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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2014-001086-27
    Sponsor's Protocol Code Number:D3250C00021
    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:2015-02-25
    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 number2014-001086-27
    A.3Full title of the trial
    A Multicentre, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting ?2 Agonist (BORA)
    Ensayo de extensión de seguridad fase III, multicéntrico, aleatorizado, de grupos paralelos, para evaluar la seguridad y tolerabilidad de benralizumab (MEDI-563) en adultos y adolescentes asmáticos con un corticosteroide inhalado más un agonista ?2 de acción larga (BORA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
    Ensayo de extensión para evaluar la seguridad y tolerabilidad de benralizumab (MEDI-563) en adultos y adolescentes asmáticos con un corticosteroide inhalado más un agonista ?2 de acción larga
    A.3.2Name or abbreviated title of the trial where available
    BORA
    A.4.1Sponsor's protocol code numberD3250C00021
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/020/2014
    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 Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namebenralizumab
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive namebenralizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 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 que causa dificultad para respirar) no está totalmente controlada, por lo que los episodios de dificultad respiratoria aún se producen a pesar del uso de otros ttos. 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 17.1
    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
    To assess the safety and tolerability of two dosing regimens of benralizumab for adult and adolescent patients.
    Evaluar la seguridad y tolerabilidad de 2 pautas posológicas de benralizumab en pacientes adultos y pacientes adolescentes
    E.2.2Secondary objectives of the trial
    1.To evaluate the effect of two dosing regimens of benralizumab on asthma exacerbations.
    2.To evaluate the effect of two dosing regimens of benralizumab on health care utilization and work and productivity loss.
    3.To assess the effect of two dosing regimens of benralizumab on asthma related and general health-related quality of life.
    4.To assess the effect two dosing regimens of benralizumab on asthma control.
    5.To evaluate the pharmacokinetics and immunogenicity of two dosing regimens of benralizumab.
    6.To assess the effect of two dosing regimens of benralizumab on pulmonary function.
    7.To assess the impact of two dosing regimens of benralizumab on blood eosinophil levels.
    8.To evaluate the effect of two dosing regimens of benralizumab on concomitant asthma controller medications.
    1. Evaluar el efecto de 2 pautas posológicas de benralizumab sobre las exacerbaciones del asma.
    2. Evaluar el efecto de dos pautas posológicas de benralizumab sobre la utilización de recursos sanitarios, la actividad laboral y la pérdida de productividad laboral
    3. Evaluar el efecto de 2 pautas posológicas de benralizumab sobre la calidad de vida relacionada con el asma y la salud general
    4. Evaluar el efecto de dos pautas posológicas de benralizumab sobre el control del asma
    5. Evaluar la farmacocinética e inmunogenicidad de 2 pautas posológicas de benralizumab
    6. Evaluar el efecto de 2 pautas posológicas de benralizumab sobre la función pulmonar
    7. Evaluar el impacto de 2 pautas posológicas de benralizumab sobre los niveles sanguíneos de eosinófilos
    8. Evaluar el efecto de dos pautas posológicas de benralizumab sobre las medicaciones concomitantes para el control del asma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
    2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
    3. Women of childbearing potential (WOCBP) must agree to use a highly effective form of birth control throughout the study duration and for 16 weeks after the last dose of Invesigational Product (IP)
    4. For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
    5. All male patients who are sexually active must agree to use a method of contraception from the first dose of IP until 16 weeks after their last dose. The method of contraception must be consistent with local regulations, but at a minimum is to use a condom during sexual intercourse.
    1. Otorgar el consentimiento informado (y/o asentimiento según proceda localmente) para la participación en el ensayo antes de la realización de cualquier procedimiento relacionado con el ensayo (se debe seguir la normativa local a la hora de determinar los requisitos en cuanto asentimiento/consentimiento para niños y padre(s)/tutor(es)) y en conformidad con las directrices internacionales y/o las directrices aplicables en la Unión Europea.
    2. Los pacientes hombres y mujeres que hayan completado el período de tratamiento en doble ciego con benralizumab o placebo equiparable en doble ciego en un ensayo predecesor.
    3. Las mujeres potencialmente fértiles (MF) deben utilizar un método anticonceptivo muy eficaz durante toda la duración del ensayo y durante 16 semanas después de la última dosis del PI.
    4. Solo en mujeres potencialmente fértiles: Tener un resultado negativo en una prueba de embarazo antes de la administración del PI en la visita 1.
    5. Todos los pacientes varones que sean sexualmente activos deben aceptar utilizar un método anticonceptivo de doble barrera (preservativo con espermicida) desde la primera dosis del PI hasta 16 semanas después de su última dosis.
    E.4Principal exclusion criteria
    1.Any disorder including but not limited to pulmonary, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, 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
    2.A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
    3.Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study 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 interfere with the patient?s ability to complete the entire duration of the study
    4.Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
    1. Cualquier trastorno, como por ejemplo: pulmonar, 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
    2. Infección parasitaria helmíntica diagnosticada durante el ensayo predecesor que no haya sido tratada, haya sido incompletamente tratada o no haya respondido al tratamiento de referencia
    3. Cualquier cambio clínicamente significativo en la exploración física, constantes vitales, ECG, hematología, bioquímica o análisis de orina durante el ensayo predecesor 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
    4. Tumor maligno actual o tumor maligno desarrollado durante un ensayo predecesor (no se excluirán a aquellos pacientes con carcinoma basocelular, carcinoma de células escamosas localizado de la piel resecado para curación o carcinoma in situ de cérvix que se hayan tratado/curado).
    E.5 End points
    E.5.1Primary end point(s)
    - Number of Adverse Events/Serious Adverse Events (AEs/SAEs)
    - Laboratory variables
    - Electrocardiogram (ECG)
    - Physical Examination
    - Número de AA y AAG
    - Variables de laboratorio
    - ECG
    - Exploración física
    E.5.1.1Timepoint(s) of evaluation of this end point
    56 weeks in adult patients
    108 weeks in adolescent patients
    56 semanas en pacientes adultos
    108 semanas en pacientes adolescentes
    E.5.2Secondary end point(s)
    - Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
    - Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions (WPAI+CIQ)
    - Hospitalizations, Emergency Department (ED) visits, urgent care visits and all other outpatient visits due to asthma
    - Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12)
    - European Quality of Life-5 Dimensions (EQ-5D-5L) questionnaire
    - Asthma Control Questionnaire 6 (ACQ-6)
    - Pharmacokinetic (PK) parameters
    - Anti-drug antibodies (ADA)
    - Pre-bronchodilator Forced expiratory volume in 1 second (FEV1) and post-bronchodilator FEV1 at the study centre
    - Blood eosinophils
    - Total daily inhaled steroid dose
    - Number of other daily asthma controller medications
    - Tasa anual de exacerbaciones del asma, donde una exacerbación del asma se define como un empeoramiento del asma que requiere el uso de corticosteroides sistémicos durante al menos 3 días y/o la hospitalización y/o visita al servicio de urgencias/urgencias ambulatorias.
    - WPAI+CIQ
    - Hospitalizaciones, visitas al servicio de urgencias, visitas a urgencias ambulatorias y todas las visitas ambulatorias debidas al asma
    - AQLQ(S)+12
    - EQ-5D-5L
    - ACQ-6
    - Parámetros FC
    - Anticuerpos contra el fármaco (ACF)
    - FEV1 antes del broncodilatador y FEV1 después del broncodilatador en el centro del ensayo
    - Eosinófilos en sangre
    - Dosis diaria total de esteroide inhalado
    - Número de otras medicaciones concomitantes diarias para el control del asma
    E.5.2.1Timepoint(s) of evaluation of this end point
    56 weeks in adult patients
    108 weeks in adolescent patients
    56 semanas en pacientes adultos
    108 semanas en pacientes adolescentes
    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 No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Estudio abierto para adolescentes de la UE
    Open study for EU adolescents
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA236
    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
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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 Yes
    F.1.1Number of subjects for this age range: 158
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 158
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2315
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 77
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 996
    F.4.2.2In the whole clinical trial 2550
    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
    Ninguno
    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 Decision2014-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-02
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