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    Summary
    EudraCT Number:2018-004479-11
    Sponsor's Protocol Code Number:CMBG453B12201
    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:2019-04-12
    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 number2018-004479-11
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase II multi-center study of intravenous MBG453 added to hypomethylating agents in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria
    Estudio de fase II, multicéntrico, aleatorizado, controlado con placebo y doble
    ciego de MBG453 intravenoso en combinación con fármacos hipometilantes
    en pacientes adultos con síndrome mielodisplásico (SMD) de riesgo
    intermedio, alto o muy alto según los criterios del IPSS-R.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II efficacy and safety study of MBG453 in combination with hypomethylating agents in subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS).
    Estudio de fase II de la eficacia y seguridad de MBG453 en combinación con
    fármacos hipometilantes en pacientes con síndrome mielodisplásico (SMD) de
    riesgo intermedio, alto o muy alto según los criterios del IPSS-R
    A.4.1Sponsor's protocol code numberCMBG453B12201
    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 number34 93 3064464
    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 myelodysplastic syndrome (MDS) as per IPSS-R criteria
    Pacientes adultos con síndrome mielodisplásico de riesgo intermedio, alto o muy alto según las categorías del IPSS-R
    E.1.1.1Medical condition in easily understood language
    intermediate, high or very high risk myelodysplastic syndrome
    Síndrome mielodisplásico de riesgo intermedio, alto o muy alto
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine if MBG453 combined with standard HMA therapy improves complete remission in subjects with intermediate, high, or very high risk MDS
    - To determine if MBG453 combined with standard HMA therapy improves PFS in subjects with intermediate, high or very high risk MDS
    - Determinar si MBG453 en combinación con la terapia estándar con fármacos hipometilantes (HMA) mejora la remisión completa de los pacientes con riesgo intermedio, alto o muy alto de SMD.
    - Determinar si MBG453 en combinación con la terapia estándar con HMA mejora la SLPen pacientes con riesgo intermedio, alto o muy alto de SMD.
    E.2.2Secondary objectives of the trial
    - To assess Overall Survival in each treatment arm
    - To assess Leukemia-free survival in each treatment
    - To assess responses rate in each treatment arm
    - To assess duration of complete remission in each treatment arm
    - To assess time to complete remission in each treatment arm.
    - To assess the improvement in RBC/platelets transfusion independence in each treatment arm.
    - To assess the safety profile of MBG453 when given in combination with HMA
    - To characterize the pharmacokinetics of MBG453 when given in combination with HMA
    - To evaluate immunogenicity of MBG453 when given in combination of HMA
    - Evaluar la supervivencia global en cada grupo de tratamiento.
    - Evaluar la supervivencia libre de leucemia en cada tratamiento.
    - Evaluar la tasa de respuestas en cada grupo de tratamiento.
    - Evaluar la duración de la remisión completa en cada grupo de tratamiento.
    - Evaluar el tiempo hasta la remisión completa en cada grupo de tratamiento.
    - Evaluar la mejora en la independencia transfusional de RBC/plaquetas en cada grupo de tratamiento.
    - Evaluar el perfil de seguridad de MBG453 administrado en combinación con HMA.
    - Caracterizar la farmacocinética de MBG453 administrado en combinación con HMA.
    - Evaluar la inmunogenicidad de MBG453 administrado en combinación con HMA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study.
    2. Age >/= 18 years at the date of signing the informed consent form (ICF).
    3. Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R):
    • Very high (> 6 points)
    • High (> 4.5-6 points)
    • Intermediate (> 3-4.5 points): a subject determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >/= 5% bone marrow blast
    4. Not suitable for intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these).
    5. No planned hematopoietic stem-cell transplantation (HSCT).
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
    1. Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
    2. Edad >/=18 años en la fecha de firma del formulario de consentimiento informado (FCI).
    3. Diagnóstico morfológico confirmado de síndrome mielodisplásico (SMD) basado en la clasificación de 2016 de la OMS (Arber et al., 2016) con una de las siguientes categorías de riesgo del Índice Pronóstico Internacional (IPSS-R) evaluadas por el investigador
    - Muy alto (>6 puntos)
    - Alto (>4,5-6 puntos)
    - Intermedio (>3-4,5 puntos): un paciente que se considere que está en la categoría de riesgo intermedio únicamente podrá participar en caso de presentar un nivel de blastos en la médula ósea >/=5 %.
    4. No apto para quimioterapia intensiva según la evaluación del investigador de edad, comorbilidades, pautas locales y práctica del centro (algún criterio o todos ellos).
    5. Ninguna previsión de trasplante de precursores hematopoyéticos (TPH).
    6. Estado funcional del Grupo Cooperativo Oncológico del Este (ECOG) de 0, 1 o 2.
    E.4Principal exclusion criteria
    1. Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines are allowed only if the last dose of the drug was administered more than 4 months prior to randomization.
    2. Previous treatment for intermediate, high or very high risk myelodysplastic syndromes (based on IPSS-R) with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine . However, previous treatment is permitted with hydroxyurea or leukopheresis.
    3. History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, decitabine or MGB453) or monoclonal antibodies (mAbs) and/or their excipients.
    4. Current use or use within 14 days prior to randomization of systemic, steroid therapy (>10mg/day prednisone or equivalent) or any immunosuppressive therapy . Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment.
    5. Investigational treatment for MDS received within 4 weeks prior to randomization. In case of a checkpoint inhibitor: 4 months minimum prior to randomization interval is necessary to allow enrollment.
    6. Active autoimmune disease requiring systemic therapy (e.g. corticosteroids).
    7. Live vaccine administered within 30 days prior to randomization.
    1. Exposición previa a terapia dirigida a TIM-3 en algún momento. Terapia previa con inhibidores de puntos de control inmunitario (p. ej., anti-CTLA4, anti-PD-1, anti-PD-L1 o anti-PD-L2); las vacunas contra el cáncer únicamente están permitidas si la última dosis del fármaco se ha administrado más de 4 meses antes de la aleatorización.
    2. Tratamiento previo para síndromes mielodisplásicos de riesgo intermedio, alto o muy alto (según el IPSS-R) con quimioterapia u otros fármacos antineoplásicos incluida la lenalidomida y los HMA como la decitabina o la azacitidina. Sin embargo, se permite el tratamiento previo con hidroxiurea o leucoaféresis.
    3. Antecedentes de reacciones graves de hipersensibilidad a cualquier principio de los fármacos del estudio (azacitidina, decitabina o MGB453) o anticuerpos monoclonales (AM) o sus excipientes.
    4. Uso actual, o durante los 14 días anteriores a la aleatorización, de terapia sistémica con esteroides (>10 mg/día de prednisona o equivalente) o cualquier terapia inmunosupresora. Se permite el uso de esteroides tópicos, inhalados, nasales u oftalmológicos. Terapia de sustitución; se permite el uso de esteroides administrados en caso de transfusión, no se consideran una forma de tratamiento sistémico.
    5. Tratamiento en investigación para SMD recibido durante las 4 semanas anteriores a la aleatorización. En caso de un inhibidor de puntos de control inmunitario: es necesario un periodo mínimo de 4 meses antes de la aleatorización para permitir la inclusión.
    6. Enfermedad autoinmune activa que requiera terapia sistémica (p. ej., corticosteroides).
    7. Vacuna viva administrada durante los 30 días anteriores a la
    aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    - Complete remission(CR) rate according to International Working Group (IWG) for MDS (protocol section 8.3) as per investigator assessment (protocol section 12.4.1.1)
    - PFS is defined as time from randomization to disease progression (including transformation to leukemia per WHO 2016 classification), relapse from CR according to IWG-MDS (protocol section 8.3) or death due to any cause, whichever occurs first, as per investigator assessment (protocol section 12.4.1.2)
    - Remisión completa (RC) según el International Working Group (IWG) para el SMD (sección del protocolo 8.3) según la evaluación del investigador (sección del protocolo 12.4.1.1)
    - PFS se define como el tiempo desde la randomización hasta la progresión de la enfermedad (incluyendo la transformación a leucemia según la clasificación de 2016 de la OMS), recidiva a partir de RC según IWG-SMD (sección del protocolo 8.3) o muerte debida a ninguna causa, lo que ocurra primero, según la evaluación del investigador (sección del protocolo 12.4.1.2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response assessments based on bone marrow asssessments at C4D1, C7D1, C10D1, and C13D1 and hematology assessments at D1, D8 and D22 of each cycle until end of treatment. After C13D1, bone marrow assessments done every 6 cycles (C19D1, C25D1, etc.) and hematology assessments every 2 months. If clinically indicated done at any time during the study.
    CR rate analysis at 18 months after first patient randomized. PFS Interim analysis at 28 months and final analysis at the latest 4 years after the first patient randomized.
    Las evaluaciones de médula ósea se realizarán en la selección en C4D1, C7D1, C10D1 y C13D1 y las evaluaciones de hematología en D1, D8 y D22 de cada ciclo hasta el fin de tratamiento. Después de C13D1, las evaluaciones de médula ósea se realizarán cada 6 ciclos (C19D1, C25D1, etc.) y las evaluaciones de hematología cada 2 meses. Si está clínicamente indicado, en cualquier momento durante el estudio.
    El análisis de la tasa de RC a los 18 meses después del primer paciente aleatorizado. Análisis intermedio de SLP alos 28 meses y el análisis final como máximo 4 años después de que se haya aleatorizado el primer paciente .
    E.5.2Secondary end point(s)
    1. Overall survival: Time from randomization to death due to any cause
    2. Leukemia-free survival: Time from randomization to ≥ 20% myeloblasts in bone-marrow/peripheral blood (per WHO 2016 classification) or death due to any cause
    3. Percentage of CR/mCR/PR according to IWG-MDS as per investigator assessment
    4. Duration of CR: Time from the date of the first documented CR to the date of relapse from CR or death due to any cause, whichever occurs first
    5. Time from randomization to the first documented CR
    6. Number and percent of subjects who are transfusion independent (Section 8.3) after randomization as per IWG-MDS
    7. Incidence and severity of AEs and SAEs, changes in laboratory values and vital signs, incidence of notable ECG abnormalities
    8. Serum concentrations and pharmacokinetic parameters for MBG453
    9. Anti-drug Antibody (ADA) prevalence at baseline and ADA incidence on treatment
    1. Supervivencia global: Tiempo transcurrido desde la aleatorización hasta la muerte debido a cualquier causa
    2. Supervivencia libre de leucemia: Tiempo transcurrido desde la aleatorización hasta >/= 20% de meloblastos en médula ósea/ sangre periférica (según clasificación de 2016 de la OMS) o muerto por cualquier causa.
    3. Porcentage de RC/RCm/RP según el IWG-SMD evaluadas por el investigador.
    4. Duración del RC: Tiempo transcurrido desde la primera RC documentada hasta la fecha de recidiva desde la RC o muerte debida a cualquier causa, lo que ocurra primero.
    5. Tiempo transcurrido desde la aleatorización hasta la primera RC documentada
    6. Número y porcentaje de sujetos que son independientes de la transfusión (Sección 8.3) después de la aleatorización según IWG-MDS
    7. Incidencia y severidad de EA y SAE, cambios en los valores de laboratorio y signos vitales, incidencia de anomalías notables en el ECG
    8. Concentraciones séricas y parámetros farmacocinéticos para MBG453.
    9. Prevalencia de anticuerpos antimedicamento (ADA) en la visita basal e incidencia de ADA en el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 28 months after first patient randomized or at the latest 4 years after the first patient randomized
    2. Based on bone marrow asssessments at C4D1, C7D1, C10D1, and C13D1 and after C13D1, every 6 cycles (C19D1, C25D1, etc.) and if clinically indicated at any time during the study
    3., 4. and 5. Same timepoints as for the primary endpoints
    6. and 7. For AEs and transfusions throughout the trial. For laboratory values, vital signs and ECG at various points throughout the duration of the trial (see protocol for details)
    8. and 9. PK and IG at D8 of each cycle until cycle 6 (only PK at C2) and at day 8 of cycles 9, 12, 18 and 24, end of treatment, and after EOT. Soluble TIM-3 at Cycle 1 Day 1 and Day 8, at day 8 of cycles 3 and 6.
    1. A los 28 meses después del primer paciente aleatorizado o como máximo 4 años después de aleatorización del primer paciente.
    2. Basadas en las evaluaciones de médula ósea en C4D1, C7D1, C10D1 y C13D1 y despúes de C13D1, cada 6 ciclos (C19D1, C25D1, etc.) y si clínicamente indicado, en cualquier momento del estudio.
    3., 4. y 5. Mismos momentos de evaluación que primeras variables.
    6. y 7. Para EA y transfusiones a lo largo del ensayo. Para valores de laboratorio, los signos vitales y el ECG en varios puntos a lo largo de la duración del ensayo (ver protocolo para más detalles)
    Refiérase al protocolo para demás momentos de evaluación de esta variable secundaria.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Norway
    Spain
    Sweden
    Taiwan
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial 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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 120
    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)
    All treated subjects should have a safety follow-up call conducted 30 days after last administration of HMA or 150 days after last administration of MBG453/placebo, whichever is the latest.
    At end of study, every effort will be made in alignment with local regulations to continue provision of study treatment outside this study through an alternative setting to subjects who have not yet progressed as per investigator and who in the opinion of investigator are still deriving clinical benefit.
    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 Decision2019-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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