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    EudraCT Number:2017-001040-35
    Sponsor's Protocol Code Number:D3250C00045
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-001040-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment
    Estudio en fase IIIb, multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo, para evaluar la seguridad y la eficacia de 30 mg de benralizumab SC en pacientes con asma grave no controlada con tratamiento según la práctica clínica habitual
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of Benralizumab in Patients with Severe Asthma Uncontrolled.
    Un estudio para evaluar el efecto de Benralizumab en pacientes con asma grave no controlada.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD3250C00045
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03170271
    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 supportAstraZeneca AB
    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 AddressVastra Malarehamnen 9
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.4Telephone number+34971175440
    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.3.10 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
    severe uncontrolled asthma
    Asma grave no controlado
    E.1.1.1Medical condition in easily understood language
    Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occurring despite the use of other available treatments
    El asma (una enfermedad que causa dificultad para respirar) que no está controlada, de modo que los episodios de dificultad respiratoria ocurren a pesar del uso de otros tratamientos disponibles
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049106
    E.1.2Term Asthma chronic
    E.1.2System Organ Class 100000015470
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of benralizumab on the rate of asthma exacerbations
    Determinar el efecto del benralizumab sobre la tasa de exacerbaciones de asma
    E.2.2Secondary objectives of the trial
    To determine the effect of benralizumab on:
    - patient-reported disease-specific quality of life.
    - lung function.
    - patient-reported asthma control.
    - time to first asthma exacerbation.
    - lung function at home.
    - general quality of life and health status.
    To evaluate patient impression of overall asthma severity and change in the overall asthma status.
    To determine the effect of benralizumab on the patient’s predominant symptoms and disease specific health-related quality of life in patients with doctor diagnosed chronic sinusitis with nasal polyposis.
    Safety Objective: To assess the safety and tolerability of benralizumab
    Exploratory Objectives:
    To determine the effect of:
    -eosinophil depletion with benralizumab on Biomarker components of known asthma inflammatory pathways or airway remodeling and Biomarker surrogates of eosinophilic inflammation/activation
    -benralizumab on the patient’s level of asthma control based standard asthma guidance recommendations
    Determinar el efecto del benralizumab en: -calidad de vida específica de la enfermedad notificada por el paciente.-función pulmonar. -control del asma notificado por el paciente.-tiempo hasta la primera exacerbación del asma.-la función pulmonar en el domicilio.-la calidad de vida y el estado de salud general.
    Evaluar impresión del paciente sobre la gravedad general del asma. Determinar el efecto del benralizumab sobre la calidad de vida relacionada con la salud específica de la enfermedad en pacientes con sinusitis crónica con poliposis nasal diagnosticada por un médico.
    Objetivo seguridad: Evaluar la seguridad y la tolerabilidad del benralizumab.
    Objetivos exploratorios. Determinar efecto en:-reducción de eosinófilos con el benralizumab en biomarcadores de las vías inflamatorias conocidas del asma o remodelación de las vías respiratorias de la inflamación/activación eosinofílica -benralizumab en nivel de control del asma del paciente según las recomendaciones estándares de la guía
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines.
    2.Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS plus asthma controller, for at least 12 months prior to Visit 1. Other acceptable asthma controllers include a long acting bronchodilator (LABA or long-acting muscarinic antagonists [LAMA]), a leukotriene inhibitor, theophylline preparations or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent).
    3.Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1; see inclusion criterion 2 for acceptable other asthma controllers.
     For ICS/LABA combination preparations, highest-strength maintenance doses approved in the given country will meet this criterion.
     If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose.
    4.History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of their maintenance dose.
    5.ACQ6 score ≥1.5 at Visit 1.
    6.Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2
    Note: Spirometry testing should only be performed if the patient meets the asthma medication hold for lung function testing (see Section 3.10.2), the test should be postponed to another day prior to Visit 3 to improve the chances of achieving a qualifying FEV1 that is not affected by bronchodilator medication.
    7.Evidence of asthma as documented by airway reversibility (FEV1 ≥12%) demonstrated at Visit 2 or Visit 3.
    8.Peripheral blood eosinophil count of ≥300 cells/μL assessed by central laboratory at Visit 1 or Visit 2.
    9.Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the Investigator), eg, total sexual abstinence when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception), a vasectomized sexual partner, Implanon®, female sterilization by tubal occlusion, any effective Intrauterine device/Levonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™ or Nuvaring™. Women of childbearing potential must agree to use birth control, as defined above, from enrolment, throughout the study duration and until 16 weeks (approximately 5 half-lives) after last dose of investigational product (IP). Women of childbearing potential must also have negative serum pregnancy test result on Visit 1.
    10.Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age specific requirements apply:
     Women <50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range.
     Women ≥50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
    11.All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
    12.Weight of ≥40 kg.
    1.El consentimiento informado por escrito para la participación en el estudio se debe obtener antes de cualquier procedimientos relacionado con el Ensayo que se están realizando y de acuerdo con las directrices internacionales y / o directrices aplicables de la Unión Europea (UE).
    2. Pacientes mujeres y varones de 18 a 75 años de edad inclusivamente en el momento de la Visita 1 con antecedentes de asma diagnosticada por un médico que requiera tratamiento con ICS de media a alta dosis y controlador de asma durante al menos 12 meses antes de la Visita 1. Otros controladores de asma aceptados incluyen un broncodilatador de acción prolongada (LABA o antagonistas muscarínicos de larga duración [LAMA]), un inhibidor de leucotrieno, preparaciones de teofilina o mantenimiento OCS (diariamente o cada dos días para mantener el control del asma, 20 mg de prednisona o equivalente).
    3. Tratamiento actual con dosis diarias altas de ICS más al menos otro controlador de asma durante al menos 3 meses antes de la Visita 1; Vea el criterio de inclusión 2 para otros controladores de asma aceptables.
    - Para las preparaciones combinadas ICS / LABA, las dosis de mantenimiento de mayor resistencia aprobadas en el país.
     Si el ICS y las otras terapias de control de asma son administradas por inhaladores separados, entonces el paciente debe estar en una dosis diaria alta de ICS.
    4.Historia de por lo menos 2 exacerbaciones de asma mientras ICS más otro controlador de asma (véase el criterio de inclusión 2 para los ejemplos) que requirió tratamiento con corticosteroides sistémicos (IM, IV u oral) en los 12 meses previos a la Visita 1. Para los pacientes que reciben Corticosteroides como terapia de mantenimiento, el tratamiento con corticosteroides para la exacerbación se define como un aumento temporal de su dosis de mantenimiento.
    5.ACQ6 ≥1.5 en la Visita 1.
    6.Selección de FEV1 pre-broncodilatador (pre-BD) <80% predicho en la Visita 2. Nota: La prueba de espirometría sólo debe realizarse si el paciente cumple con la suspensión del medicamento para el asma para la prueba de la función pulmonar (ver Sección 3.10.2), la prueba debe posponerse a otro día antes de la Visita 3 para mejorar las posibilidades de lograr un VEF1 calificado que No se ve afectada por la medicación broncodilatadora.
    7.Evidencia de asma documentada por la reversibilidad de las vías respiratorias (FEV1 ≥ 12%) demostrado en la Visita 2 o Visita 3.
    8.Integración de eosinófilos en sangre periférica de ≥300 células / μl evaluada por el laboratorio central en la Visita 1 o Visita 2.
    9. Las mujeres en edad fértil (WOCBP) deben utilizar una forma eficaz de control de la natalidad (confirmada por el investigador), por ejemplo, la abstinencia sexual total cuando ésta está en consonancia con el estilo de vida preferido y habitual del paciente (abstinencia periódica [ , Ovulación, sintotérmica, métodos post-ovulación] y retiro no son métodos aceptables de anticoncepción), una pareja sexual vasectomizada, Implanon®, esterilización femenina por oclusión tubárica, cualquier dispositivo Intrauterino efectivo / Levonorgestrel intrauterino, inyecciones Depo-Provera ™, oral Anticonceptivos y Evra Patch ™ o Nuvaring ™. Las mujeres en edad fértil deben acordar el uso de anticonceptivos, como se definió anteriormente, de la inscripción, durante la duración del estudio y hasta 16 semanas (aproximadamente 5 medias vidas) después de la última dosis del producto de investigación. Las mujeres en edad fértil también deben tener resultados negativos en la prueba de embarazo de suero en la Visita 1.
    10. Las mujeres que no tienen potencial para procrear se definen como mujeres que están permanentemente esterilizadas (histerectomía, ooforectomía bilateral o salpingectomía bilateral) o posmenopáusicas. Las mujeres se considerarán posmenopáusicas si han sido amenorreicas durante 12 meses antes de la fecha prevista de la asignación al azar sin una causa médica alternativa. Se aplican los siguientes requisitos específicos de edad:
     Las mujeres <50 años de edad se consideran posmenopáusicas si han sido amenorreicas durante 12 meses o más después del cese del tratamiento hormonal exógeno y si los niveles de hormona folículo estimulante (FSH) están en el intervalo posmenopáusico.
     Las mujeres mayores de 50 años se consideran posmenopáusicas si han sido amenorreicas durante 12 meses o más después del cese de todo tratamiento hormonal exógeno.
    11. Todos los pacientes varones que son sexualmente activos deben acordar usar un método de anticoncepción de doble barrera (condón con espermicida) desde la primera dosis de IP hasta 16 semanas después de su última dosis.
    12.Peso de ≥ 40 kg.
    E.4Principal exclusion criteria
    1.Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease [COPD], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
    2.Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
    3.Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
    Affect the safety of the patient throughout the study.
    Influence the findings of the studies or their interpretations.
    Impede the patient’s ability to complete the entire duration of study.
    4.Known history of allergy or reaction to any component of the IP formulation.
    5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
    6.Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, 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 entire duration of the study.
    7.Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments.
    8.History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
    9.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
    10.Current smokers or former smokers with a smoking history of ≥10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1.
    11.Current malignancy, or history of malignancy, except for:
    Patients who have had non-melanoma skin cancers or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent is obtained.
    Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent is obtained.
    12.Approved or off-label use of systemic immunosuppressive medications within 3 months prior to the date informed consent is obtained. These include but are not limited to small molecules such as methotrexate, cyclosporine, azathioprine, and immunosuppressive/immunomodulating biologics such as tumor necrosis factor (TNF) blockers. Regular use of systemic (oral) corticosteroids is also excluded except for the indication of asthma.
    13.Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of Visit 1). Acceptable washout periods for other asthma biologics: Other eosinophil lowering products indicated for asthma (including mepolizumab or reslizumab): at least 4 months.Prior omalizumab use: at least 1 month.
    14.Previously received benralizumab (MEDI-563).
    15.Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization.
    16.ALT or AST level >3 times the upper limit of normal (ULN) confirmed during screening period.
    17.Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
    18.Receipt of live attenuated vaccines 30 days prior to the date of randomization; other types of vaccines are allowed.
    19.Planned surgical procedures during the conduct of the study.
    20.Currently breastfeeding or lactating women.
    21.Pevious randomization in the present study.
    22.Concurrent enrolment in another interventional or post-authorization safety study.
    23.AstraZeneca staff involved in the planning and/or conduct of the study.
    24.Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals.
    1. Enfermedad pulmonar de importancia clínica distinta del asma (infección pulmonar activa, enfermedad pulmonar obstructiva crónica [EPOC], bronquiectasia, fibrosis pulmonar, fibrosis quística, etc), o alguna enfermedad pulmonar o sistémica diagnosticada distinta del asma, con recuentos elevados de eosinófilos periféricos (aspergilosis broncopulmonar / micosis alérgica, síndrome de Churg-Strauss, síndrome hipereosinofílico, etc).
    2. Infecciones respiratorias superiores o bajas agudas dentro de los 30 días previos a la fecha en que se obtiene el consentimiento informado o durante el período de detección / ejecución.
    3. Cualquier trastorno, incluyendo, pero no limitado a, trastornos cardiovasculares, gastrointestinales, hepáticos, renales, neurológicos, músculo-esqueléticos, infecciosos, endocrinos, metabólicos, hematológicos, psiquiátricos o físicos mayores que no son estables a juicio del investigador y que podrían: Afectar la seguridad del paciente, Influir en los resultados de los estudios o sus interpretaciones, Impedir la capacidad del paciente para completar el estudio.
    4. Historia conocida de alergia o reacción a cualquier componente de la formulación.
    5. Infección parasitaria de helmintos diagnosticada en las 24 semanas previas a la fecha en que se obtiene el CI que no ha sido tratada o no ha respondido al tratamiento estándar.
    6. Hallazgos anormales clínicamente significativos en el examen físico, los signos vitales, la hematología o la química clínica durante el período de cribado, que en opinión del investigador pueden poner al paciente en riesgo debido a su participación en el estudio, o pueden influir en el Resultados del estudio, o la capacidad del paciente para completar el estudio.
    7. Enfermedad cardíaca clínicamente significativa o cualquier anomalía de electrocardiograma (ECG) obtenida durante el período de detección / evaluación que, en opinión del investigador, puede poner al paciente en riesgo o interferir en las evaluaciones del estudio.
    8.Historia de abuso de alcohol o drogas dentro de los 12 meses anteriores a la fecha de obtención de CI.
    9. Antecedentes de trastornos de inmunodeficiencia conocidos que incluyen una prueba positiva del virus de la inmunodeficiencia humana (VIH).
    10.Fumadores actuales o ex fumadores con antecedentes de tabaquismo de ≥ 10 años de paquetes. Un ex fumador se define como un paciente que deja de fumar al menos 6 meses antes de la Visita 1.
    11.Cáncer maligno actual o antecedentes de malignidad, excepto por:
    Los pacientes que han tenido cáncer de piel no melanoma o carcinoma in situ del cuello uterino son elegibles siempre que el paciente esté en remisión y la terapia curativa haya sido completada al menos 12 meses antes de la fecha en que se obtiene el CI.
    Los pacientes que han tenido otras neoplasias malignas son elegibles siempre que el paciente esté en remisión y la terapia curativa haya sido completada al menos 5 años antes de la fecha en que se obtenga el CI.
    12. Se ha aprobado el uso de medicamentos inmunosupresores sistémicos en los 3 meses anteriores a la fecha en que se obtuvo el consentimiento informado. Estos incluyen, pero no se limitan a, moléculas pequeñas tales como metotrexato, ciclosporina, azatioprina, e inmunosupresores / inmunomoduladores biológicos tales como bloqueadores del factor de necrosis tumoral (TNF). También se excluye el uso regular de corticosteroides sistémicos (orales), excepto para la indicación de asma.
    13.Los productos biológicos concurrentes para el asma no están permitidos, excepto para la inmunoterapia con alergenos estables (definida como una dosis y un régimen estable en el momento de la visita 1). Períodos de lavado aceptables para otros productos biológicos del asma: Otros productos reductores de eosinófilos indicados para el asma (incluyendo mepolizumab o reslizumab): al menos 4 meses. Uso de omalizumab superior: al menos 1 mes.
    14. Previamente recibió benralizumab (MEDI-563).
    15. Recepción de cualquier medicamento de investigación como parte de un estudio de investigación dentro de aproximadamente 5 vidas medias antes de la aleatorización.
    16.ALT o nivel de AST> 3 veces el límite superior de la normalidad (ULN) confirmado durante el período de cribado.
    17.Recepción de inmunoglobulina o productos sanguíneos dentro de los 30 días previos a la fecha en que se obtiene el consentimiento informado.
    18.Recepción de vacunas vivas atenuadas 30 días antes de la fecha de la asignación al azar; Se permiten otros tipos de vacunas.
    19. Procedimientos quirúrgicos planificados durante la realización del estudio.
    20.Actualmente lactantes o lactantes.
    21.Previa randomización en el presente estudio.
    22.Inscripción concurrente en otro estudio de seguridad intervencional o post autorización.
    23. Personal AstraZeneca involucrado en la planificación y / o realización del estudio.
    24. Empleados del centro de estudio o cualquier otra persona involucrada en la realización del estudio o miembros de la familia
    E.5 End points
    E.5.1Primary end point(s)
    The annualized rate of asthma exacerbations between benralizumab and placebo.
    La tasa de anulidad de exacerbaciones de asma entre benralizumab y placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment period of 24 weeks.
    Periodo de tratamiento de 24 semanas.
    E.5.2Secondary end point(s)
    The change from baseline (Visit 4) in Saint George Respiratory Questionnaire (SGRQ) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in forced expiratory volume in first second (FEV1) over the treatment period (up to and including Day 168/Week 24).
    The change from baseline (Visit 4) in Asthma Control Questionnaire 6 (ACQ6) to the EOT (Day 168/Week 24).
    Time to first asthma exacerbation (treatment period 24 weeks).
    The change from run-in baseline morning peak expiratory flow (PEF) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) SF 36v2 to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in PGI-S to the EOT (Day 168/Week 24).
    The degree of change reported by the patient (PGI-C) and Investigator (CGI-C) expressed as a proportion of each of the 7 possible responses to the EOT (Day 168/Week 24).
    The degree of change reported by the patient in their predominant symptom to the EOT (Day 168/Week 24).
    The change from baseline (Visit 3) in the sino-nasal outcome test (SNOT-22) score to the EOT (Day 168/Week 24).
    Safety: Adverse events (AEs), laboratory variables, physical examination.
    The change from baseline (Visit 4) in circulating biomarkers to each pre-specified scheduled assessment during the treatment period.
    The proportion of time that that the patient’s asthma is well-controlled based on composite diary measures.
    El cambio desde el inicio (visita 4) en el Cuestionario respiratorio de Saint George (CRSG) hasta el final del tratamiento (FDT, día 168/semana 24).
    El cambio desde el inicio (visita 4) en el volumen espiratorio forzado en el primer segundo (VEF1) durante el periodo de tratamiento (hasta el día 168/la semana 24, inclusive).El cambio en el cuestionario de control del asma 6 (Asthma Control Questionnaire 6, ACQ6) desde el inicio (visita 4) hasta el FDT (día 168/semana 24).
    Tiempo hasta la primera exacerbación del asma (periodo de tratamiento de 24 semanas).
    El cambio en el flujo espiratorio máximo (FEM) de la mañana desde el inicio de la preinclusión hasta el FDT (día 168/semana 24).
    El cambio en el SF-36v2 desde el inicio (visita 4) hasta el FDT (día 168/semana 24).
    El cambio en la PGI-S desde el inicio (visita 4) hasta el FDT (día 168/semana 24).
    La magnitud del cambio notificado por el paciente (PGI-C) y el investigador (CGI-C), expresado como una proporción de cada una de las 7 posibles respuestas, hasta el FDT (día 168/semana 24).
    La magnitud del cambio notificado por el paciente en su síntoma predominante hasta el FDT (día 168/semana 24).
    El cambio en la puntuación de la prueba de resultados sinonasales (sino-nasal outcome test, SNOT-22) desde el inicio (visita 3) hasta el FDT (día 168/semana 24).
    Seguridad: Acontecimientos adversos (AA), variables de laboratorio, exploración física.
    Exploratorio: El cambio en los biomarcadores circulantes desde el inicio (visita 4) hasta cada evaluación programada preespecificada durante el periodo de tratamiento.
    La proporción de tiempo que el asma del paciente está bien controlada según las medidas compuestas del diario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline (Visit 4) to EOT (Day 168/ Week 24).
    Throughout 24 week treatment period.
    Desde la línea de base (Visita 4) a EOT (Día 168 / Semana 24).
    Durante todo el período de tratamiento de 24 semanas.
    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 No
    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
    Exploratory Biomarkers.
    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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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 Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last visit of the last patient undergoing the study’. The final study visit will be the telephone FU Visit.
    La última visita del último paciente sometido al estudio. La visita de estudio final será la visita telefónica de FU.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 720
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 373
    F.4.2.2In the whole clinical trial 800
    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)
    See protocol. Patient will return to Standard of Care.
    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 Decision2017-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-21
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