión (SSP) en comparación con carfilzomib y dexametasona en pacientes con mieloma múltiple (MM) recidivante y/o refractario que hayan recibido previamente entre 1 y 3 líneas de tratamiento.
    E.2.2Secondary objectives of the trial
    -To evaluate the Overall Response Rate (ORR), rate of very good partial response(VGPR) or better and complete response (CR) rate in both arms using IMWG(International Myeloma Working Group) criteria.
    -To evaluate rate of CR with minimal residual disease(MRD) negativity in both arms using IMWG criteria.
    -To evaluate the Overall Survival (OS) in both arms.
    -To evaluate safety in both arms.
    -To evaluate duration of response(DOR) in both arms.
    -To evaluate the Time To Progression (TTP) in both arm.
    -To evaluate the Second Progression Free Survival (PFS2) in both arms.
    -To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
    -To evaluate the immunogenicity of isatuximab in isatuximab arm.
    -To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms.
    - Evaluar la tasa de respuesta global (TRG),tasa de muy buena respuesta parcial (MBRP) o superior y la tasa de respuesta completa (RC) en ambos grupos, utilizando los criterios del IMWG (International Myeloma Working Group)
    - Evaluar la tasa de RC con negatividad para enfermedad mínima residual (EMR) en ambos grupos (criterios IMWG)
    - Evaluar la supervivencia global (SG) en los dos grupos.
    - Evaluar la seguridad en los dos grupos.
    - Evaluar la duración de la respuesta (DR) en ambos grupos.
    - Evaluar el tiempo hasta la progresión (THP) en los dos grupos.
    - Evaluar la SSP2 en los dos grupos.
    - Determinar el perfil farmacocinético (FC) de isatuximab y de carfilzomib combinados.
    - Evaluar la inmunogenicidad de isatuximab en el grupo tratado con este fármaco.
    - Evaluar la calidad de vida relacionada con la salud (CVRS) general y específica para la enfermedad y el tratamiento, así como los cambios de la CVRS, la utilidad del estado de salud y el estado de salud en ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with multiple myeloma previously treated with prior 1 to 3 lines and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours).
    Pacientes con mieloma múltiple que haya recibido al menos 1 línea previa hasta un máximo de 3 líneas, con enfermedad medible mediante Proteína M en suero ≥0,5 g/dl medida mediante inmunoelectroforesis de proteínas séricas; y/o Proteína M en orina ≥200 mg/24 horas medida mediante inmunoelectroforesis de proteínas en orina.
    E.4Principal exclusion criteria
    -Patients previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
    -Patients with only free light measurable.
    -Patients less than 18 years old, patients with Eastern Cooperative Oncology Group performance status more than 2.
    -Patients with inadequate biological tests.
    -Patients with myocardial infarction, sever/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
    -Patients with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
    -Patients with known acquired immunodeficiency syndrome related illness or requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
    -Women of childbearing potential or male patient with women of childbearing potential who do not agree to use highly effective method of birth control.
    - Los pacientes previamente tratados previamente con carfilzomib, que nunca obtuvieron al menos una respuesta menor durante las terapias anteriores y / o la última terapia anterior completada dentro de los 14 últimos días.
    - Paciente con enfermedad medible únicamente a través de las cadenas ligeras libres
    - Paciente menor de 18 años, pacientes con Estado funcional (EF) según el ECOG (Eastern Cooperative Oncology Group [Grupo Oncológico Cooperativo de la Costa Este]) superior a 2.
    - Pacientes con pruebas biológicas inadecuadas.
    - Pacientes con cualquiera de las siguientes afecciones durante los 6 meses anteriores a la aleatorización: infarto de miocardio, angina de pecho grave/inestable, injerto de revascularización coronaria/periférica, insuficiencia cardíaca congestiva de clases III o IV según la New York Heart Association [Asociación Neoyorquina del Corazón], arritmias de grado ≥3, accidente cerebrovascular o accidente isquémico transitorio o Fracción de eyección ventricular izquierda <40 %.
    - Pacientes con cáncer previo a menos que estén libres de la enfermedad por más de 5 años o cáncer in situ después de un tratamiento curativo que hayan sido tratados adecuadamente.
    - Pacientes con enfermedades conocidas relacionadas con el síndrome de inmunodeficiencia adquirida (SIDA) o enfermedad por VIH conocida que requiera tratamiento antirretrovírico, o bien presentar infección activa por el virus de la hepatitis A, B o C.
    - Mujeres con capacidad de concebir (MCC) o participante de sexo masculino con una pareja de sexo femenino con capacidad de concebir que no estén protegidas por un método anticonceptivo de gran eficacia y/o que no acepten o no se les puedan realizar pruebas de embarazo.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Suvival (PFS): The length of time between treatment allocation and a patient lives with the disease but it does not get worse.
    Supervivencia Libre de Progresión (PFS): La duración del tiempo entre la asignación del tratamiento y que un paciente vive con la enfermedad pero no empeora.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to approximately 36 months
    Hasta aproximadamente 36 meses
    E.5.2Secondary end point(s)
    1) Overall Response Rate (ORR): The proportion of patients that have a response to their disease: stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR)
    2) Rate of VGPR or better: The proportion of patients with sCR, CR and VGPR
    3) CR rate: The proportion of patients with sCR and CR
    4) Rate of CR with MRD(Minimal Residual Disease) negativity: The proportion of patients ≥CR (sCR and CR) and for whom MRD assessed by sequencing is negative.
    5) Overall Survival (OS): The length of time from the treatment allocation for a disease that patients are still alive
    6) Time to Progression (TTP): How long the study treatment last before disease progression occurs
    7) Second Progression Free Survial (PFS2): The length of time between treatment allocation and second progression disease
    8) Duration of response (DOR): How long from the first response is observed until disease progression
    9) Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria(NCI- CTC) version 4.03 grading scaling: To evaluate how many adverse events occur while taking study treatment
    10) Patient-reported outcome measured with Quality of Life questionnaire : To evaluate change in your daily activites from screening
    11) Pharmacokinetics of isatuximab: To evaluate the plasma concentration of isatuximab
    12) Pharmacokinetics of carfilzomib: To evaluate the plasma concentration of carfilzomib in 12 patients
    13) Immunogenicity (ADA): To evaluate if presence of anti-drug antibodies against isatuximab
    1) Tasa de Respuesta Global (ORR): La proporción de pacientes que tienen una respuesta a su enfermedad: respuesta completa estricta (RCS), respuesta completa (CR), respuesta parcial muy buena (VGPR) o respuesta parcial
    2) Tasa de VGPR o mejor: La proporción de pacientes con RCS, CR y VGPR
    3) Tasa de CR: La proporción de pacientes con CRC y CR
    4) Tasa de CR con la negatividad de MRD (Residual Minimal Residual): La proporción de pacientes ≥CR (sCR y CR) y para quienes la MRD evaluada por secuenciación es negativa.
    5) Supervivencia general (SO): La duración de la asignación del tratamiento para una enfermedad que los pacientes siguen vivos
    6) Tiempo hasta la progresión (TTP): ¿Cuánto tiempo dura el tratamiento del estudio antes de que ocurra la progresión de la enfermedad
    7) Segunda supervivencia libre de progresión (PFS2): La duración del tiempo entre la asignación del tratamiento y la enfermedad de la segunda progresión
    8) Duración de la respuesta (DOR): ¿Cuánto tiempo se observa desde la primera respuesta hasta la progresión de la enfermedad
    9) Número de pacientes con eventos adversos según el Instituto Nacional del Cáncer - Criterios Comunes de Toxicidad (NCI-CTC) versión 4.03 escala de calificación: Para evaluar cuántos eventos adversos ocurren durante el tratamiento del estudio
    10) Resultado informado por el paciente medido con el cuestionario de calidad de vida: Para evaluar el cambio en sus actividades diarias desde la selección
    11) Farmacocinética del isatuximab: Para evaluar la concentración plasmática de isatuximab
    12) Farmacocinética de carfilzomib: Para evaluar la concentración plasmática de carfilzomib en 12 pacientes
    13) Inmunogenicidad (ADA): Para evaluar si la presencia de anticuerpos anti-fármacos contra isatuximab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2), 3), 4), 6), 7), 8) up to approximately 36 months
    5) up to approximately 72 months
    9) Up to 30 days after last study treatment administration
    10) Screening to 90 days after last study treatment administration
    11) up to approximately10 months
    12) up to 1 month
    13) Up to 13 months
    1), 2), 3), 4), 6), 7), 8) hasta aproximadamente 36 meses
    5) hasta aproximadamente 72 meses
    9) Hasta 30 días después de la última administración del tratamiento del estudio
    10) Desde la selección a 90 días después de la última administración del tratamiento del estudio
    11) hasta aproximadamente 10 meses
    12) hasta 1 mes
    13) Hasta 13 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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Brazil
    Canada
    Czech Republic
    France
    Greece
    Hungary
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Russian Federation
    Spain
    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
    Approximately 3 years after analysis of primary endpoint
    Aproximadamente 3 años después del análisis de la variable principal
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 300
    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 Decision2017-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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