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    Summary
    EudraCT Number:2019-002089-11
    Sponsor's Protocol Code Number:CMBG453B12301
    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:2020-02-28
    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 number2019-002089-11
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo de azacitidina con o sin MBG453 para el tratamiento de pacientes con síndrome mielodisplásico (SMD) de riesgo intermedio, alto o muy alto según el IPSS-R o con Leucemia Mielomonocítica Crónica de tipo 2 (LMMC-2).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS), or Chronic Myelomonocytic Leukemia-2 (CMML-2)
    Estudio de azacitidina con o sin MBG453 para el tratamiento de pacientes con síndrome mielodisplásico
    (SMD) de riesgo intermedio, alto o muy alto, o con Leucemia Mielomonocítica Crónica de tipo 2 (LMMC-2).
    A.4.1Sponsor's protocol code numberCMBG453B12301
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34933064464
    B.5.6E-maileecc.novartis@novartis.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.3.2Product code MBG453
    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 INNNot yet defined
    D.3.9.2Current sponsor codeMBG453
    D.3.9.3Other descriptive nameMBG453
    D.3.9.4EV Substance CodeSUB178459
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 injection/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
    adult subjects with intermediate, high or very high risk (per IPSS-R prognostic risk categories) myelodysplastic syndrome or with Chronic Myelomonocytic Leukemia - 2 (CMML-2)
    sujetos adultos con síndrome mielodisplásico (SMD) de riesgo intermedio, alto o muy alto según el IPSS-R o con Leucemia Mielomonocítica Crónica de tipo 2 (LMMC-2)
    E.1.1.1Medical condition in easily understood language
    intermediate, high or very high risk myelodysplastic syndrome or with Chronic Myelomonocytic Leukemia - 2
    síndrome mielodisplásico de riesgo intermedio, alto o muy alto o con Leucemia Mielomonocítica Crónica de tipo 2
    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 HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10009018
    E.1.2Term Chronic myelomonocytic leukaemia
    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 compare overall survival (OS) in the MBG453 plus azacitidine arm versus placebo plus azacitidine arm
    Comparar la supervivencia global (OS) en el grupo de MBG453 más azacitidina frente al grupo de placebo más azacitidina
    E.2.2Secondary objectives of the trial
    Key Secondary:
    1:compare time to definitive deterioration of fatigue in the MBG453 plus azacitidine arm versus placebo plus azacitidine arm
    2: compare RBC transfusion-free intervals in the MBG453 plus azacitidine arm vs placebo plus azacitidine arm
    3: compare improvement of fatigue in the MBG453 plus azacitidine arm vs placebo plus azacitidine arm
    4: compare improvement of physical functioning in the MBG453 plus azacitidine arm vs placebo plus azacitidine arm
    5: compare improvement of emotional functioning in the MBG453 plus azacitidine arm vs placebo plus azacitidine arm
    Other:
    •assess response rate in each treatment arm
    •assess PFS in each treatment arm
    •assess leukemia-free survival in each treatment arm
    •assess safety profile of MBG453 when given in combination with azacitidine
    •assess improvement in RBC/Platelets transfusion independence in each treatment arm
    •characterize the PK of MBG453
    ____
    Lack of space, Please refer to the Protocol
    Secundarios clave:
    1: comparar el tiempo hasta el deterioro definitivo de fatiga en el grupo de MBG453 más azacitidina frente al grupo de placebo más azacitidina.
    2: comparar los intervalos sin transfusión de concentrados de hematíes (RBC) en el grupo de MBG453 más azacitidina frente al grupo de placebo más azacitidina
    3: comparar la mejoría de la fatiga en el grupo de MBG453 más azacitidina frente al grupo de placebo más azacitidina
    4: comparar la mejoría del funcionamiento físico en el grupo de MBG453 más azacitidina frente al grupo de placebo más azacitidina
    5: comparar la mejoría del estado emocional en el grupo de MBG453 más azacitidina frente al grupo de placebo más azacitidina.
    Otros:
    •evaluar la tasa de respuesta en cada grupo de tratamiento
    •evaluar la Supervivencia Libre de Progresión (PFS) en cada grupo de tratamiento
    •caracterizar la farmacocinética de MBG453
    ____
    Falta de espacio, por favor refieran al Protocolo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Actigraphy substudy:
    Activity monitoring sensors (Actigraphy) will be used in the study to record daily physical activity and sleep quality and will be offered to a subset of subjects as an additional, optional assessment.
    Subestudio de actigrafía:
    En el estudio se utilizarán sensores de monitorización de la actividad (actígrafo) para registrar la actividad física diaria y la calidad del sueño que se ofrecerán a un subgrupo de sujetos como una evaluación adicional y opcional.
    E.3Principal inclusion criteria
    Key inclusion criteria:
    • Signed informed consent must be obtained prior to participation in the study
    • Age greater than or equal to 18 years at the date of signing the informed consent form (ICF)
    • Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) based on WHO 2016 classification (Arber et al 2016) by local investigator assessment with one of the following Prognostic Risk Categories, based on the revised International Prognostic Scoring System (IPSS-R):
    • Very high (> 6 points)
    • High (> 4.5 - less than or equal to 6 points)
    • Intermediate (> 3 - less than or equal to 4.5 points)
    Or
    Morphologically confirmed diagnosis of Chronic Myelomonocytic Leukemia -2 based on WHO 2016 classification (Arber et al 2016) by local investigator assessment with WBC < 13 x 10^9/L
    • Indication for azacitidine treatment according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
    • Not eligible for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
    • Not eligible for hematopoietic stem cell transplantation according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    Please refer to protocol for further details and any additional inclusion criteria.
    Criterios de inclusión clave:
    • Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio
    • Edad mayor o igual a 18 años en la fecha de firma del formulario de consentimiento informado (FCI).
    •Diagnóstico morfológico de síndrome mielodisplásico (SMD) basado en la clasificación de la OMS de 2016 (Arber et al., 2016) por evaluación local del investigador y con una de las siguientes categorías de riesgo del Índice Pronóstico Internacional revisado (IPSS-R):
    • Muy alto (>6 puntos).
    • Alto (>4,5 - menor o igual a 6 puntos).
    • Intermedio (>3 - menor or igual a 4,5 puntos)
    O
    Diagnóstico morfológico de leucemia mielomonocítica crónica de tipo 2 basado en la clasificación de la OMS de 2016 (Arber et al., 2016) por evaluación local del investigador con WBC < 13 x 10^9/L
    • Indicación para el tratamiento con azacitidina según el investigador, de acuerdo con la práctica clínica habitual local y las pautas del centro para las decisiones sobre el tratamiento.
    • No candidato para quimioterapia intensiva según el investigador, de acuerdo con la práctica clínica habitual local y las pautas del centro para las decisiones sobre el tratamiento.
    • No candidato para trasplante de progenitores hematopoyéticos (TPH) según el investigador, de acuerdo con la práctica clínica habitual local y las pautas del centro para las decisiones sobre el tratamiento.
    • Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2.
    Por favor, refieran al protocolo para más detalles y cualquier criterio de inclusión adicional.
    E.4Principal exclusion criteria
    Key exclusion criteria:
    • Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune checkpoint inhibitors (e.g, anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines is allowed except if the drug was administered within 4 months prior to randomization
    • Previous first-line treatment for intermediate, high, very high risk myelodysplastic syndromes (based on IPSS-R) or CMML-2 with any antineoplastic agents including for example chemotherapy, lenalidomide and hypomethylating agents (HMAs) such as decitabine or azacitidine. However, previous treatment with hydroxyurea or leukopheresis to reduce WBC count is allowed prior to randomization.
    • Investigational treatment received within 4 weeks prior to randomization. In case of a checkpoint inhibitor: a minimal interval of 4 months prior to randomization is necessary to allow randomization.
    • Subjects with Myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) with revised International Prognostic Scoring System (IPSS-R) <= 3
    • Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary acute myeloid leukemia, primary or secondary myelofibrosis based on WHO 2016 classification (Arber et al 2016)
    • Diagnosis of therapy related myeloid neoplasms based on WHO 2016 classification
    (Arber et al 2016)
    • History of organ or allogeneic hematopoietic stem cell transplant
    Please refer to protocol for further details and any additional exclusion criteria.
    Criterios de exclusión clave:
    • Exposición previa a terapia dirigida a TIM-3 en algún momento. Terapia previa con inhibidores de los puntos de control inmunitarios o checkpoints (p. ej., anti-CTLA4, anti-PD-1, anti-PD-L1 o anti-PD-L2); las vacunas contra el cáncer únicamente están permitidas excepto si el fármaco se ha administrado durante los 4 meses anteriores a la aleatorización.
    • Tratamiento previo de primera línea para síndromes mielodisplásicos de riesgo intermedio, alto o muy alto (según el IPSS-R) o LMMC-2 con cualquier fármaco antineoplásico incluyendo por ejemplo quimioterapia, lenalidomida y fármacos hipometilantes (HMA, por sus siglas en inglés)) como decitabina o azacitidina. Sin
    embargo, está permitido el tratamiento previo con hidroxiurea o leucoferesis antes de la aleatorización para reducir el recuento de glóbulos blancos (WBC)
    • Tratamiento en investigación recibido durante las 4 semanas anteriores a la aleatorización. En caso de un inhibidor de los puntos de control inmunitarios o checkpoints, es necesario un intervalo mínimo previo de 4 meses para poder realizar la aleatorización.
    • Pacientes con síndrome mielodisplásico (SMD) según la clasificación de la OMS de 2016 (Arber et al., 2016) con el Índice Pronóstico Internacional revisado (IPSS-R) <= 3.
    • Diagnóstico de leucemia mieloide aguda (LMA) incluyendo leucemia promielocítica aguda y leucemia mieloide aguda extramedular y mielofibrosis primaria o secundaria según la clasificación de la OMS de 2016 (Arber et al., 2016).
    •Diagnóstico de neoplasias mieloides relacionadas con la terapia según la clasificación de la OMS de 2016 (Arber et al., 2016).
    •Antecedentes de trasplante de un órgano o trasplante alogénico de progenitores hematopoyéticos (Alo-TPH).
    Por favor, refieran al protocolo para más detalles y cualquier criterio de exclusión adicional.
    E.5 End points
    E.5.1Primary end point(s)
    OS is the time from randomization until death due to any cause. If the subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before cut-off date).
    OS es el tiempo desde la aleatorización hasta el fallecimiento debido a cualquier causa. Si se desconoce que el sujeto haya fallecido, se censurará la OS en la última fecha que se sepa que el sujeto estaba vivo (en la fecha de corte o antes de esa fecha).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Estimated at 28 months and 33 months after first patient randomized and up to 5 years after the first patient randomized
    Se ha estimado en 28 y 33 meses después del primer paciente aleatorizado y hasta 5 años después del primer paciente aleatorizado.
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    1. Time from randomization to at least 3 points worsening from baseline in FACIT-fatigue scores with no subsequent improvement above this threshold or death due to any cause, whichever occurs first
    2. Cumulative time of intervals with no evidence of RBC transfusion for at least 8 weeks at any point after randomization
    3. Percent of subjects with at least 3 point confirmed improvement from baseline in FACIT-fatigue scores
    4. Percent of subjects with at least 10 point confirmed improvement from baseline in physical functioning using EORTC QLQ-C30
    5. Percent of subjects with at least 10 point confirmed improvement from baseline in emotional functioning using EORTC QLQ-C30
    Other endpoints:
    a) Percentage of CR/mCR/PR/HI according to IWG-MDS as per investigator assessment; Percentage of SD according to IWG-MDS as per investigator assessment
    b) Time from randomization to disease progression (including transformation to acute leukemia per WHO 2016 classification), relapse from complete remission (CR) according to IWG-MDS or death due to any cause, whichever occurs first, as per investigator assessment
    c) Time from randomization to >= 20% blasts in bone marrow/peripheral blood (per WHO 2016 classification) or diagnosis of extramedullary acute leukemia, or death due to any cause
    d) Incidence and severity of AEs and SAEs, changes in laboratory values and vital signs (per CTCAE version 5)
    e) Number and percent of transfusion dependent subjects at baseline who become RBC/platelets transfusion independent after randomization as per IWG-MDS criteria
    f) Serum concentrations and pharmacokinetic parameters for MBG453
    g) Anti-drug Antibody (ADA) prevalence at baseline and ADA incidence on-treatment
    h) Change from baseline in EQ-5D-5L scores and VAS scores over time; Change from baseline to C12D1 of Global Health Status/QoL scores using EORTC QLQ-C30
    Variables secundarias principales
    1. Tiempo desde la aleatorización hasta un empeoramiento de al menos 3 puntos respecto a la basal en la puntuación FACIT-fatiga sin ninguna mejora posterior por encima de este límite o el fallecimiento por cualquier motivo, aquello que ocurra primero.
    2. Tiempo acumulado de intervalos sin evidencia de transfusión de RBC durante al menos 8 semanas en cualquier momento después de la aleatorización.
    3. Porcentaje de sujetos con una mejoría confirmada de al menos 3 puntos respecto a la basal en la puntuación FACIT-fatiga.
    4. Porcentaje de sujetos con una mejoría confirmada de al menos 10 puntos respecto a la basal en el funcionamiento físico utilizando el QLQ-C30 de la EORTC.
    5. Porcentaje de sujetos con una mejoría confirmada de al menos 10 puntos respecto a la basal en el funcionamiento emocional utilizando el QLQ-C30 de la EORTC.
    Otras variables:
    a) Porcentaje de RC/RCm/RP/MH según los criterios de SMD del IWG y la evaluación del investigador; porcentaje de EE según los criterios de SMD del IWG y la evaluación del investigador.
    b) Tiempo desde la aleatorización hasta la progresión de la enfermedad (incluyendo la transformación a leucemia aguda según la clasificación de 2016 de la OMS), recidiva tras la remisión completa (RC) según los criterios de SMD del IWG o el fallecimiento por cualquier motivo, aquello que ocurra primero, según lo determinado por el investigador.
    c) Tiempo desde la aleatorización hasta >=20 % blastos en médula ósea/sangre periférica (según la clasificación de 2016 de la OMS) o diagnóstico de leucemia aguda extramedular o fallecimiento por cualquier motivo.
    d) Incidencia y gravedad de AA y AAG, cambios en los valores de laboratorio y las constantes vitales (según la versión 5 de los CTCAE).
    e) Número y porcentaje de sujetos dependientes de la transfusión en la basal que pasan a ser independientes de la transfusión de RBC/plaquetas después de la aleatorización según los criterios de SMD del IWG.
    f) Concentraciones en suero y parámetros de farmacocinética para MBG453.
    g) Prevalencia de anticuerpos contra el fármaco (ADA) en la basal e incidencia de ADA durante el tratamiento.
    h) Cambio respecto a la basal en las puntuaciones de EQ-5D-5L y EVA a lo largo del tiempo; cambio desde la basal hasta el C12D1 en el estado general de la salud/puntuaciones de QoL utilizando el QLQ-C30 de la EORTC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1&3 C3D1 & every 2 cycles, EOT & every 12wks. Estimated at 33mths & up to 5yrs after first patient (FP) rando. 2 Throughout trial. Est at 28 & 33mths and up to 5yrs after FP rando. 4&5 C3/C6/C9D1, after C15 every 3 cycles, EOT & every 12wks. Est at 33mths & up to 5yrs after FP rando.
    a/b/c C7/C13D1 & every 12 cycles up to 5yrs after FP rando. d AEs, throughout trial. Hematology, D1+D8 of each cycle until EOT & every 12wks. Chemistry, D1 of each cycle until C7 & C9 & every 2 cycles after until EOT. Vital signs, D1+D8 of each cycle until EOT. e Throughout trial up to 5yrs after FP rando. f/g PK & IG, D8 of each cycle until C6, C9, C12 & every 6 cycles after, EOT, 30 & 150 days after EOT. Soluble Tim-3, D8 of C1/C3/C6. h C3D1, after every 3 cycles, EOT & every 12wks. Analysis at C12D1.
    1 y 3 C3D1 y cada 2 ciclos, EOT y cada 12 sem. Estimado en 33 meses y hasta 5 añs después del primer paciente (PP) aleatorizado. 2 Durante todo el ensayo. Estimado en 28 y 33 meses y hasta 5 añs después del PP aleatorizado. 4 y 5 C3/C6/C9D1, después C15 cada 3 ciclos, EOT y cada 12 semanas. Estimado en 33 meses y hasta 5 años después del PP aleatorizado. a/b/c C7/C13D1 y cada 12 ciclos hasta 5 años después de PP aleatorizado d AA, durante todo el ensayo. Hematología, D1+D8 de cada ciclo hasta el EOT y cada 12 semanas. Bioquímica, D1 de cada ciclo hasta C7 y C9 y posteriormente cada 2 ciclos hasta el EOT. Constantes vitales, D1 + D8 de cada ciclo hasta el EOT.

    Por falta de espacio, para más información por favor refieran al protocolo del ensayo.
    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 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 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) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Chile
    China
    Colombia
    Czech Republic
    Finland
    France
    Germany
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Netherlands
    Oman
    Portugal
    Russian Federation
    Saudi Arabia
    Singapore
    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
    LVLS
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 113
    F.4.2.2In the whole clinical trial 500
    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)
    At the end of the study, every effort will be made, in alignment with local regulations, to continue provision of MBG453 outside this study through an alternative setting to subjects who are receiving treatment with MBG453 and in the opinion of the investigator are still deriving clinical benefit. Options for continued treatment with MBG453 may include access to commercially available drug, or managed access program, or a roll-over study.
    Al final del estudio, se hará todo lo posible, de acuerdo a la normativa y legislación española, para continuar la provisión de MBG453 fuera de este estudio a través de un entorno alternativo para aquellos sujetos que están recibiendo tratamiento con MBG453 y en opinión del investigador mantienen un beneficio clínico. Las opciones para continuar el tratamiento con MBG453 pueden incluir el acceso a la medicación comercial, o programa de acceso, o a un estudio roll over.
    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 Decision2020-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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