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    Summary
    EudraCT Number:2018-002211-10
    Sponsor's Protocol Code Number:GRASPA-TNBC-2018-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-17
    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 number2018-002211-10
    A.3Full title of the trial
    A Randomized Phase 2/3 Study of Eryaspase in Combination with Gemcitabine and Carboplatin Chemotherapy versus Chemotherapy Alone As First-Line Treatment in Patients with Metastatic or Locally Recurrent Triple-Negative Breast Cancer.
    Estudio de fase 2/3, aleatorizado, de Eryaspase en combinación con quimioterapia con gemcitabina y carboplatino frente a quimioterapia sola como tratamiento de primera línea en pacientes con metástasis o cáncer de mama localmente recurrente triple negativo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine whether the addition of eryaspase to gemcitabine and carboplatin will reduce the tumor burden and stabilizate the tumor progression.
    Estudio para determinar si al adicción de eryaspase junto con gemcitabina y carboplatino redudirá el borde el tumor y estabilizará la progresión del mismo.
    A.3.2Name or abbreviated title of the trial where available
    TRYbeCA-2 – TRial of erYaspase in Breast CAncer
    A.4.1Sponsor's protocol code numberGRASPA-TNBC-2018-02
    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 SponsorERYTECH Pharma
    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 supportERYTECH Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationERYTECH Pharma
    B.5.2Functional name of contact pointIman El-Hariry
    B.5.3 Address:
    B.5.3.1Street Address60 avenue Rockefeller
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69008
    B.5.3.4CountryFrance
    B.5.4Telephone number+34900834223
    B.5.5Fax number+33478755629
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEryaspase
    D.3.4Pharmaceutical form Dispersion 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 INNL-asparaginase encapsulated in red blood cells
    D.3.9.3Other descriptive nameL-ASPARAGINASE ENCAPSULATED IN RED BLODD CELLS
    D.3.9.4EV Substance CodeSUB181586
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Triple-Negative Breast Cancer
    Cáncer de mama triple negativo
    E.1.1.1Medical condition in easily understood language
    Triple-Negative Breast Cancer
    Cáncer de mama triple negativo
    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 10075566
    E.1.2Term Triple negative breast cancer
    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 determine whether the addition of eryaspase to gemcitabine and carboplatin improves the objective response rate (ORR) by modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by an independent radiological review (IRR) in firstline treatment of locally recurrent or metastatic triple-negative breast cancer (TNBC) compared with chemotherapy alone.
    Determinar si la adición de eryaspase a gemcitabina y carboplatino mejora la tasa de respuestas objetivas (TRO) conforme a los Criterios de evaluación de la respuesta en tumores sólidos modificados, versión 1.1 (RECIST 1.1), según lo determinado por una revisión radiológica independiente (RRI), en el tratamiento de primera línea de pacientes con cáncer de mama triplemente negativo (CMTN) localmente recurrente o metastásico en comparación con la quimioterapia sola.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    To compare the ORR between the two treatment arms as determined by the Investigator’s assessment; To compare the CBR between the two treatment arms; To compare the DoR between the two treatment arms; To compare progression-free survival (PFS) between the two treatment arms; To compare OS between the two treatment arms; To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone; To evaluate the change in F-18 fluorodeoxyglucose (FDG) tumor uptake as a predictor of clinical response following one cycle of treatment with eryaspase and chemotherapy; To determine the PK and pharmacodynamics of eryaspase; To assess the immunogenicity of eryaspase as determined by the induction of antiasparaginase antibodies and neutralizing antibodies; To evaluate the relationship of clinical outcome with relevant biomarkers and tumorspecific mutational changes present in tumor tissues and blood samples
    Comparar la TRO entre los dos grupos de tratamiento, según la evaluación del investigador; Comparar la TBC entre los dos grupos de tratamiento; Comparar la DR entre los dos grupos de tratamiento; Comparar la supervivencia libre de progresión entre los dos grupos de tratamiento; Comparar la SG entre los dos grupos de tratamiento; Evaluar la seguridad y la tolerabilidad de eryaspase en combinación con quimioterapia en comparación con la quimioterapia sola; Evaluar la variación de la captación tumoral de F-18 fluorodesoxiglucosa como factor predictivo de la respuesta clínica después de un ciclo de tratamiento con eryaspase y quimioterapia; Determinar la PK y FD de eryaspase; Evaluar la inmunogenicidad de eryaspase , según lo determinado por la inducción de anticuerpos antiasparraginasa y anticuerpos neutralizantes; Evaluar la relación de la evolución clínica con biomarcadores pertinentes y cambios mutacionales específicos del tumor presentes en tejidos tumorales y muestras de sangre.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for the study if all the following criteria are met:
    1. Female or male, 18 years of age or older.
    2. Histologically confirmed diagnosis of invasive breast cancer.
    3. Metastatic or locally recurrent inoperable breast cancer not previously treated with chemotherapy.
    4. Diagnosis of triple negative breast cancer, defined as the absence of expression of the following receptors in the primary and/or metastatic tumor tissue:
    - HER2 protein over-expression and/or gene amplification, defined as:
    a) fluorescent in situ hybridization (FISH)-negative: FISH ratio <2.2), or
    b) immunohistochemistry (IHC) 0-1+, or c) IHC 2+/3+ AND FISH-negative (FISH ratio <2.2) (1).
    - Estrogen receptor (ER), defined as <1% staining by IHC (2).
    - AND progesterone receptors (PgR), defined as <1% staining by IHC.
    5. Measurable lesion(s) per RECIST 1.1.
    6. Available archival or fresh tumor tissue. Formalin-fixed paraffin-embedded (FFPE) block is preferred, or a minimum of 10 unstained, consecutive FFPE slides of one archived block is required.
    7. Adequate performance status (PS) score (see Appendix 11.2):
    o Eastern Cooperative Oncology Group (ECOG) PS score of 0, or
    o ECOG PS score 1 and score ≥80 on Karnofsky Performance Status (KPS) scale.
    8. Life expectancy of >12 weeks according to the Investigator’s clinical judgment.
    9. Females of childbearing potential must have a negative pregnancy test at screening and an additional pregnancy test prior to first dose. Females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 6 months after the last dose of study treatment.
    10. Adequate laboratory parameters at baseline (obtained <14 days prior to randomization):
    - Absolute neutrophil count ≥1.5 x 109/L.
    - Hemoglobin ≥9 g/dL.
    - Platelet count ≥100,000/mm3 (100 x 109/L).
    - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
    ≤2.5 x upper limit of normal (ULN) (≤5 x ULN in presence of liver metastases).
    - Total bilirubin ≤ 1.5 x institutional ULN.
    - Serum creatinine within normal limits or calculated clearance >60 mL/min/1.73 m2 for patients with serum creatinine levels above or below the institutional normal range. Actual body weight should be used for calculating creatinine clearance (e.g., using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) >30 Kg/m2, lean body weight should be used instead.
    - Acceptable coagulation parameters: plasma antithrombin III >70%, fibrinogen ≥1.5 g/dL, international normalized ratio (INR) <1.5, and partial thromboplastin time (PTT) ≤ institutional ULN.
    - Serum albumin ≥3.0 g/dL.
    11. Patients must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.
    Podrán participar en este estudio los pacientes que cumplan todos los criterios siguientes:
    1.Mujer o varón de 18 años o más de edad.
    2.Diagnóstico confirmado histológicamente de cáncer de mama invasivo.
    3.Cáncer de mama inoperable metastásico o localmente recurrente no tratado previamente con quimioterapia
    4.Diagnóstico de cáncer de mama triplemente negativo, definido como la ausencia de expresión de los siguientes receptores en el tejido tumoral primario o metastásico:
    Hiperexpresión de proteína HER2 o amplificación génica, definida como:
    a)hibridación in situ con fluorescencia (FISH) negativa: cociente FISH < 2,2, o
    b)inmunohistoquímica (IHQ) 0-1+, o c)IHQ 2+/3+ Y FISH negativa (cociente FISH < 2,2) (1).
    Receptores estrogénicos (RE), definido como una tinción < 1% mediante IHQ (2).
    Y receptores de progesterona (RPg), definido como una tinción < 1% mediante IHQ.
    5.Lesiones mensurables según los criterios RECIST 1.1
    6.Disponibilidad de tejido tumoral de archivo o reciente. Se prefiere un bloque fijado en formol e incluido en parafina (FFIP) o un mínimo de 10 extensiones FFIP consecutivas sin teñir de un bloque archivado.
    7.Puntuación de estado funcional (EF) adecuada (véase el apéndice 11.2):
    Puntuación de EF del Eastern Cooperative Oncology Group (ECOG) de 0, o
    Puntuación de EF del ECOG de 1 y puntuación ≥ 80 en la escala de estado funcional de Karnofsky (KPS).
    8.Esperanza de vida superior a 12 semanas según el criterio clínico del investigador.
    9.Las mujeres en edad fértil deberán tener una prueba de embarazo negativa en la fase de selección y otra antes de recibir la primera dosis. Las mujeres en edad fértil deberán comprometerse a utilizar un método anticonceptivo muy eficaz durante el tratamiento y hasta al menos seis meses después de recibir la última dosis del tratamiento del estudio.
    10.Parámetros analíticos adecuados en el momento basal (obtenidos < 14 días antes de la aleatorización):
    Recuento absoluto de neutrófilos ≥ 1,5 x 109/l.
    Hemoglobina ≥ 9 g/dl.
    Recuento de plaquetas ≥ 100.000/mm3 (100 x 109/l).
    Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 2,5 veces el límite superior de la normalidad (LSN) (≤ 5 veces el LSN en presencia de metástasis hepáticas).
    Bilirrubina total ≤ 1,5 veces el LSN del centro.
    Creatinina sérica dentro de los límites normales o aclaramiento calculado > 60 ml/min/1,73 m2 en los pacientes con concentraciones séricas de creatinina por encima o por debajo del intervalo normal del centro. Se utilizará el peso corporal real para calcular el aclaramiento de creatinina (por ejemplo, con la fórmula de Cockcroft-Gault). En los pacientes con un índice de masa corporal (IMC) > 30 kg/m2 deberá utilizarse en su lugar el peso corporal magro.
    Parámetros de coagulación aceptables: antitrombina plasmática III > 70%, fibrinógeno ≥ 1,5 g/dl, cociente internacional normalizado (INR) < 1,5 y tiempo de tromboplastina parcial (TTP) ≤ LSN del centro.
    Albúmina sérica ≥ 3,0 g/dl.
    11.Capacidad de comprender y cumplir las condiciones del protocolo, así como haber leído y comprendido el documento de consentimiento y otorgado el consentimiento informado por escrito
    E.4Principal exclusion criteria
    A patient is not eligible to participate in the study if any of the following criteria are met:
    1. Pregnant or lactating females.
    2. Original primary tumor or subsequent relapse known to be positive for ER, PgR, or HER2 receptors, as defined above.
    3. Confirmed BRCA1 or BRCA2 mutation carrier.
    4. Prior systemic therapy for metastatic or locally recurrent breast cancer.
    5. Bone as the only site of disease.
    6. Presence of untreated symptomatic central nervous system (CNS) metastases as determined by MRI or CT scan performed during screening.
    7. Prior radiotherapy to the only area of measurable disease.
    8. Prophylactic use of supportive bone-modifying therapy for skeletal-related events (e.g., bisphosphonate, pamidronate, or denosumab), unless treatment is initiated prior to or within 7 days after randomization.
    9. History of recent clinical pancreatitis, according to revised Atlanta criteria, within 3 months of randomization.
    10. Neurosensory neuropathy >Grade 2 at baseline.
    11. Known history of infection with human immunodeficiency virus (HIV) and/or active infection with hepatitis B or hepatitis C.
    12. Known hypersensitivity to gemcitabine, platinum compounds, mannitol, or asparaginase.
    13. Treatment with warfarin. Warfarin must be replaced with low-molecular weight heparin.
    14. History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >5 years.
    15. Any other severe acute or chronic condition that may increase the risk of study participation, including:
    - Current or history within 6 months prior to randomization of medically significant cardiovascular disease including symptomatic congestive heart failure >New York Heart Association (NYHA) Class II, unstable angina pectoris, clinically significant cardiac arrhythmia.
    - Psychiatric illness/social situations or any other serious uncontrolled medical disorders that in the opinion of the Investigator would limit compliance with study requirements.
    16. Receiving therapy in a concurrent clinical study. Patients must agree not to participate in any other interventional clinical studies during their participation in this trial while on study treatment. Patients taking part in surveys or observational studies are eligible to participate in this study.
    No podrán participar en el estudio los pacientes que cumplan alguno de los criterios siguientes:
    1.Mujer embarazada o en período de lactancia.
    2.Tumor primario original o recidiva posterior con positividad conocida para RE, RPg o HER2, según la definición anterior.
    3.Portador confirmado de una mutación de BRCA1 o BRCA2.
    4.Tratamiento sistémico previo contra el cáncer de mama metastásico o localmente recurrente.
    5.Hueso como único foco de enfermedad metastásica.
    6.Presencia de metástasis sintomáticas en el sistema nervioso central (SNC) no tratadas, determinado mediante RM o TC realizada durante la fase de selección.
    7.Radioterapia previa en la única zona de enfermedad mensurable.
    8.Uso profiláctico de tratamiento osteomodificador de apoyo por episodios óseos (p. ej., bisfosfonato, pamidronato o denosumab), a menos que el tratamiento se inicie antes de la aleatorización o en los 7 días siguientes a la misma.
    9.Antecedentes de pancreatitis clínica reciente, según los criterios de Atlanta revisados, en los tres meses previos a la aleatorización.
    10.Neuropatía neurosensorial de grado > 2 en el momento basal.
    11.Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o infección activa por el virus de la hepatitis B o C.
    12.Hipersensibilidad conocida a gemcitabina, compuestos derivados del platino, manitol o asparraginasa.
    13.Tratamiento con warfarina. La warfarina deberá sustituirse por una heparina de bajo peso molecular.
    14.Antecedentes de otras neoplasias malignas, excepto cáncer de piel distinto del melanoma debidamente tratado, cáncer in situ de cuello uterino tratado con intención curativa u otros tumores sólidos tratados con intención curativa sin signos de enfermedad durante más de cinco años.
    15.Cualquier otra enfermedad aguda o crónica grave que pueda aumentar el riesgo de la participación en el estudio, por ejemplo:
    Presencia o antecedentes en los seis meses previos a la aleatorización de una enfermedad cardiovascular médicamente significativa, como insuficiencia cardíaca congestiva sintomática en clase > II de la New York Heart Association (NYHA), angina de pecho inestable o arritmia cardíaca clínicamente significativa.
    Enfermedad psiquiátrica, situaciones sociales o cualquier otro trastorno médico grave no controlado que, en opinión del investigador, pueda limitar el cumplimiento de los requisitos del estudio.
    16.Recepción de tratamiento en un estudio clínico concurrente. Los pacientes deberán comprometerse a no participar en ningún otro estudio clínico intervencionista durante su participación en este ensayo mientras reciban el tratamiento del estudio. En este estudio podrán participar pacientes que estén participando en encuestas o estudios observacionales
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is ORR in evaluable patients, assessed by independent radiological review.
    El objetivo primario es la tasa de respuestas objetivas (TRO) de los pacientes evaluables, mediante evaluación radiológica independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will be based on Fisher’s combination test in light of the adaptive nature of the design for Part 1 and the sample size re-estimation. The onesided p-value for the Part 1 data prior to the sample size review (p1) will be combined with the p-value for the Part 1 data following the sample size review (p2) to give a one-sided p-value for the full Part 1 data. Statistical significance at the one-sided 10% level will be used to evaluate this p-value.
    In light of the small sample size for Part 1, the one-sided p-values p1 and p2 will be obtained using the stratified version of Fisher’s Exact test with stratification defined by the factors used for randomization.
    El análisis final se basará en la prueba de combinación de Fisher a la luz de la naturaleza adaptativa del diseño para la Parte 1 (P1) y la reestimación del tamaño de la muestra. El valor p unilateral para los datos de la P1 antes de la revisión del tamaño de la muestra (p1) se combinará con el valor p para los datos de la P1 después de la revisión del tamaño de la muestra (p2) para obtener un valor p unilateral para los datos completos de la P1. La significación estadística en el nivel de 10% unilateral se utilizará para evaluar este valor p. A la luz del tamaño de muestra pequeño para la P1, los valores de p de una cara p1 y p2 se obtendrán utilizando la versión estratificada de la prueba exacta de Fisher con la estratificación definida por los factores utilizados para la aleatorización.
    E.5.2Secondary end point(s)
    To evaluate PFS, measured as the interval from randomization until objective tumor progression or death from any cause, whichever occurs first.
    To evaluate BOR recorded from start of treatment until the EoT and will be determined based on evaluations of target, non-target, and new lesions.
    Clinical benefit rate (CBR) is defined as the proportion of patients with best response,
    according to modified RECIST 1.1, of CR, PR, or SD for at least 16 weeks.
    Evaluation of Duration of Treatment, defined as time from randomization to discontinuation of study treatment for any reason.
    To evaluate the Duration of Response measured from the time measurement criterias are first met for CR/PR (whichever is first recorded) per modified RECIST 1.1 until the first date that recurrent disease or PD is objectively documented.
    Overall survival is defined as the interval from the date of randomization to the date of death from any cause.
    Para evaluar la SLP, medida como el intervalo desde la aleatorización hasta la progresión objetiva del tumor o la muerte por cualquier causa, lo que ocurra primero.
    Evaluar la BOR registrada desde el inicio del tratamiento hasta la EoT y se determinará en función de las evaluaciones de las lesiones diana, no diana y nuevas.
    La tasa de beneficio clínico (TBC) se define como la proporción de pacientes con mejor respuesta,
    de acuerdo con RECIST 1.1 modificado, de CR, PR o SD durante al menos 16 semanas.
    Evaluación de la duración del tratamiento, definida como el tiempo desde la aleatorización hasta la interrupción del tratamiento del estudio por cualquier motivo.
    Para evaluar la duración de la respuesta medida a partir de los criterios de medición de tiempo se cumplen primero para CR / PR (lo que se registre primero) por RECIST 1.1 modificado hasta la primera fecha en que la enfermedad recurrente o PD se documenta objetivamente.
    La supervivencia global se define como el intervalo entre la fecha de aleatorización y la fecha de fallecimiento por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    To be measured from the date of randomization to the date of death
    from any cause compared between two treatment arms. Patients who are not known to have died will be censored at the date of last contact, and this will apply as of the date of data cut-off for any particular analysis.
    Se medidará desde la fecha de aleatorización hasta la fecha de la muerte de cualquier causa comparada entre dos brazos de tratamiento. Los pacientes que no se sabe que murieron serán censurados en la fecha del último contacto, y esto se aplicará a partir de la fecha de corte de datos para cualquier análisis en particular.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity; Biomarker assessment;Radiological disease assessment
    Inmunogenicidad; Evaluación de biomarcadores; Evaluación de enfermedades radiológicas
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Belgium
    France
    Hungary
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as completion of the last patient’s last visit.
    Finalización del estudio es definida como la 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 41
    F.4.2.2In the whole clinical trial 64
    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 Decision2018-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
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