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    Summary
    EudraCT Number:2013-002345-11
    Sponsor's Protocol Code Number:D3250C00017
    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:2013-10-08
    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 number2013-002345-11
    A.3Full title of the trial
    A multicentre, randomised, double-blind, parallel group, placebo-controlled, Phase III efficacy and safety study of benralizumab (MEDI-563) added to high-dose inhaled corticosteroid plus long-acting beta2 agonist in patients with uncontrolled asthma (SIROCCO)
    Ensayo fase III, multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de Benralizumab (MEDI-563) añadido a corticosteroides inhalados a dosis altas más agonistas ?2 de acción larga en pacientes con asma no controlada (SIROCCO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of benralizumab added to high-dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma
    Ensayo para evaluar la eficacia y la seguridad de Benralizumab (añadido a corticosteroides inhalados a dosis altas más LABA en pacientes con asma no controlada (SIROCCO)
    A.3.2Name or abbreviated title of the trial where available
    SIROCCO
    SIROCCO
    A.4.1Sponsor's protocol code numberD3250C00017
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/126/2013
    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 pointAZ Clinical Study Information
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen 9
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number46855326000
    B.5.5Fax number46855329000
    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 infusion 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.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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    Asthma
    Asma
    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 occuring despite the use of other available treatments
    Asma (enfermedad causa dificultad respiratoria) no completamente controlado, por lo que esos episodios de dificultad respiratoria continuan ocurriendo pese utilizar 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 16.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to evaluate the effect of two dosing regimens of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma
    Evaluar el efecto de dos pautas posológicas de benralizumab sobre las reagudizaciones del asma en pacientes adultos con asma no controlado
    E.2.2Secondary objectives of the trial
    To assess the effect of two dosing regimens of benralizumab on:
    Pulmonary function
    Asthma symptoms and other asthma control metrics
    Emergency room visits and hospitalisations due to asthma
    Pharmacokinetics and immunogenicity
    Safety and tolerability
    Evaluar el efecto de dos pautas posológicas de benralizumab sobre:
    La unción pulmonar,
    Los síntomas de asma y otros indicadores de control y otros parámetros asociados a las reagudizaciones del asma,
    La calidad de vida relacionada con el asma y relacionada con la salud en general,
    Las visitas al servicio de urgencias y las hospitalizaciones debidas al asma, la utilización de recursos sanitarios y la pérdida de productividad debido al asma,
    Farmacocinética y la inmunogenicidad de dos pautas posológicas de benralizumab,
    Seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Female and male aged 18 to 75 years inclusively 3. History of physician diagnosed asthma requiring treatment with medium to high dose inhaled corticosteroids (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 12 months prior to visit 1
    4. Documented treatment with high dose inhaled corticosteroids (greater than 500 microgrammes fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 months prior to visit 1
    1.Otorgar el consentimiento informado con anterioridad a la realización de cualquiera de los procedimientos específicos del ensayo
    2.Mujeres y varones de 18 a 75 años, inclusive 3.Antecedentes de asma diagnosticado por un médico que requiere tratamiento con una dosis de intermedia a alta de ICS y un LABA, durante al menos 12 meses antes de la visita 1 4.Tratamiento documentado con una dosis alta de ICS (dosis diaria total equivalente a >500 µg de la formulación de fluticasona en polvo seco) y un LABA, durante al menos 3 meses antes de la visita 1
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than asthma (e.g active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliarydyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
    2. Any disorder including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairement 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 study or their interpretations, or impede the patients ability to complete the entire duration of study.
    3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run in period.
    4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry or urinalysis during screening/run in 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 patients ability to complete the entire duration of the study.
    1.Otra enfermedad pulmonar clínicamente importante aparte del asma (p. ej., neumonía activa, EPOC, bronquiectasias, fibrosis pulmonar, fibrosis quística, síndrome de hipoventilación por obesidad, cáncer de pulmón, deficiencia de alfa 1 antitripsina y discinesia ciliar primaria) o haber sido diagnosticado alguna vez de una enfermedad pulmonar o sistémica, aparte del asma, que se asocie a una cifra elevada de eosinófilos (p.ej:aspergilosis/micosis broncopulmonar alérgica, síndrome de Churg-Strauss y síndrome hipereosinofílico)
    2.Cualquier trastorno, entre otros: cardiovascular, gastrointestinal, hepático, renal, neurológico, musculoesquelético, infeccioso, endocrino, metabólico, hematológico, psiquiátrico, o deterioro físico importante que no se encuentre estable en la opinión del investigador y que pudiera:
    Afectar a la seguridad del paciente durante el ensayo
    Influir en los resultados de los estudios o en su interpretación
    Impedir que el paciente pueda completar toda la duración del ensayo
    3.Infecciones agudas de las vías respiratorias altas o bajas que haya precisado antibióticos o antivíricos en los 30 días anteriores a la fecha de obtención del consentimiento informado o durante el período de selección/preinclusión
    4.Cualquier resultado anómalo clínicamente significativo en la exploración física, constantes vitales, hematología, bioquímica o análisis de orina durante el período de selección/preinclusión que, en la opinión del investigador, pudiera suponer un riesgo para el paciente debido a su participación en el ensayo o influir en los resultados del ensayo o en la capacidad del paciente para completar toda la duración del ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Annual asthma exacerbation rate
    Tasa anual de exarcebación del asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 semanas
    E.5.2Secondary end point(s)
    1. Pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1 at the study centre
    2. Asthma symptom score (total, daytime and night time), rescue medication use, home lung function (morning and evening PEF), nights with awakening due to asthma, ACQ-6
    3. Annual rate of exacerbations associated with an emergency room visit or hospitalisation
    4. PK parameters and anti-drug antibodies
    5. AE/SAE, laboratory variables, ECG, physical examination
    1. Antes de la dosis/ Antes de medir el Volumen espiratorio forzado en un segundo (FEV1) con el broncodilatador y después de medir el FEV1 con el broncodilatador en el centro
    2. Medición de síntomas de asma (total, durante el día y la noche), el uso de medicación de rescate, la función pulmonar en casa (por la mañana y el FEM vespertino), noches con despertar debido al asma, ACQ-6
    3.Tasa anual de exacerbaciones asociadas con una visita urgencias o a una hospitalización
    4. Parámetros farmacocinéticos y los anticuerpos anti-fármaco
    5. AA / AAG, variables de laboratorio, ECG, examen físico
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 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 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 Yes
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Australia
    Brazil
    Bulgaria
    Czech Republic
    France
    Italy
    Korea, Republic of
    Mexico
    Peru
    Russian Federation
    South Africa
    Spain
    Turkey
    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
    LPLV
    Última visita del último paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1077
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 281
    F.4.2.2In the whole clinical trial 1134
    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)
    Long term safety study
    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 Decision2013-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-05
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