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    Summary
    EudraCT Number:2019-002871-32
    Sponsor's Protocol Code Number:D3255C00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 number2019-002871-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA)
    Ensayo multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para investigar el uso de benralizumab en la esofagitis eosinofílica (MESSINA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Benralizumab in Patients with Eosinophilic Esophagitis
    Estudio de Benralizumab en Pacientes con Esofagitis Eosinofílica
    A.3.2Name or abbreviated title of the trial where available
    MESSINA
    MESSINA
    A.4.1Sponsor's protocol code numberD3255C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZenecaAB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Ed. Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 namebenralizumab
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive namebenralizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Eosinophilic Esophagitis (EoE)
    Esofagitis Eosinofílica (EoE)
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Esophagitis (EoE)
    Allergic Esophagitis
    Esofagitis Eosinofílica (EoE)
    Esofagitis Alérgica
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064220
    E.1.2Term Eosinophilic esophagitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of benralizumab Dose Regimen 1 (30 mg Q4W) on histologic signs and symptoms of EoE in patients with symptomatic and histologically active EoE.
    Evaluar el efecto del Régimen de dosis 1 de benralizumab (30 mg cada 4 semanas) sobre los signos histológicos y síntomas de esofagitis eosinofílica en pacientes con esofagitis eosinofílica sintomática e histológicamente activa.
    E.2.2Secondary objectives of the trial
    DB treatment period:
    -To evaluate the effect of benralizumab Dose Régimen 1 on clinical features of EoE and disease activity.
    -To evaluate the effect of benralizumab Dose Regimen 1 on patient reported QOL measures.
    -To evaluate the effect of benralizumab Dose Regimen 1 on healthcare resource utilization due to EoE.
    -To evaluate the effect of benralizumab Dose Regimen 1 on patient reported measures of disease severity and health status.
    -To assess the PK and immunogenicity of benralizumab Dose Regimen 1 in patients with EoE.
    -To assess the safety and tolerability of benralizumab Dose Regimen 1 in patients with EoE.
    Período de tratamiento con la dosis de benralizumab:
    - Evaluar el efecto del Régimen de dosis 1 de benralizumab cada cuatro semanas sobre las características clínicas de la esofagitis eosinofílica (EoE) y la actividad de la enfermedad.
    - Evaluar el efecto del Régimen de dosis 1 de benralizumab sobre las medidas de CdV notificadas por el paciente.
    - Evaluar el efecto del Régimen de dosis 1 de benralizumab sobre el uso de recursos sanitarios debido a la EoE.
    - Evaluar el efecto del Régimen de dosis 1 de benralizumab sobre las medidas notificadas por el paciente de la gravedad de la enfermedad y el estado de salud.
    - Valorar la farmacocinética e inmunogenicidad del Régimen de Dosis 1 de benralizumab en pacientes con EoE.
    - Valorar la seguridad y tolerancia del Régimen de Dosis 1 en pacientes con EoE.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    EndoFLIP (Endolumenal Functional Lumen Imaging Probe)
    Objective: To evaluate the effect of benralizumab Dose Regimen 1 on clinical features of EoE and disease activity.
    EndoFLIP (Endolumenal Functional Lumen Imaging Probe)
    Objetivo: Evaluar el efecto del Régimen de dosis 1 de benralizumab sobre las características clínicas de la esofagitis eosinofílica y la actividad de la enfermedad,
    E.3Principal inclusion criteria
    - Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form.
    -Documented previous diagnosis of EoE by endoscopy (documented diagnosis defined as an esophageal count of ≥15 eos/hpf on at least 1 esophageal level) and confirmed diagnosis by a centrally-read esophageal biopsy for the purposes of this study (confirmed diagnosis defined as an esophageal count of ≥15 eos/hpf at 2 or more esophageal levels).
    Two to 4 biopsies should be obtained from both the proximal and distal esophagus.
    Biopsies can be taken from the mid-esophagus for additional evaluation.
    -Must be symptomatic at Visit 1 (run-in period) and Visit 2 (randomization):
    (a) A patient reported average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the run-in period AND
    (b) At least 2 days with an episode of dysphagia (Daily DSQ ≥2) per week between Visit 1 and the Visit 2 (randomization).
    -Must be adherent to daily diary assessments:
    (a) Must complete 70% of daily diaries between Visit 1 and Visit 2; AND
    (b) Must have completed at least 8 of 14 daily diaries in the 14 days prior to randomization.
    -May be on background medications for EoE and related treatments during the study as long as the background medications have been stable for at least 4 weeks prior to the run-in period.
    -Body weight of at least 35 kg.
    -Negative serum pregnancy test for female patients of childbearing potential at Visit1.
    -Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 16 weeks after last dose if IP.
    - Pacientes de 12 a 65 años, ambos inclusive, en el momento de firmar el documento de consentimiento o asentimiento (si procede) informado.
    - Diagnóstico previo documentado de esofagitis eosinofílica (EE) mediante endoscopia (el diagnóstico documentado se define como un recuento esofágico ≥ 15 eosinófilos por campo de gran aumento (eos/cga) en al menos 1 nivel esofágico) y diagnóstico confirmado mediante una biopsia esofágica evaluada centralmente para los fines de este estudio (el diagnóstico confirmado se define como un recuento esofágico ≥ 15 eos/cga en 2 o más niveles esofágicos).
    Deben obtenerse de 2 a 4 biopsias de las porciones proximal y distal del esófago.
    Pueden tomarse biopsias de la mitad del esófago para una evaluación adicional.
    - Deben estar sintomáticos en las visitas 1 (período de preinclusión) y 2 (aleatorización):
    a) Promedio comunicado por el paciente de al menos 2 días por semana con un episodio de disfagia durante las 4 semanas previas al período de preinclusión Y
    b) Al menos 2 días con un episodio de disfagia (DSQ diario ≥ 2) a la semana entre la visita 1 y la visita 2 (aleatorización).
    - Deben cumplir las evaluaciones del diario todos los días:
    a) Deben cumplimentar el 70% de los diarios entre las visitas 1 y 2; Y
    b) Deben haber cumplimentado al menos 8 de 14 diarios en los 14 días previos a la aleatorización.
    - Podrán recibir medicación de base para la FDE y tratamientos relacionados durante el estudio siempre que la medicación de base se haya mantenido estable durante al menos 4 semanas antes del período de preinclusión.
    - Peso corporal de al menos 35 kg.
    - Prueba de embarazo en suero negativa en las mujeres en edad fértil en la visita 1.
    - Las mujeres en edad fértil deben comprometerse a utilizar un método anticonceptivo muy eficaz (confirmado por el investigador) desde la aleatorización y durante todo el estudio y durante las 16 semanas siguientes a la última dosis del PEI.
    E.4Principal exclusion criteria
    -Other GI disorders such as active Helicobacter pylori infection, history of achalasia,
    esophageal varices, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, or
    celiac disease.
    -Esophageal stricture that prevents the easy passage of a standard endoscope or any critical
    esophageal stricture that requires dilation during the run-in period.
    -Use of a feeding tube, or not eating solid food daily during the run-in period.
    -Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood
    eosinophil count >1500 eos/μL.
    -EGPA vasculitis.
    -Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy.
    -Current malignancy, or history of malignancy with some specific exceptions.
    - History of anaphylaxis to any biologic therapy or vaccine.
    - Current active liver disease:
    *Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen
    [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria.
    *Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the
    upper limit of normal (ULN), confirmed by repeated testing during the run-in period.
    -Helminth parasitic infection diagnosed within 24 weeks prior to the date informed
    consent or assent (if applicable) is obtained that has not been treated with or has failed to
    respond to standard of care therapy.
    -History of known immunodeficiency disorder including a positive human
    immunodeficiency virus (HIV) test.
    -Concomitant use of immunosuppressive medication.
    -Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to start of the run-in period.
    -Currently pregnant, breastfeeding, or lactating women.
    -Otros trastornos gastrointestinales, como infección activa por Helicobacter pylori, antecedentes de acalasia, varices esofágicas, enfermedad de Crohn, colitis ulcerosa, enfermedad inflamatoria intestinal o enfermedad celíaca.
    -Estenosis esofágica que impida el paso fácil de un endoscopio estándar o cualquier estenosis esofágica crítica que precise dilatación durante el periodo de preinclusión.
    -Uso de una sonda de alimentación o no comer alimentos sólidos a diario durante el período de preinclusión.
    -Síndrome hipereosinofílico, definido por afectación multiorgánica y recuento persistente de eosinófilos en sangre > 1500 eos/μl.
    -Vasculitis GEPA (granulomatosis eosinofílica con poliangitis).
    -Gastritis, gastroenteritis, enteritis o colitis eosinofílicas documentadas mediante biopsia.
    -Neoplasia maligna actual o antecedentes de neoplasia maligna con algunas excepciones específicas.
    -Antecedentes de anafilaxia a cualquier tratamiento biológico o vacuna.
    - Hepatopatía activa actual:
    *Son aceptables la hepatitis B y C estable crónica (incluida una prueba positiva para el antígeno de superficie del virus de la hepatitis B [HBsAg] o anticuerpos contra el virus de la hepatitis C) u otra hepatopatía crónica estable si el paciente cumple los demás criterios de elegibilidad.
    *Concentración de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) ≥ 3 veces el límite superior de la normalidad (LSN), confirmada mediante análisis repetidos durante el período de preinclusión.
    -Infección parasitaria helmíntica diagnosticada en las 24 semanas previas a la fecha de obtención del consentimiento o asentimiento informado (si procede) que no haya sido tratada o no haya respondido al tratamiento habitual.
    -Antecedentes de trastorno de inmunodeficiencia conocido, incluido un resultado positivo en la prueba del virus de la inmunodeficiencia humana (VIH).
    -Uso concomitante de medicación inmunosupresora.
    -Inicio o cambio de una dieta de eliminación de alimentos o reintroducción de un grupo de alimentos eliminado anteriormente en las 6 semanas previas al inicio del período de preinclusión.
    - Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Dual-primary Endpoints:
    -Proportion of patients with a histologic response at Week 24, defined as a peak esophageal
    intraepithelial eosinophil count ≤ 6 eos/hpf
    - Changes from baseline in DSQ score at Week 24
    Criterio de valoración principal doble:
    -Proporción de pacientes con respuesta histológica en la semana 24, definida como un recuento intraepitelial esofágico máximo de eosinófilos ≤ 6 eos/cga.
    -Variación de la puntuación DSQ entre el momento basal y la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both at Week 24
    Ambos en la semana 24
    E.5.2Secondary end point(s)
    Study Objectives for the DB treatment period:
    -Key secondary endpoint: Changes from baseline in centrally-read EoE EREFS at Week 24
    -Centrally-read biopsies for additional histopathology and tissue eosinophil counts,
    including EoE-HSS, at Week 24
    -Dysphagia-free days as captured by the DSQ
    -Frequency of dysphagia episodes as captured by the EoE-3D
    -Changes from baseline in dysphagia associated pain, discomfort, and overall severity as captured by the EoE-3D at Week 24
    -Changes from baseline in abdominal pain and nausea as captured by the daily diary at Week 24
    -Changes from baseline in EoE-QoL-A at Week 24
    -SF-36 v2 Health Survey at Week 24
    - Percent of patients with relevant concomitant procedures and healthcare resource utilization during the study through Week 24
    -PGI-S at Week 24
    - PGI-C at Week 24
    -Serum benralizumab concentration
    -ADA and nAb
    -Safety and tolerability will be evaluated in terms of AEs, Vital signs, and Clinical laboratory values
    Objetivos del estudio para el periodo de tratamiento doble ciego:
    -Criterio de valoración secundario fundamental: Variación de la puntuación EoE EREFS interpretada de forma centralizada entre el momento basal y la semana 24.
    -Biopsias evaluadas de forma centralizada en cuanto a otros parámetros histopatológicos y recuentos tisulares de eosinófilos, incluida la puntuación EoE HSS, en la semana 24.
    -Días sin disfagia según lo registrado por el DSQ.
    -Frecuencia de los episodios de disfagia según lo registrado por el EoE-3D.
    -Variaciones del dolor y las molestias asociados a la disfagia y la intensidad global según lo determinado por el EoE-3D entre el momento basal y la semana 24.
    -Variaciones del dolor abdominal y las náuseas registradas en el diario el momento basal y la semana 24.
    -Variación de la puntuación EoE-QoL-A entre el momento basal y la semana 24.
    -Cuestionario de salud SF-36 v2 en la semana 24
    -Porcentaje de pacientes con procedimientos concomitantes relevantes y utilización de recursos sanitarios durante el ensayo hasta la semana 24.
    -Puntuación PGI-S en la semana 24.
    -Puntuación PGI-C en la semana 24.
    -Concentración sérica de benralizumab.
    -ACF y AcN.
    -La seguridad y la tolerabilidad se evaluarán en cuanto a AA, constantes vitales y valores analíticos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varies depending on the endpoint/objective
    Variable dependiendo del criterio de valoración/objetivo
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Samples collected for the Genomics Initiative are considered primary use and will be whole exome or whole genome sequenced. Analysis will be performed for both known and novel health related genes and this broad genetic research will not restrict to disease or drug. Sequencing data generated is for research purposes only and cannot be used for clinical decision making and there will not be any clinical endpoints delivered to the study, as a result of testing performed.
    La muestras recogidas para iniciativa genómica son consideradas para uso primario y será secuenciado el exoma o genoma completo. El análisis se hará para los genes conocidos y para los nuevos relacionados con la salud y esta amplia investigación genética no se restringirá a la enfermedad/medicamento.La secuencia de datos generados tiene sólo fines de investigación, no se pueden usar para decisiones clínicas y no habrá objetivos clínicos enviados al estudio,como un resultado del test realizado.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Tras tto. doble ciego con benralizumab, los pacientes continuarán con RD1 abierto hasta la semana 52
    Following DB treatment,patients will continue with Open Label benralizumab DosingRegimen1 to Week 52
    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 EEA39
    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
    Canada
    France
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the last expected visit/contact of the last patient undergoing the
    study.
    El fin del estudio se define como la última visita/contacto del último paciente 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 months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) No
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 107
    F.4.2.2In the whole clinical trial 170
    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)
    Upon completion of the initial 52-week treatment period, patients will be invited to an additional 52-week Open Label Extension of benralizumab Dosing Regimen 1 for an another 52 weeks, with ongoing study assessments. After completion of the study, patients will exit the trial and will return to care under their clinician’s direction.
    Una vez completado el período de tratamiento inicial de 52 semanas, los pacientes serán invitados a una extensión adicional de 52 semanas con el Régimen de Dosis 1 de benralizumab durante otras 52 semanas, con evaluaciones del estudio en curso. Tras completar el estudio, los pacientes saldrán del ensayo y volverán a ser atendido bajo su asistencia médica habitual.
    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 Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
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