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    Summary
    EudraCT Number:2017-001431-39
    Sponsor's Protocol Code Number:TCD14906
    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:2018-04-16
    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 number2017-001431-39
    A.3Full title of the trial
    A Phase 1/2 study to evaluate safety, pharmacokinetics and efficacy of isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma
    Estudio fase 1/2 para evaluar la seguridad, farmacocinética y eficacia de isatuximab en combinación con cemiplimab en pacientes con mieloma múltiple en recaída/refractario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Isatuximab in Combination with Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
    Isatuximab en combinación con cemiplimab en pacientes con mieloma múltiple en recaída/refractario
    A.4.1Sponsor's protocol code numberTCD14906
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1189-4706
    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 & developpement
    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 & developpement
    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 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 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 namecemiplimab
    D.3.2Product code REGN2810
    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 INNcemiplimab
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB179369
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Cancer
    Cáncer
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cáncer
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To evaluate the safety and tolerability of the combination of Isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.

    -To compare the overall response of the combination of Isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria.
    - Determinar la seguridad y la tolerabilidad de la combinación de isatuximab (SAR650984) y cemiplimab (REGN2810).
    - Comparar la tasa de respuesta global de la combinación de isatuximab y cemiplimab frente a isatuximab en monoterapia en pacientes con mieloma múltiple en recidiva/refractario al tratamiento (MMRR) según los criterios del Grupo Internacional de Trabajo sobre el Mieloma (IMWG) (fase 2 solamente).
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR),
    time to response (TTR), progression free survival (PFS), and overall survival (OS).

    -To assess the pharmacokinetics (PK) of Isatuximab and cemiplimab when given in combination.

    -To assess the immunogenicity of isatuximab and cemiplimab when given in combination.
    - Determinar las siguientes mediciones de la eficacia (fase 2 solamente): Tasa de beneficio clínico, Duración de la respuesta (DR), Tiempo hasta la respuesta (THR), Supervivencia libre de progresión (SLP), Supervivencia global (SG).
    - Determinar el perfil farmacocinético de isatuximab y cemiplimab cuando se administran en combinación.
    - Evaluar la inmunogenicidad de isatuximab y cemiplimab cuando se administran en combinación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
    -> Serum M-protein ≥1 g/dL (≥0.5 g/dL in case of IgA disease),
    AND/OR
    -> Urine M-protein ≥200 mg/24 hours,
    OR
    -> In the absence of measurable m-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).

    - Patients must have received prior treatment with an IMiD (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment).

    - Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line)

    - Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).
    Los pacientes deben tener un diagnóstico conocido de mieloma múltiple con evidencias de enfermedad medible, según se define a continuación:
    - Proteína M en suero ≥1 g/dl (≥0,5 g/dl en el caso de enfermedad de la IgA),
    Y/O
    - Proteína M en orina ≥ 200 mg/24 horas,
    O
    - En ausencia de proteína M medible, cadena ligera libre de inmunoglobulina en suero: ≥10 mg/dl y una proporción anómala de cadenas ligeras libres κ/λ de inmunoglobulina en suero (<0,26 o
    >1,65).

    Los pacientes deben haber recibido tratamiento previo con un fármaco inmunomodulador (IMiD) (durante ≥2 ciclos o ≥2 meses de tratamiento) y un inhibidor del proteasoma (IP) (durante ≥2 ciclos o ≥2 meses de
    tratamiento).

    Los pacientes deben haber recibido al menos 3 líneas previas de tratamiento (Nota: El tratamiento de inducción y trasplante de células madre ± mantenimiento se considerarán como una línea).

    Los pacientes deben haber alcanzado una RM o mejor con cualquier tratamiento contra el mieloma (es decir, la enfermedad primaria refractaria al tratamiento no es apta).
    E.4Principal exclusion criteria
    - Prior exposure to isatuximab or participated clinical studies with isatuximab.
    - Prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
    - Evidence of other immune related disease /conditions.
    - History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
    - Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
    - Has allogenic haemopoietic stem cell (HSC) transplant.
    - Prior treatment with idelalisib (a PI3K inhibitor).
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
    - Poor bone marrow reserve.
    - Poor organ function.
    - Exposición previa a isatuximab o participación en estudios clínicos participados con isatuximab.
    - Exposición previa a cualquier agente (aprobado o en investigación) que bloquee la vía PD-1 / PD-L1.
    - Evidencia de otras enfermedades / afecciones relacionadas con el sistema inmune.
    - Antecedentes de neumonitis no infecciosa que ha requerido tratamiento con corticoesteroides, o neumonitis actual. Antecedentes de radioterapia torácica.
    - Haber recibido una vacuna con virus vivo en los 30 días previos al inicio del tratamiento programado. Está permitida la vacuna antigripal estacional que no contenga el virus vivo.
    - Haber recibido un trasplante de células madre hematopoyéticas (CMH) alogénico.
    - Tratamiento previo con idelalisib (un inhibidor de PI3K),
    - Estado funcional (EF) según el Grupo Oncológico Cooperativo de la Costa Este (ECOG) >2.
    - Poca reserva de médula ósea.
    - Función disminuida de algún órgano.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Dose Limiting Toxicities (DLTs)
    DLTs are following AEs in Cycle 1 unless due to disease progression or an obviously unrelated cause: Grade (G) 4 neutropenia >7 days; G 3 to 4 neutropenia with fever or documented infection; G 3 to 4 thrombocytopenia with bleeding requiring intervention; G 4 non hematological AE; G ≥2 uveitis; G 3 non-hematological AE >3 days despite supportive care (with defined exceptions); Delay in initiation of the 2nd cycle >14 days for related laboratory abnormalities/AEs

    2 - Adverse events (AEs) and changes in laboratory tests and vital signs
    Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 Grade scaling

    3 - Overall Response Rate (ORR)
    ORR is defined as the proportion of patients with complete response (CR) (including sCR [stringent complete response]), very good partial response (VGPR) and partial response (PR)
    1 - Toxicidades limitantes de la dosis (DLT)
    Los DLT están siguiendo los eventos adversos en el ciclo 1 a menos que se deba a una progresión de la enfermedad o una causa obviamente no relacionada: neutropenia de grado (G) 4> 7 días; G 3 a 4 neutropenia con fiebre o infección documentada; G 3 a 4 trombocitopenia con hemorragia que requiere intervención; G 4 AE no hematológico; G ≥2 uveitis; G 3 AE no hematológico> 3 días a pesar de la atención de apoyo (con excepciones definidas); Retraso en el inicio del segundo ciclo de más de 14 días para anormalidades de laboratorio relacionadas / acontecimientos adversos

    2 - Acontecimientos adversos (AE) y cambios en pruebas de laboratorio y signos vitales
    Número de pacientes con AE y cambios en las pruebas de laboratorio y los signos vitales según el Instituto Nacional del Cáncer - Criterios comunes de toxicidad (NCI-CTC) versión 4.03 Escalado de grado

    3 - Tasa de respuesta global (TRG)
    TRG: se define como la proporción de pacientes con respuesta completa (RC) (incluida la respuesta completa estricta [RCe]), la RPMB (muy buena respuesta parcial) y la RP (respuesta parcial) evaluadas por los investigadores mediante los criterios de respuesta del IMWG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - Up to 4 weeks
    2 - Up to 90 days following the last administration of study treatment for ongoing related AE, ongoing serious AE and new related AE until resolution or stabilization
    3 - Up to 6 months from last patient in for primary efficacy analysis, and up to 12 months from last patient in (LPI) for the final analysis
    1 - hasta 4 semanas
    2 - Hasta 90 días después de la última administración del tratamiento del estudio para AE relacionado en curso, AE grave en curso y nuevos AEs relacionados hasta la resolución o estabilización
    3 - Hasta 6 meses desde el último paciente para el análisis de eficacia primaria, y hasta 12 meses desde el último paciente incluido (LPI) para el análisis final.
    E.5.2Secondary end point(s)
    1 - Clinical Benefit Rate (CBR)
    CBR is defined as the proportion of patients with CR (including sCR), VGPR, PR and minimalresponse (MR)

    2 - Duration of Response (DOR)
    DOR is defined as the time from the date of the first response (≥PR) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever happens first

    3 - Time to Response (TTR)
    TTR is defined as time from first study treatment administration to first response (≥PR) that is subsequently confirmed

    4 - Progression Free Survival (PFS)
    PFS is defined as time from the first study treatment administration to the date of first documentation of progressive disease that is subsequently confirmed or the date of death from any cause

    5 - Overall Survival (OS)
    OS defined as the time from the first study treatment administration to death from any cause

    6 - Assessment of PK parameter: partial AUC
    AUC is area under the drug concentration versus time curve

    7 - Assessment of PK parameter: Cmax
    Cmax is maximum drug concentration observed

    8 - Antibodies to isatuximab
    Levels of anti isatuximab antibodies in plasma samples will be determined

    9 - Antibodies to cemiplimab
    Levels of anti cemiplimab antibodies in serum samples will be determined
    1 - Tasa de beneficio clínico (TBC)
    Se define como la proporción de pacientes con RC (incluida la respuesta completa estricta [RCe]), la RPMB y la RP
    2 - Duración de la respuesta (DR),
    DR se define como el tiempo desde la fecha de la primera respuesta (≥PR) que se confirma posteriormente hasta la fecha de la primera progresión confirmada de la enfermedad o la muerte, lo que ocurra primero
    3 - Tiempo hasta la respuesta (THR),
    THR se define como el tiempo desde la primera administración del tratamiento del estudio hasta la primera respuesta (≥PR) que posteriormente se confirma
    4 - Supervivencia libre de progresión (SLP)
    La SLP se define como el tiempo desde la primera administración del tratamiento del estudio hasta la fecha de la primera documentación de la enfermedad progresiva que se confirma posteriormente o la fecha de fallecimiento por cualquier causa.
    5 - Supervivencia global (SG)
    Se define como el tiempo desde la primera administración del tratamiento del estudio hasta la muerte por cualquier causa
    6 - Evaluación del parámetro PK: AUC parcial
    AUC es el área bajo la curva de concentración de fármaco versus tiempo
    7 - Evaluación del parámetro PK: Cmax
    Cmáx es la concentración máxima de fármaco observada
    8 - Anticuerpos contra isatuximab
    Se determinarán los niveles de anticuerpos anti isatuximab en muestras de plasma
    9 - Anticuerpos contra cemiplimab
    Se determinarán los niveles de anticuerpos anti cemiplimab en muestras de suero
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4: Up to 6 months from last patient in for primary efficacy analysis, and up to 12 months from LPI for the final analysis
    5: Up to 12 months from LPI for the final analysis
    6 and 7: Up to 4 weeks
    8 and 9: Up to 12 months from LPI for the final analysis
    1 a 4: hasta 6 meses desde el último paciente para el análisis de eficacia primaria, y hasta 12 meses a partir de LPI para el análisis final
    5: hasta 12 meses a partir de LPI para el análisis final
    6 y 7: hasta 4 semanas
    8 y 9: hasta 12 meses a partir de LPI para el análisis final
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    isatuximab in combination with cemiplimab
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Spain
    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
    LSLV
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days13
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 123
    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 Decision2018-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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