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    Summary
    EudraCT Number:2018-003428-35
    Sponsor's Protocol Code Number:KSI-CL-102
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-06
    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 number2018-003428-35
    A.3Full title of the trial
    A Phase 2, Prospective, Randomised, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects with Neovascular (Wet) Age-related Macular Degeneration
    Estudio fase 2, multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento y controlado con un comparador activo para investigar la eficacia y la seguridad de la administración intravítrea repetida de KSI-301 en sujetos con degeneración macular neovascular (húmeda) asociada a la edad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Intravitreal KSI-301 in Patients With Neovascular (Wet) Age-related Macular Degeneration
    Estudio de la administración intravítrea de KSI-301 en pacientes con degeneración macular neovascular (húmeda) asociada a la edad
    A.4.1Sponsor's protocol code numberKSI-CL-102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04049266
    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 SponsorKodiak Sciences Inc.
    B.1.3.4CountryUnited States
    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 supportKodiak Sciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKodiak Sciences Inc
    B.5.2Functional name of contact pointKSI-CL-102 Trial Information
    B.5.3 Address:
    B.5.3.1Street Address2631 Hanover Street
    B.5.3.2Town/ cityPalo, Alto, California
    B.5.3.3Post code94304
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    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 nameKSI-301 Drug Product
    D.3.2Product code KSI-301
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available or proposed
    D.3.9.2Current sponsor codeOG1953
    D.3.9.3Other descriptive nameOG1953 Drug Substance
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAFLIBERCEPT
    D.3.9.1CAS number 862111-32-8
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Neovascular (Wet) Age-related Macular Degeneration
    Degeneración macular neovascular (húmeda) asociada a la edad
    E.1.1.1Medical condition in easily understood language
    Neovascular (Wet) Age-related Macular Degeneration
    Degeneración macular neovascular (húmeda) asociada a la edad
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10067791
    E.1.2Term Wet macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in BCVA from Day 1 to Year 1. Year 1 is defined as the mean of the Week 48 and 52 measurements.
    Demostrar que KSI-301 5 mg no es inferior a aflibercept 2 mg en cuanto a la variación media de la MAVC (BCVA por sus siglas en inglés) entre el día 1 y el año 1. El año 1 se define como la media de las determinaciones de las semanas 48 y 52.
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of KSI-301 5 mg compared to aflibercept 2 mg over the study duration of 96 weeks by assessing visual and anatomical parameters.
    •To evaluate the proportion of subjects maintained on a Q12W, Q16W, or Q20W dosing regimen of KSI-301 over the duration of the first 52 weeks.
    •To evaluate the safety and tolerability of KSI-301 5 mg compared to aflibercept 2 mg.
    •To assess the systemic pharmacokinetics and immunogenicity of KSI-301.
    •Evaluar la eficacia de KSI-301 5 mg en comparación con aflibercept 2 mg durante el estudio de 96 semanas mediante la determinación de parámetros visuales y anatómicos.
    •Evaluar la proporción de sujetos que mantengan una pauta de administración cada 12, 16 o 20 semanas de KSI-301 durante las primeras 52 semanas.
    •Evaluar la seguridad y la tolerabilidad de KSI-301 5 mg en comparación con aflibercept 2 mg.
    •Evaluar la farmacocinética sistémica y la inmunogenicidad de KSI-301
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferation (RAP) lesions with a CNV component that affect the central subfield as evidenced by FA or OCT in the Study Eye at Screening.
    2.The CNV area in the Study Eye must be at least 50% of total lesion size at Screening.
    3.A lesion area <30 mm2 (12 disc areas) of any CNV lesion subtype in the Study Eye.
    4.Intra and/or subretinal fluid and/or SHRM (subretinal hyperreflective material) affecting the central subfield of the Study Eye on OCT at Screening.
    5.BCVA ETDRS score between 80 and 25 letters (20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye at Screening and reconfirmed at Day 1.
    6.Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wet AMD.
    7.Only one eye per subject is eligible to participate in the study.
    1.Neovascularización coroidea (NVC) activa, no tratada previamente, secundaria a DMAE, incluidas lesiones subfoveales, yuxtafoveales y extrafoveales o lesiones de proliferación angiomatosa retiniana (PAR) con un componente de NVC que afecten al subcampo central, demostradas mediante AF o TCO en el ojo evaluado en la selección.
    2.Superficie de NVC en el ojo evaluado correspondiente al 50%, como mínimo, del tamaño total de lesión en la selección.
    3.Superficie de lesión < 30 mm2 (12 superficies papilares) de cualquier subtipo de lesión de NVC en el ojo evaluado.
    4.Líquido intra y/o subretiniano y/o material hiperreflectante subretiniano (MHSR) que afecta al subcampo central del ojo evaluado en la TCO en la selección.
    5.Puntuación de MAVC según el optotipo ETDRS de entre 80 y 25 letras (de 20/25 a 20/320 equivalente de Snellen), ambas inclusive, en el ojo evaluado en la selección y reconfirmada el día 1.
    6.Disminución de la visión en el ojo evaluado debida principalmente, según el investigador, a DMAE húmeda.
    7. En el estudio solo podrá optar a participar un ojo por sujeto.
    E.4Principal exclusion criteria
    1.BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
    2.Active ocular or periocular infection or inflammation in either eye at Day 1.
    3.CNV secondary to other causes in the Study Eye, including pathologic myopia, angioid streaks, prior trauma, ocular histoplasmosis, or others.
    4.Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid, such as central serous chorioretinopathy.
    5.Fibrosis or atrophy of >50% of the lesion size and/or involving the foveal center of the Study Eye at Screening.
    6.Subretinal blood affecting the foveal center of the Study Eye and/or more than 50% of the lesion size at Screening.
    7.Any approved or investigational treatment for neovascular AMD (other than oral vitamin supplements) in the Study Eye at any time.
    8.Prior macular laser (e.g., thermal laser or photodynamic therapy laser) in the Study Eye.
    1.MAVC de movimiento de la mano o peor en el ojo no evaluado o ausencia física de un ojo no evaluado (es decir, sujeto monocular).
    2.Infección o inflamación ocular o periocular activa en cualquier ojo el día 1.
    3.NVC secundaria a otras causas en el ojo evaluado, como miopía patológica, estrías angioides, traumatismo previo, histoplasmosis ocular u otras.
    4.Antecedentes de procesos maculares no relacionados con la DMAE, pero que afecten a la visión o contribuyan al líquido sub o intrarretiniano, como coriorretinopatía serosa central.
    5.Fibrosis o atrofia correspondiente a más del 50% del tamaño de lesión y/o que afecta al centro de la fóvea del ojo evaluado en la selección.
    6.Sangre subretiniana que afecta al centro de la fóvea del ojo evaluado y/o a más del 50% del tamaño de lesión en la selección.
    7.Cualquier tratamiento aprobado o experimental contra la DMAE neovascular (aparte de suplementos vitamínicos orales) en el ojo evaluado en cualquier momento.
    8.Laserterapia macular previa (p. ej., láser térmico o laserterapia fotodinámica) en el ojo evaluado.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be the mean change in BCVA from Day 1 to Year 1, comparing subjects receiving KSI-301 to aflibercept at a non-inferiority margin of 4 letters. Year 1 is defined as the mean BCVA at Weeks 48 and 52.
    La variable principal del estudio será la variación media de la MAVC entre el día 1 y el año 1, comparando sujetos que reciban KSI-301 y aflibercept con un margen de no inferioridad de 4 letras. El año 1 se define como la media de la MAVC en las semanas 48 y 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 48 and 52
    Semanas 48 y 52
    E.5.2Secondary end point(s)
    At Year 1:
    •Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301 at 52 weeks.
    •Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from baseline over time.
    •Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from baseline over time.
    •Mean change from baseline in BCVA from baseline to Week 12, Week 16, and over time.
    •Proportion of subjects with BCVA Snellen equivalent of 20/40 or better from baseline over time.
    •Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse from baseline over time.
    •Mean change in OCT central subfield retinal thickness (CST) from baseline to Week 12, Week 16, and over time.
    •Mean change in OCT intraretinal fluid volume from baseline to Week 12, Week 16, and over time.
    •Mean change in OCT subretinal fluid volume from baseline to Week 12, Week 16, and over time.
    •Proportion of subjects without intraretinal fluid on OCT from baseline to Week 12, Week 16 and over time.
    •Proportion of subjects without subretinal fluid on OCT from baseline to Week 12, Week 16 and over time.
    •Proportion of subjects without pigment epithelial detachments on OCT from baseline over time.
    •Mean change in CNV total lesion area on FA from baseline at Year 1.
    •Mean chance in area of leakage on FA from baseline at Year 1.
    •Number of study drug injections received in the KSI-301 and aflibercept groups through.

    Year 1
    •For the KSI-301 group, the predictability of being on Q12W, Q16W, or Q20W dosing at the end of Year 1 on the basis of the first set of disease activity assessments (at weeks 20 and 24).

    At Year 2:
    •Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from baseline over time.
    •Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from baseline over time.
    •Mean change from baseline in BCVA from baseline over time.
    •Proportion of subjects with BCVA Snellen equivalent of 20/40 or better from baseline over time.
    •Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse from baseline over time.
    •Mean change in OCT central subfield retinal thickness (CST) from baseline over time.
    •Mean change in OCT intraretinal fluid volume from baseline to Week 12, Week 16, and over time.
    •Mean change in OCT subretinal fluid volume from baseline to Week 12, Week 16, and over time.
    •Proportion of subjects without intraretinal fluid on OCT from baseline over time.
    •Proportion of subjects without subretinal fluid on OCT from baseline over time.
    •Proportion of subjects without pigment epithelial detachments on OCT from baseline over time.
    •Mean change in CNV total lesion area on FA from baseline at Year 2
    •Mean chance in area of leakage on FA from baseline at Year 2.

    For BCVA and OCT, Year 1 is defined as the average measurement at Weeks 48 and 52 and Year 2 is defined as the average measurement at Weeks 92 and 96.

    A full list of secondary endpoints, including the delineation of key versus additional secondary endpoints, will be outlined in the SAP.
    Al año 1:
    •Proporción de sujetos con una pauta de administración cada 12, 16 o 20 semanas de KSI-301 a las 52 semanas.
    • Proporción de sujetos que incrementan ≥ 5, ≥10 y ≥15 letras desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos que pierden ≥ 5, ≥10 and ≥15 letras desde el momento basal y a lo largo del tiempo.
    •Variación media en la MAVC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Proporción de sujetos con un equivalente Snellen de la MAVC de 20/40 o mejor desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos con un equivalente Snellen de la MAVC de 20/200 o peor desde el momento basal y a lo largo del tiempo.
    •Variación media en OTC CST (“central subfield retinal thickness”) desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Variación media en el volumen del líquido intraretiniano por OTC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Variación media en el volumen del líquido subretiniano por OTC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Proporción de sujetos sin líquido intraretiniano en OTC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Proporción de sujetos sin líquido subretiniano en OTC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Proporción de sujetos sin desprendimientos del pigmento epitelial en OTC desde el momento basal y a lo largo del tiempo.
    •Variación media de la neovascularización coroidea en el área total de lesión en AF desde el momento basal al año 1.
    •Promedio del área de fuga en la AF desde el momento basal hasta el año 1.
    •Número de inyecciones de la medicación del estudio recibidas en los grupos de KSI-301 y aflibercept.

    Año 1
    •Para el grupo de KSI-301, previsibilidad de una pauta de dosis cada 12, 16 o 20 semanas al final del año 1, en base al primer grupo de evaluaciones de la actividad de la enfermedad (en las semanas 20 y 24).

    Al año 2:
    • Proporción de sujetos que incrementan ≥ 5, ≥10 y ≥15 letras desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos que pierden ≥ 5, ≥10 and ≥15 letras desde el momento basal y a lo largo del tiempo.
    •Variación media en la MAVC desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos con un equivalente Snellen de la MAVC de 20/40 o mejor desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos con un equivalente Snellen de la MAVC de 20/200 o peor desde el momento basal y a lo largo del tiempo.
    •Variación media en OTC CST (“central subfield retinal thickness”) desde el momento basal y a lo largo del tiempo.
    Variación media en el volumen del líquido intraretiniano por OTC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Variación media en el volumen del líquido subretiniano por OTC desde el momento basal a la semana 12, 16 y a lo largo del tiempo.
    • Proporción de sujetos sin líquido intraretiniano en OTC desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos sin líquido subretiniano en OTC desde el momento basal y a lo largo del tiempo.
    • Proporción de sujetos sin desprendimientos del pigmento epitelial en OTC desde el momento basal y a lo largo del tiempo.
    •Variación media de la neovascularización coroidea en el área total de lesión en AF desde el momento basal al año 2.
    •Promedio del área de fuga en la AF desde el momento basal hasta el año 2.

    Para la MAVC y OTC, se define el año 1 como el valor medio de las mediciones en las semanas 48 y 52 y el año 2 se define como la For BCVA and OCT, como el valor medio de las mediciones en las semanas 92 y 96.

    Una lista completa de las variables secundarias , incluyendo la descripción de variables secundarias clave versus adicionales, se detallarán en el plan de análisis estadístico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Year 1 and Year 2
    Año 1 y Año 2
    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 No
    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) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Israel
    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
    The end of the study according to the protocol is defined as the last follow-up visit of the last subject enrolled (that is, the last subject enrolled’s Week 96 visit) or a Sponsor decision to terminate the study, whichever comes first. Study data may be collected beyond the end of the study.
    El final del estudio de acuerdo con el protocolo se define como la última visita de seguimiento del último sujeto incluido (es decir, la visita de la semana 96 del último sujeto incluido) o una decisión del Promotor de finalizar el estudio, lo que ocurra primero. Los datos del estudio pueden recopilarse más allá del final del estudio.
    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
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 331
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 181
    F.4.2.2In the whole clinical trial 368
    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)
    After subjects complete their final follow-up visit or discontinue from the study prematurely, all subjects will return to standard of care treatment at the discretion of their treating physician. The Sponsor will not provide continued access to study treatment following the end of the study or the end of each subject’s study treatment period.
    Después de que los sujetos completen su visita de seguimiento final o abandonen el estudio prematuramente, todos volverán al tratamiento estándar a criterio de su médico habitual. El Promotor no proporcionará acceso continuo al tratamiento del estudio después del final del mismo o al final del período de tratamiento del estudio de cada sujeto.
    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 Decision2019-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-24
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