Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43724   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2019-002039-27
    Sponsor's Protocol Code Number:D3254C00001
    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:2023-01-31
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-002039-27
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)
    Estudio en fase III multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, de 24 semanas con extensión abierta para evaluar la eficacia y la seguridad de benralizumab en pacientes con síndrome hipereosinofílico (SHE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if benralizumab may be beneficial in the treatment of Hypereosinophilic Syndrome (HES)
    Un estudio para evaluar si benralizumab puede ser beneficioso en el tratamiento del síndrome hipereosinofílico (SHE)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD3254C00001
    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.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 supportAstraZenecaAB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE-151 85
    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 Yes
    D. name Fasenra
    D. of the Marketing Authorisation holderAstraZeneca AB
    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.3.1Product 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Hypereosinophilic Syndrome (HES)
    Síndrome hipereosinofílico (SHE)
    E.1.1.1Medical condition in easily understood language
    Hypereosinophilic Syndrome (HES)
    Síndrome hipereosinofílico (SHE)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    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 on the time to first HES worsening/flare
    Evaluar el efecto de benralizumab en el tiempo hasta el primer empeoramiento/exacerbación del SHE
    E.2.2Secondary objectives of the trial
    For DB period to evaluate the effect of benralizumab on:
    -time to 1st haematological relapse
    -proportion of patients (1) who experience HES worsening/flare (2) with haematologic relapse and (3) who maintain absolute eosinophil count (AEC) <500 cells/μL for 24 weeks
    -corticosteroid use
    -patient-reported measure of fatigue
    -health status and HRQoL: SF-36v2, PGIS, PGIC
    And also the safety, tolerability, pharmacokinetics and immunogenicity of benralizumab in patients with HES

    For OLE extension period to evaluate the effect of benralizumab on:
    -proportion of patients who experience HES worsening/flare and on the number of HES worsening/flare (a)
    -patient reported measure of fatigue (b)
    -HRQoL (b)
    (a) Applicable to full duration of OLE
    (b) Applicable to 1st year of OLE only
    Please refer to the protocol for a full list of secondary objetives
    Para el periodo de tratamiento DC evaluar el efecto de benralizumab en:
    -el tiempo hasta la primera recidiva hematológica
    -la proporción de pacientes (1)que experimentan un empeoramiento/exacerbación del SHE (2)con recidiva hematológica y (3)que mantienen un RAE <500 células/μl durante 24 semanas
    -el uso de corticoesteroides
    -la medida de la fatiga notificada por el paciente
    -las medidas del estado de salud/CdVRS: SF-36v2,PGIS,PGIC
    Y también evaluar la seguridad, farmacocinetica y la inmunogenicidad de benralizumab en pacientes con SHE

    Para el periodo de tratamiento de EA evaluar el efecto de benralizumab en:
    -la proporción de pacientes que experimentan un empeoramiento/exacerbación del SHE y en el número de empeoramientos/exacerbaciones del SHE(a)
    -la medida de la fatiga notificada por el paciente(b)
    (a)Aplicable a la duración completa de la EA
    (b)Aplicable al 1er año de EA solamente
    Por favor consulte el protocolo para lista completa de objetivos secundarios
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Mechanistic sub-study: To support identifying predictors and mechanisms of response to benralizumab in adults. The additional exploratory analyses will be performed from three whole blood samples:
    - for DNA analysis to determine clinical subtype of HES by targeted PCR (all study sites).
    - for more in-depth phenotyping of lymphocytes and other leukocytes by flow cytometry of peripheral blood mononuclear cells (PBMC) (all study sites).
    - for phenotyping of eosinophils by flow cytometry (only selected mechanistic sub-study sites)

    Patient qualitative interview sub-study: to characterise the impact of HES on patients´lives and their experiences with the study treatment (selected sites only).
    Subestudio mecanicista: Apoyar la identificación de predictores y mecanismos de respuesta a benralizumab en adultos. Los análisis exploratorios adicionales se realizarán a partir de tres muestras de sangre total:
    -para análisis de ADN con el fin de determinar el subtipo clínico de SHE mediante PCR dirigida (todos los centros del estudio).
    -para un fenotipado más exhaustivo de los linfocitos y otros leucocitos mediante citometría de flujo de células mononucleares de sangre periférica (PBMC) (todos los centros del estudio).
    -para el fenotipado de los eosinófilos mediante citometría de flujo (sólo centros seleccionados de subestudios mecanicistas)

    Subestudio de entrevistas cualitativas a pacientes: para caracterizar el impacto de la SHE en la vida de los pacientes y sus experiencias con el tratamiento del estudio (sólo en centros seleccionados).
    E.3Principal inclusion criteria
    1. Provision of the signed and dated written informed consent of the patient or the patient’s legally authorised representative, and informed assent from the patient (per local regulations) prior to any mandatory study-specific procedures, sampling, and analyses
    2. Males and females 12 years of age and older at the time of signing the ICF
    3. Documented diagnosis of HES (history of persistent eosinophilia >1500 cells/μL without
    secondary cause on 2 examinations [interval ≥1 month; Valent et al 2012] and evidence of end organ manifestations attributable to the eosinophilia)
    4. Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene translocation
    5. Stable HES treatment dose(s) and regimen for for ≥4 weeks at the time of Visit 1
    6. Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of HES worsening/flare (other than isolated eosinophilia) at Visit 1 or a documented history of 2 or more HES worsening/flares within 12 months prior to Visit 1 requiring an escalation in therapy.
    -At least one flare within the past 12 months must not be related to a decrease in HES therapy during the 4 weeks prior to the flare.
    7. AEC ≥1000 cells/μL at Visit 1 (assessed by local laboratory)
    8. Corticosteroid responsiveness defined as an AEC <1000 cells/μL after a 2-day course of OCS (prednisone/prednisolone) 1 mg/kg/day at Visit 2 (assessed by local laboratory). Other OCSs in equivalent doses are permitted.
    9. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control (confirmed by the Investigator) from enrolment, throughout the study duration, and within 12 weeks after last dose of IP and have a negative urine dipstick pregnancy test result on Visit 1
    10. Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for ≥12 months prior to the planned date of enrolment without an alternative medical cause
    1. Disponer del consentimiento informado por escrito, firmado y fechado del paciente o de su representante legal y del asentimiento informado del paciente (según la normativa local) antes de realizar procedimientos, obtenciones de muestras y análisis obligatorios y específicos del estudio
    2. Hombres y mujeres que tengan 12 años o más en el momento de la firma del FCI
    3. Diagnóstico documentado de SHE (antecedentes de eosinofilia persistente >1500 células/μl sin causa secundaria en 2 exploraciones [intervalo ≥1 mes; Valent et al 2012] e indicios de manifestaciones en los órganos afectados, atribuibles a la eosinofilia)
    4. Prueba negativa documentada para la translocación del gen de fusión de la tirosina-cinasa FIP1L1-PDGFRA
    5. Dosis y pautas posológicas estables del tratamiento para el SHE durante ≥4 semanas en el momento de la visita 1
    6. Signos o síntomas de empeoramiento/exacerbación del SHE o anomalías de laboratorio indicativas de empeoramiento/exacerbación del SHE (distinto de eosinofilia aislada) en la visita 1 o antecedentes documentados de 2 o más empeoramientos/exacerbaciones del SHE en los 12 meses anteriores a la visita 1 que requirieran un aumento escalonado del tratamiento.
    -Como mínimo, una de las exacerbaciones en los últimos 12 meses no debe estar relacionada con una disminución del tratamiento del SHE durante las 4 semanas anteriores a la exacerbación.
    7. RAE ≥1000 células/μl en la visita 1 (evaluado por el laboratorio local)
    8. Capacidad de respuesta a los corticoesteroides definida como un RAE <1000 células/μl después de un ciclo de 2 días de 1 mg/kg/día de OCS (prednisona/prednisolona) en la visita 2 (evaluado por el laboratorio local). Se permiten otros OCS en dosis equivalentes.
    9. Las mujeres con capacidad de concebir (MCC) deben aceptar usar un método anticonceptivo altamente eficaz (confirmado por el investigador) a partir de la inclusión, durante todo el estudio y en las 12 semanas posteriores a la última dosis del PEI, y deben tener un resultado negativo en una prueba de embarazo con tira reactiva en orina en la visita 1
    10. Se definen como mujeres sin capacidad de concebir a aquellas que se han sometido a esterilización permanente (histerectomía, ovariectomía bilateral o salpingectomía
    bilateral) o que son posmenopáusicas. Las mujeres se considerarán posmenopáusicas si han tenido amenorrea durante ≥12 meses antes de la fecha de inclusión prevista, sin una causa médica alternativa.
    E.4Principal exclusion criteria
    1. Life-threatening HES and/or HES complication(s) as judged by the Investigator:
    (a) Medical intervention for HES-related life-threatening event(s) within 12 weeks prior to randomization, (b) History of thrombotic complications, stroke, or significant cardiac damage related to HES, if the respective events were life threatening and currently represent a risk of life-threatening disease complications. Events that occurred in the past but considered resolved or stable, can be accepted if, as per Investigator's judgment participation in the study will not put the patient at risk c) Disease severity that, in the opinion of the Investigator, makes the patient inappropriate for inclusion in the study
    2. Presence of FIP1L1-PDGFRA fusion tyrosine kinase gene translocation or other known imatinib-sensitive mutation
    3. Definitive diagnosis of eosinophilic granulomatosis with polyangiitis
    4. Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities that are not associated with HES and are uncontrolled with standard treatment which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete the entire duration of the study
    5.Hypereosinophilia of unknown significance
    6. Cardiovascular: Documented history of any clinically significant cardiac damage, clinically significant echocardiography (if available) or ECG findings within 12 months prior to Visit 1 or clinically significant ECG findings at screening that, in the opinion of the Investigator, may put the patients at risk.
    7. Known currently active liver disease
    (a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen or hepatitis C antibody) or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis
    (b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3× the upper limit of normal (ULN) during the screening period (AST or ALT >5×ULN if documented HES with liver manifestations). Transient increase of AST/ALT level that resolves by the time of randomisation is acceptable if, in the Investigator’s opinion, the patient does not have an active liver disease and meets other eligibility criteria
    8. Current malignancy, or history of malignancy, except:
    (a) Patients who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided the patient is in remission and curative therapy was completed at least 12 months prior to the date that informed consent, and assent when applicable, was obtained
    (b) Patients who have had other malignancies are eligible provided the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained
    9. Diagnosis of systemic mastocytosis
    10. Chronic or ongoing active infections requiring systemic treatment, as well as clinically significant viral, bacterial, or fungal infection within 4 weeks prior to Visit 1
    11. A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1 that has not been treated or has failed to respond to standard of care therapy. A confirmation of a complete resolution of any helminth parasitic infection prior to Visit 1 should be available
    12. A history of known immunodeficiency disorder other than that explained by the use of
    OCS or other therapy taken for HES. Positive human immunodeficiency virus (HIV) test.

    Please refer to the protocol for a full list of exclusion criteria
    1. SHE o complicaciones del SHE potencialmente mortales a criterio del investigador:
    (a) Intervención médica por acontecimientos potencialmente mortales relacionados con el SHE en las 12 semanas anteriores a la aleatorización, (b) Antecedentes de complicaciones trombóticas, accidente cerebrovascular o daño cardíaco significativo, relacionados con el SHE, si los respectivos acontecimientos fueron potencialmente mortales y actualmente representan un riesgo de complicaciones de la enfermedad potencialmente mortales. Los acontecimientos que se hayan producido en el pasado, pero se consideren resueltos o estables, pueden aceptarse si, a criterio del investigador, la participación en el estudio no pondrá en riesgo al paciente, (c) Gravedad de la enfermedad que, en opinión del investigador, hace que el paciente sea inadecuado para su inclusión en el estudio
    2. Presencia de translocación del gen de fusión de la tirosina-cinasa FIP1L1-PDGFRA u otra mutación conocida sensible a imatinib.
    3. Diagnóstico definitivo de granulomatosis eosinofílica con poliangeítis
    4. Preexistencia conocida de anomalías clínicamente significativas endocrinas, autoinmunitarias, metabólicas, neurológicas, renales, gastrointestinales, hepáticas, hematológicas, respiratorias o de cualquier otro sistema, que no estén asociadas al SHE ni controladas con el tratamiento de referencia, las cuales podrían, en opinión del investigador, poner en riesgo al paciente debido a su participación en el estudio o podrían influir en los resultados del estudio o en la capacidad del paciente para realizar el estudio por completo
    5. Hipereosinofilia de importancia desconocida
    6. Cardiovascular: antecedentes documentados de cualquier daño cardíaco clínicamente significativo, hallazgos clínicamente significativos en la ecocardiografía (si están disponibles) o el electrocardiograma (ECG) en los 12 meses anteriores a la visita 1 o hallazgos clínicamente significativos en el ECG de la selección que, en opinión del investigador, podrían poner en riesgo a los pacientes
    7. Hepatopatía conocida activa en la actualidad.
    (a) Se aceptan la hepatitis B y hepatitis C crónicas estables (incluidas las pruebas positivas para el antígeno de superficie del virus de la hepatitis B o los anticuerpos contra el virus de la hepatitis C) u otra hepatopatía crónica estable si, por lo demás, el paciente cumple los criterios de aptitud. La hepatopatía crónica estable debe definirse, en general, por la ausencia de ascitis, encefalopatía, coagulopatía,
    hipoalbuminemia, varices esofágicas o gástricas, ictericia persistente o cirrosis
    (b) Nivel de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) ≥3 veces el límite superior de la normalidad (LSN) durante la fase de selección (AST o ALT >5 × LSN si se documenta SHE con manifestaciones hepáticas). El aumento transitorio del nivel de AST/ALT que se resuelva en el momento de la aleatorización es aceptable si, en opinión del investigador, el paciente no tiene una hepatopatía activa y cumple los demás criterios de aptitud
    8. Presencia o antecedentes de neoplasia maligna, excepto:
    (a) Los pacientes que han tenido carcinoma basocelular, carcinoma epidermoide localizado o carcinoma in situ del cuello uterino son aptos siempre y cuando el paciente esté en remisión y el tratamiento curativo se haya finalizado, al menos, 12 meses antes de la fecha en la que se obtuvo el consentimiento informado y, cuando corresponda, el asentimiento
    (b) Los pacientes que han tenido otras neoplasias malignas son aptos siempre y cuando el paciente esté en remisión y el tratamiento curativo se haya finalizado, al menos, 5 años antes de la fecha en la que se obtuvo el consentimiento informado y, cuando corresponda, el asentimiento
    9. Diagnóstico de mastocitosis sistémica
    10. Infecciones activas crónicas o en curso que requieran tratamiento sistémico, así como infecciones víricas, bacterianas o fúngicas clínicamente significativas en las 4 semanas anteriores a la visita 1
    11. Una infección parasitaria helmíntica diagnosticada en las 24 semanas anteriores a la visita 1, que no haya sido tratada con el tratamiento estándar o que no haya respondido a este. Antes de la visita 1 debe estar disponible la confirmación de la resolución completa de cualquier infección parasitaria helmíntica
    12. Antecedentes de trastorno de inmunodeficiencia conocido, distinto del explicado por el uso de OCS u otro tratamiento tomado para el SHE. Resultado positivo en la prueba del virus de la inmunodeficiencia humana (VIH)

    Por favor consulte el protocolo para la lista completa de criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    Time to first HES worsening/flare
    - Population: Full analysis set
    - Intercurrent event strategy: Included in analysis regardless of treatment discontinuation (treatment policy)
    - Population-level summary: Hazard ratio
    (HES worsening/flare: HES clinical manifestations or lab abnormalities that result in an increase/burst of oral corticosteroids (OCS) ≥10 mg/day for at least 2 days OR an increase, or addition of new cytotoxic and/or immunosuppressive therapy, OR hospitalization)
    Tiempo hasta el primer empeoramiento/exacerbación del SHE
    - Población: conjunto de análisis completo
    - Estrategia de acontecimientos intercurrentes: se incluye en el análisis independientemente de la interrupción del tratamiento (política de tratamiento)
    - Resumen a nivel de población: cociente de riesgos instantáneos
    (Empeoramiento/exacerbación del SHE: Manifestaciones clínicas o anomalías de laboratorio del SHE que dan lugar a un aumento/recarga de corticosteroides orales (CCO) ≥10 mg/día durante al menos 2 días O un aumento, o adición de nueva terapia citotóxica y/o inmunosupresora, U hospitalización).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the 24wk double-blind treatment period
    A lo largo del periodo de tratamiento doble ciego de 24 semanas
    E.5.2Secondary end point(s)
    DB treatment period
    -Time to first haematologic relapse
    -Proportion of patients who experience HES worsening/flare
    -Proportion of patients who have haematologic relapse
    -Proportion of patients who have AEC<500 cells/µL for 24 weeks
    -Proportion of patients who require an increase in corticosteroid dose from baseline at any point in the double-blind treatment period
    -Fatigue questionnaire
    -Serum benralizumab concentrations, Anti-benralizumab antibodies and neutralising antibodies (nAb)
    -Safety and tolerability will be evaluated in terms of adverse events (AEs), vital signs, clinical laboratory, and electrocardiogram (ECG)

    OLE treatment period
    -Proportion of patients who experience HES worsening/flare
    -Annualized rate of HES worsening/flare
    -Fatigue questionnaire
    -Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory, and ECG
    -Serum benralizumab concentrations, anti-benralizumab antibodies and nAb
    -HES symptom questionnaire
    Periodo de tratamiento doble ciego:
    -Tiempo hasta la primera recidiva hematológica
    -Proporción de pacientes que experimentan un empeoramiento/exacerbación del SHE
    -Proporción de pacientes que presentan recidiva hematológica
    -Proporción de pacientes que tienen un RAE <500 células/μl durante 24 semanas
    -Proporción de pacientes que requieren un aumento de la dosis de corticoesteroides desde el inicio en cualquier momento del periodo de tratamiento doble ciego
    -Fatiga (Formulario)
    -Concentraciones séricas de benralizumab, Anticuerpos antibenralizumab y anticuerpos neutralizantes (Acn)
    -La seguridad y la tolerabilidad se evaluarán en términos de acontecimientos adversos (AA), constantes vitales, analíticas clínicas y electrocardiograma

    Periodo de tratamiento de extensión abierta:
    -Proporción de pacientes que experimentan un empeoramiento/exacerbación del SHE
    -Tasa anualizada de empeoramientos/exacerbaciones de SHE
    -Fatiga (Formulario)
    -La seguridad y la tolerabilidad se evaluarán en términos de AA, constantes vitales, analíticas clínicas y electrocardiograma
    -Concentraciones séricas de benralizumab, Anticuerpos antibenralizumab y Acn
    -Cuestionario de síntomas del SHE
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varies depending on the endpoint/objective
    Varía en función del objetivo final
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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 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. 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    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 final del estudio se define como la última visita/contacto previsto del último paciente sometido al estudio.
    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 months4
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days25
    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: 6
    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. of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 120
    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)
    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 Decision2023-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands