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    Summary
    EudraCT Number:2018-000170-30
    Sponsor's Protocol Code Number:D3250C00065
    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:2018-08-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000170-30
    A.3Full title of the trial
    A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients with Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid plus Long acting β2 Agonist and Chronic Oral Corticosteroid Therapy (PONENTE)
    Ensayo fase 3b, abierto, multicéntrico para evaluar la eficacia y la seguridad de benralizumab 30 mg administrado por vía subcutánea para reducir el uso de corticosteroides orales en pacientes adultos con asma grave eosinofílica en tratamiento con corticosteroides inhalados a dosis altas más un agonista β2 de acción prolongada y tratamiento crónico con corticosteroides orales (PONENTE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate efficacy and safety of Benralizumab in reducing Oral Corticosteroid use in adult patients with severe asthma.
    Estudio para evaluar la eficacia y la seguridad de Benralizumab en la reducción del uso de corticosteroides orales en pacientes adultos con asma grave.
    A.3.2Name or abbreviated title of the trial where available
    PONENTE
    PONENTE
    A.4.1Sponsor's protocol code numberD3250C00065
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03557307
    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 sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    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/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountrySweden
    B.5.4Telephone number+18772409479
    B.5.6E-mailinformation.center@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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Eosinophilic Asthma
    Asma Grave Eosinofílica
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the ability to reduce Oral Corticosteroid (OCS) dose in adult patients with severe eosinophilic asthma treated with benralizumab 30 mg Subcutaneous (SC)
    Evaluar la capacidad de reducir la dosis de Corticosteroides orales (OCS) en pacientes adultos con asma grave eosinofílica tratados con benralizumab 30 mg Subcutaneo (SC)
    E.2.2Secondary objectives of the trial
    1. To assess the sustained reduction of daily OCS dose while not losing asthma control during approximately 6 months after the end of OCS down-titration (maintenance phase) in adult patients with severe eosinophilic asthma treated with benralizumab 30 mg SC

    2. To assess the effect of OCS down titration protocol on asthma control in adult patients with severe eosinophilic asthma treated with benralizumab 30 mg SC

    3. To assess the effect of OCS down titration protocol on quality of life in adult patients with severe eosinophilic asthma treated with benralizumab 30 mg SC
    1. Evaluar la reducción mantenida de la dosis diaria de OCS sin perder el control del asma durante aproximadamente 6 meses después del final de la reducción de la dosis de OCS (fase de mantenimiento) en pacientes adultos con asma grave eosinofílica tratados con benralizumab 30 mg SC

    2. Evaluar el efecto del protocolo de reducción de los OCS en el control del asma en pacientes adultos con asma grave eosinofílica tratados con benralizumab 30 mg SC

    3. Evaluar el efecto del protocolo de reducción de los OCS en la calidad de vida en pacientes adultos con asma grave eosinofílica tratados con benralizumab 30 mg SC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A multicenter, open-label, phase 3b efficacy and safety study of Benralizumab 30 mg administered subcutaneously to reduce oral corticosteroid use in adult patients with severe eosinophilic asthma on high dose inhaled Corticosteroid plus Long-acting β2 Agonist and chronic Oral Corticosteroid therapy. version 1 (dated 12-April-2018)

    Sputum (in a subset of patients) for cell differential counts, biomarkers, and transcriptomic profiling

    Objective: To assess the effect of benralizumab on exploratory biomarkers of inflammation and asthma disease and investigate biomarkers for predicting response to benralizumab
    Ensayo fase 3b, abierto, multicéntrico para evaluar la eficacia y la seguridad de benralizumab 30 mg administrado por vía subcutánea para reducir el uso de corticosteroides orales en pacientes adultos con asma grave eosinofílica en tratamiento con corticosteroides inhalados a dosis altas más un agonista β2 de acción prolongada y tratamiento crónico con corticosteroides orales. versión 1 (de fecha 12-Abril-2018)

    Esputo (en un subgrupo de pacientes) para recuento diferencial de células, biomarcadores y perfil transcriptómico

    Objetivo: Evaluar el efecto de benralizumab en biomarcadores exploratorios de inflamación y asma e investigar biomarcadores para predecir la respuesta a benralizumab
    E.3Principal inclusion criteria
    1. Peripheral blood eosinophil count of ≥150 cells/μL assessed by central lab at Visit 1 or ≥ 300 cells/μL in the past 12 months

    2. History of physician diagnosed asthma requiring continuous treatment with high dose ICS (high-dose ICS is the highest approved dose in a country) plus LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers

    3. Chronic oral corticosteroid therapy equivalent to a daily dose of at least 5 mg of prednisone, for at least 3 continuous months directly preceding Visit 1.

    4. Patient should be on a stable OCS dose for at least 4 weeks prior to Visit 1.

    5. Non-smokers, current smokers or former smokers with a smoking history of <20 pack-years at Visit 1
    1. Los pacientes deberán presentar un recuento de eosinófilos en sangre periférica ≥ 150 células/μl según lo determinado por un laboratorio central en la visita 1 o un recuento documentado de eosinófilos ≥ 300 células/μl en los últimos 12 meses.

    2. Antecedentes de asma diagnosticado por un médico que precisen tratamiento continuo con ICS en dosis altas (ICS en dosis altas en la dosis más alta aprobada en un país) más LABA durante al menos los 6 meses previos a la Visita 1. Los ICS y LABA pueden estar en un producto combinado o administrado en inhaladores separados.

    3. Tratamiento crónico continuado de corticosteroides orales equivalente a la dosis diaria de al menos 5 mg de prednisona, durante al menos 3 meses previos a la Visita 1.

    4. Los pacientes deben estar con una dosis estable de OCS durante al menos 4 semanas antes de la visita 1.

    5. No fumadores, fumadores actuales o exfumadores con una historia como fumador de <20 paquetes al año en la Visita 1.
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts

    2. Known history of allergy or reaction to the study drug formulation

    3. History of anaphylaxis to any biologic therapy

    4. 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

    5. Asthma exacerbation requiring use of systemic corticosteroids, or an increase in maintenance dose of OCS, or acute upper/lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose)

    6. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test

    7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN) confirmed at Visit 1.

    8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained

    9. Coincident primary adrenal failure (Addison’s disease) or irreversible secondary hypoadrenalism due to another independent cause (e.g. pituitary tumour or its treatment)

    10. Co-existent inflammatory conditions for which chronic OCS doses are part of their maintenance treatment such as Giant Cell Arteritis, Polymyalgia Rheumatica

    11. Exclusion from genetic research may be for any of the exclusion criteria specified in the main study or allogeneic bone marrow transplant, Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection
    1. Enfermedad pulmonar clínicamente significativa aparte del asma o que se ha diagnosticado con una enfermedad pulmonar o sistémica, aparte del asma, que están asociadas con el recuento elevado de eosinófilos periféricos

    2. Historia conocida de alergia o reacción a la formulación de la medicación del estudio.

    3. Historia de anafilaxis a la terapia biológica

    4. Una infección parasitaria por helmintos diagnosticada en las 24 semanas anteriores a la fecha de la obtención del consentimiento informado que no ha sido tratada o ha fracasado al tratamiento estandar.

    5. Exacerbación del asma que requiere el uso de corticosteroides sistémicos, o un aumento en la dosis de manteniemiento de los OCS, o infecciones agudas respiratorias de vías altas/bajas necesitando medicación antibiótica o antiviral en los 30 días anteriores a la Visita 2 (primera dosis de benralizumab)

    6. Histórico conocido de alteración de la inmunodeficiencia incluyendo un test positivo del virus de la inmunodeficiencia humana (SIDA)

    7. Nivel de alanino aminotransferasa (ALT) o aspartato animotransferasa (AST) ≥3 veces por encima del límite normal confirmado en la Visita 1.

    8. Recibir inmunoglobulina o productos sanguíneos en los 30 días anteriores a la fecha de la obtención del consentimiento informado.

    9. Insuficiencia adrenal primaria (enfermedad de Addison) o hipoadrenalismo secundario irreversible debido a otra causa independiente (p.ej. tumor pituitario o su tratamiento).

    10. Condiciones inflamatorias co-existentes para las que las dosis crónicas de OCS son parte de su tratamiento de mantenimiento tal como Arteritis de Células Gigantes, Polimialgia Reumática

    11. La exclusión del estudio genético puede ser para cualquiera de los criterios de exclusión especificados en el estudio principal o trasplante alogénico de médula ósea, trasfusión de sangre entera no leucodepleccionada dentro de los 120 días de la recogida de la muestra genética.
    E.5 End points
    E.5.1Primary end point(s)
    1. Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma

    2. Patients who achieve 100% reduction or a daily OCS dose of ≤5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma
    1. Pacientes que logren una reducción del 100% de la dosis diaria de OCS mantenida durante al menos 4 semanas sin empeoramiento del asma

    2. Pacientes que logren una reducción del 100% o una dosis diaria de OCS ≤ 5 mg, si el motivo para no reducir más la dosis de OCS es una Insuficiencia Adrenal (IS), que se mantenga durante al menos 4 semanas sin empeoramiento del asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Visit 3 to End of OCS Reduction Phase

    2. Visit 3 to End of OCS Reduction Phase
    1. Desde la Visita 3 hasta el final de la fase de reducción de OCS

    2. Desde la Visita 3 hasta el final de la fase de reducción de OCS
    E.5.2Secondary end point(s)
    1. Patients who achieve a daily OCS dose of ≤5 mg that are sustained over at least 4 weeks without worsening of asthma

    2. Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in average daily OCS dose, sustained over at least 4 weeks without worsening of asthma

    3. Change from baseline in average daily OCS dose (mg) from start of OCS reduction to end of the OCS reduction phase
    1. Pacientes que alcancen una dosis diaria de OCS ≤ 5 mg mantenida durante al menos 4 semanas sin empeoramiento del asma

    2. Pacientes que logren una reducción ≥ 90%, ≥ 75% y ≥ 50% de la dosis diaria media de OCS, mantenida durante al menos 4 semanas sin empeoramiento del asma

    3. Variación con respecto al momento basal de la dosis diaria media de OCS (mg) desde el inicio de la reducción de los OCS hasta el final de la fase de reducción de los OCS
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Visit 3 to End of OCS Reduction Phase

    2. Visit 3 to End of OCS Reduction Phase

    3. Visit 3 to End of OCS Reduction Phase
    1. Desde la Visita 3 hasta el final de la fase de reducción de OCS

    2. Desde la Visita 3 hasta el final de la fase de reducción de OCS

    3. Desde la Visita 3 hasta el final de la fase de reducción de OCS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA83
    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
    Argentina
    Belgium
    Brazil
    Canada
    Colombia
    Denmark
    France
    Germany
    Italy
    Mexico
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    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
    LSLV.
    Última visita del último paciente
    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 months3
    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 months3
    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: 480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 249
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusOngoing
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