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    Summary
    EudraCT Number:2020-004658-32
    Sponsor's Protocol Code Number:BGB-A317-A1217-203
    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:2021-07-08
    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 number2020-004658-32
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody BGB-A1217 Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
    Un estudio de fase II, multicéntrico, aleatorizado, doble ciego y controlado con placebo para comparar la eficacia del anticuerpo monoclonal anti-PD-1 tislelizumab (BGB-A317) más el anticuerpo monoclonal anti-TIGIT (BGB-A1217) frente a tislelizumab más placebo como segunda línea de tratamiento en pacientes con carcinoma esofágico de células escamosas irresecable, localmente avanzado, recurrente o metastásico con PD-L1 con vCPS ≥10 %
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Tislelizumab (BGB-A317) Plus BGB-A1217 Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
    Un estudio de tislelizumab (BGB-A317) más BGB-A1217 frente a tislelizumab más placebo como segunda línea de tratamiento en pacientes con carcinoma esofágico de células escamosas irresecable, localmente avanzado, recurrente o metastásico con PD-L1 con vCPS ≥10 %
    A.4.1Sponsor's protocol code numberBGB-A317-A1217-203
    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 SponsorBeiGene, Ltd.
    B.1.3.4CountrySwitzerland
    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 supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Ltd.
    B.5.2Functional name of contact pointClinical Trial Information Email
    B.5.3 Address:
    B.5.3.1Street Address2955 Campus Drive, Suite 200
    B.5.3.2Town/ citySan Mateo
    B.5.3.3Post codeCA 94403
    B.5.3.4CountryUnited States
    B.5.6E-mailBeigeneClinicalSupportUS@beigene.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 BGB-A1217
    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 INNociperlimab
    D.3.9.2Current sponsor codeBGB-A1217
    D.3.9.3Other descriptive namehumanised IgG1 monoclonal antibody against TIGIT
    D.3.9.4EV Substance CodeSUB218294
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2357
    D.3 Description of the IMP
    D.3.1Product nameTislelizumab
    D.3.2Product code BGB-A317
    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 INNTISLELIZUMAB
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317, BGN1, JHL2108
    D.3.9.4EV Substance CodeSUB193656
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboConcentrate for solution for 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
    PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
    Carcinoma esofágico de células escamosas irresecable, localmente avanzado, recurrente o metastásico con PD-L1 con vCPS ≥10 %
    E.1.1.1Medical condition in easily understood language
    Esophageal Squamous Cell Carcinoma
    Carcinoma esofágico de células escamosas
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061534
    E.1.2Term Oesophageal squamous cell carcinoma
    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 compare the objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), of tislelizumab plus BGB-A1217 with tislelizumab plus placebo as second-line treatment in patients with programmed cell death ligand-1 (PD-L1) visually-estimated Combined Positive Score (vCPS) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in the Intentto-Treat (ITT) Analysis Set.
    • To compare the overall survival (OS) of tislelizumab plus BGB-A1217 with tislelizumab plus placebo as second-line treatment in patients with PD-L1 vCPS ≥ 10% ESCC in the ITT Analysis Set.
    • Comparar la tasa de respuesta objetiva (TRO) evaluada por el investigador de acuerdo con los Criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST v1.1) de tislelizumab más BGB-A1217 con tislelizumab más placebo como tratamiento de segunda línea en pacientes con carcinoma esofágico de células escamosas (CECE) irresecable, localmente avanzado, recurrente o metastásico con ligando de muerte celular programada 1 (PD-L1) con puntuación positiva combinada calculada visualmente (vCPS) ≥10 % en la población de análisis por intención de tratar.
    • Comparar la supervivencia global (SG) de tislelizumab más BGB-A1217 con tislelizumab más placebo como tratamiento de segunda línea en pacientes con CECE con PD-L1 con vCPS ≥10 % en la población de análisis por intención de tratar.
    E.2.2Secondary objectives of the trial
    • To compare the following endpoints between tislelizumab plus BGBA1217 and tislelizumab plus placebo based on tumor assessments per RECIST v1.1: 1-Progression-free survival (PFS) assessed by both the Independent Review Committee (IRC) and the investigator. 2-Duration of response (DOR), disease control rate (DCR), and clinical benefit rate (CBR) assessed by both the IRC and the investigator. 3-ORR assessed by the IRC.
    • To compare the safety and tolerability between tislelizumab plus BGBA1217 and tislelizumab plus placebo.
    • To compare the health-related quality of life (HRQoL) via cancerspecific patient-reported outcomes (PROs) between tislelizumab plus BGB-A1217 and tislelizumab plus placebo.
    • Comparar los siguientes criterios de valoración entre tislelizumab más BGB-A1217 y tislelizumab más placebo sobre la base de evaluaciones tumorales según RECIST v1.1: 1 Supervivencia sin progresión (SSP) evaluada tanto por el Comité de revisión independiente (CRI) como por el investigador. 2 Duración de la respuesta (DdR), tasa de control de la enfermedad (TCE) y tasa de beneficio clínico (TBC) evaluados tanto por el CRI como por el investigador. 3 TRO evaluada por el CRI
    • Comparar la seguridad y tolerabilidad entre tislelizumab más BGB-A1217 y tislelizumab más placebo.
    • Comparar la calidad de vida relacionada con la salud (CVRS) mediante los resultados percibidos por el paciente (RPP) específicos del cáncer entre tislelizumab más BGB-A1217 y tislelizumab más placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of ESCC.
    2. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
    3. Have measurable disease as assessed by RECIST v1.1.
    4. Have confirmed PD-L1 vCPS ≥ 10% in tumor tissues tested by the central lab.
    5. ECOG PS score of 0 or 1.
    1. Diagnóstico de CECE con confirmación histólogica.
    2. PE durante o después de la primera línea de tratamiento sistémico para el CECE irresecable, localmente avanzado, recurrente o metastásico
    3. Enfermedad medible según se define en RECIST v1.1.
    4. PD-L1 con vCPS ≥10 % confirmada en tejidos tumorales analizados por el laboratorio central.
    5. Estado funcional de ECOG de 0 o 1.
    E.4Principal exclusion criteria
    1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
    2. Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
    3. Evidence of complete esophageal obstruction not amenable to treatment.
    4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
    5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
    1. Tratamiento previo con un anticuerpo anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT o cualquier otro anticuerpo o fármaco específicamente dirigido a las vías de coestimulación o de puntos de control de linfocitos T.
    2. Pacientes con evidencia de fístula (ya sea esofágica/bronquial o esofágica/aorta).
    3. Evidencia de obstrucción esofágica completa no susceptible al tratamiento.
    4. Derrame pleural, derrame pericárdico o ascitis no controlados que requieran procedimientos de drenaje frecuentes (recurrencia en las 2 semanas posteriores a la intervención).
    5. Haber recibido quimioterapia, inmunoterapia (p. ej., interleucina, interferón, timosina, etc.) o cualquier tratamiento en investigación en los 14 días o 5 semividas (lo que sea mayor) antes de la primera dosis del fármaco del estudio. O haber recibido radioterapia paliativa u otros tratamientos locorregionales en los 14 días anteriores a la primera dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • ORR, defined as the proportion of patients in the ITT Analysis Set who have complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1.
    • OS, defined as the time from the date of randomization until the date of death due to any cause in patients in the ITT Analysis Set.
    • TRO, definida como la proporción de pacientes de la población de análisis por intención de tratar que tienen una respuesta completa (RC) o una respuesta parcial (RP) de acuerdo con la evaluación del investigador según RECIST v1.1.
    • SG, definida como el tiempo desde la fecha de la aleatorización hasta la fecha de la muerte por cualquier causa en los pacientes de la población de análisis por intención de tratar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint ORR will be tested at a 1-sided alpha of 0.025. If the null hypothesis for ORR in the ITT Analysis Set is rejected, OS will be tested hierarchically in the ITT Analysis Set. The inferential test for OS will be stopped at the non-significant final analysis of ORR in the ITT Analysis Set. The familywise type I error will be strongly controlled at one-sided level 0.025.
    El criterio de valoración principal de la TRO se probará con un alfa unilateral de 0,025. Si se rechaza la hipótesis nula para la TRO en la población de análisis por intención de tratar, la SG se probará jerárquicamente en la población de análisis por intención de tratar. La prueba de inferencia de la SG se suspenderá en el análisis final no significativo de la TRO en la población de análisis por intención de tratar. El error de tipo I familiar se controlará estrechamente en un nivel unilateral de 0,025
    E.5.2Secondary end point(s)
    • ORR, defined as above and assessed by the IRC per RECIST v1.1 in the ITT Analysis Set.
    • PFS, defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) assessed by both the IRC and investigator per RECIST v1.1 or death, whichever occurs first in the ITT Analysis Set.
    • DOR, defined as the time from the first determination of an objective response until the first documentation of PD as assessed by both the IRC and the investigator per RECIST v1.1, or death, whichever comes first in the ITT Analysis Set.
    • DCR, defined as the proportion of patients in the ITT Analysis Set who have CR, PR, and stable disease assessed by both the IRC and the investigator per RECIST v1.1.
    • CBR, defined as the proportion of patients who achieve CR, PR and durable stable disease (stable disease ≥24 weeks).
    • HRQoL, measured by the Global Health Status (GHS)/QoL and Physical Function scales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and scores of Dysphagia, Eating, Reflux and Pain of EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18).
    • Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCICTCAE] version 5.0 [v5.0]), timing, seriousness, and relationship to study drugs, physical examinations, electrocardiograms (ECGs), and laboratory assessments.
    • TRO, como se ha definido antes y evaluada por el CRI según RECIST v1.1 en la población de análisis por intención de tratar.
    • SSP, definida como el tiempo desde la fecha de la aleatorización hasta la fecha de la primera progresión de la enfermedad (PE) documentada evaluada por el CRI y el investigador según RECIST v1.1 o la muerte, lo que ocurra primero, en la población de análisis por intención de tratar.
    • DdR, definida como el tiempo desde la primera determinación de una respuesta objetiva hasta la primera PE documentada conforme a la evaluación tanto del CRI como del investigador según RECIST v1.1 o la muerte, lo que ocurra primero, en la población de análisis por intención de tratar.
    • TCE, definida como la proporción de pacientes en la población de análisis por intención de tratar que manifiestan RC, RP y enfermedad estable según la evaluación del CRI y el investigador conforme a RECIST v1.1.
    • TBC, definida como la proporción de pacientes que logran RC, PR y enfermedad estable duradera (enfermedad estable ≥24 semanas).
    • CVRS, medida por las escalas de estado de salud global (ESG)/CdV y función física del cuestionario de calidad de vida de 30 preguntas (QLQ-C30) de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC) y las puntuaciones de disfagia, alimentación, reflujo y dolor del cuestionario de calidad de vida para el cáncer de esófago de 18 preguntas (QLQ-OES18) de la EORTC.
    • Acontecimientos adversos (AA) y acontecimientos adversos graves (AAG) caracterizados por tipo, frecuencia, severidad (según la clasificación de los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute [NCI-CTCAE], versión 5.0 [v5.0]), momento de aparición, gravedad y relación con los fármacos del estudio, exploraciones físicas, electrocardiogramas (ECG) y evaluaciones analíticas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR assessed by the IRC per RECIST v1.1 in the ITT Analysis Set will be analyzed similarly to the corresponding analysis of ORR assessed by the investigator.
    PFS based on assessment by the IRC and the investigator per RECIST v1.1 will be analyzed in the ITT Analysis Set. The PFS censoring rule will follow the United States (US) Food and Drug Administration (FDA) Guidance for Industry.
    DOR will be analyzed among the responders in the ITT Analysis Set using methods similar to that described for PFS, based on assessment by the IRC and the investigator.
    DCR and CBR assessed by the IRC and investigator per RECIST v1.1 will be summarized similarly as ORR in the ITT Analysis Set and the EAS.
    TRO evaluada por el CRI según RECIST v1.1 en la población de análisis por intención de tratar se analizará de forma similar al análisis correspondiente de la TRO evaluada por el investigador. La SSP basada en la evaluación del CRI y el investigador según RECIST v1.1 se analizará en la población de análisis por intención de tratar. La regla de censura de la SSP seguirá las Instrucciones de la (FDA) de USA. La DdR se analizará entre los pacientes que hayan respondido de la población de análisis por intención de tratar mediante métodos similares a los descritos para la SSP, según la evaluación del CRI y el investigador. DdR y la TBC evaluadas por el CRI y el investigador según RECIST v1.1 se resumirán de manera similar a la TRO en la población de análisis por intención de tratar y la PEE.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    China
    Korea, Republic of
    Russian Federation
    Taiwan
    Ukraine
    Belgium
    France
    Spain
    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
    Last information being collected from the last patient. The last information is defined as the information of death, withdraw consent, completed all study assessments or lost follow-up.
    Última información recopilada del último paciente. La última información se define como la información de muerte, retiro del consentimiento, finalización de todas las evaluaciones del estudio o seguimiento perdido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 148
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 280
    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
    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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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