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    Summary
    EudraCT Number:2013-002345-11
    Sponsor's Protocol Code Number:D3250C00017
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-30
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase III, multicentrico, randomizzato, a gruppi paralleli, in doppio cieco, controllato verso placebo, per valutare l’efficacia e la sicurezza di Benralizumab (MEDI-563) in aggiunta ad una combinazione di corticosteroidi inalatori ad alto dosaggio e un β2-agonista a lunga durata d’ azione in pazienti con asma non controllato (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
    Studio sulla efficacia e sulla sicurezza di Benralizumab (MEDI-563) in aggiunta ad una combinazione di corticosteroidi inalatori ad alto dosaggio e un β2-agonista a lunga durata d’ azione in pazienti con asma non controllato
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 (una malattia che causa difficoltà di respirazione) non completamente controllato: con episodi di difficoltà di respirazione nonostante l'uso di altri trattamenti disponibili
    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 14.1
    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
    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
    Lo scopo di questo studio è di valutare l’effetto di due regimi di dosaggio di benralizumab sulle riacutizzazioni d’asma in pazienti adulti con asma non controllato.
    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
    Valutare l’effetto di due regimi di dosaggio di benralizumab su:
    • funzionalità polmonare
    • sintomi dell’asma e altri parametri di controllo dell’asma
    • accessi in Pronto Soccorso e ospedalizzazioni dovute all’asma
    • farmacocinetica e immunogenicità
    • Sicurezza e tollerabilità
    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.Firma del consenso informato prima di qualunque procedura specifica dello studio
    2.Maschi e femmine di età compresa tra 18 e 75 anni.
    3.Storia di asma, diagnosticata da un medico, che richiede un trattamento con una dose da media ad alta di corticosteroidi inalatori ICS (dose giornaliera totale equivalente a più di 250 μg di fluticasone in formulazione a polvere secca) e un LABA, da almeno 12 mesi prima di visita 1.
    4.Trattamento documentato con ICS ad alto dosaggio (>500 μg di fluticasone in formulazione di polvere secca) e LABA da almeno 3 mesi prima di 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, hyperventilation 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.Malattie polmonari clinicamente importanti oltre all’asma (es. infezione ai polmoni in corso, COPD, bronchiectasia, fibrosi polmonare, fibrosi cistica, sindrome dell’ipoventilazione associata ad obesità, tumore al polmone, deficit di alfa-1-antitripsina, discinesia ciliare primaria) o se sono mai state diagnosticate malattie polmonari o sistemiche, oltre all’asma, associate ad un conteggio elevato degli eosinofili periferici (es. aspergillosi/micosi broncopolmonari allergiche, sindrome di Churg-Strauss, sindrome ipereosinofilica)
    2.Qualunque disordine inclusi, ma non limitati a questi, cardiovascolare, gastrointestinale, epatico, renale, neurologico, muscolo scheletrico, infettivo, endocrino, metabolico, ematologico, psichiatrico o di indebolimento importante fisico non stabile a giudizio dello Sperimentatore e che potrebbe influire sulla sicurezza del paziente durante la partecipazione allo studio, influenzare i risultati dello studio o la loro interpretazione o impedire al paziente di portare a termine l’intera partecipazione allo studio
    3.Infezioni acute del tratto respiratorio superiore o inferiore che hanno richiesto l’uso di terapia antibiotica o antivirale nei 30 giorni precedenti la data di firma del consenso informato o durante il periodo di screening/run-in
    4.Ogni risultato anomalo clinicamente significativo che emerga all’esame fisico, nei segni vitali, in ematologia, chimica clinica o analisi delle urine durante il periodo di screening/run-in e che, a giudizio dello Sperimentatore, potrebbe mettere a rischio il paziente a causa della sua partecipazione allo studio, o potrebbe influenzare i risultati dello studio, o impedire al paziente di completare lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Annual asthma exacerbation rate
    Tasso annuale di riacutizzazioni d' asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    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.FEV1 pre-dose/ pre-broncodilatatore e FEV1 post-broncodilatatore in ospedale
    2.Punteggi relativi ai sintomi d’asma (totali, diurni, notturni), Uso di farmaci di emergenza, Funzione polmonare valutata a domicilio (mattina e sera PEF), Risvegli notturni dovuti all’asma, ACQ-6
    3.Tasso annuale di riacutizzazioni d’asma che sono associate all’accesso in Pronto Soccorso o a ospedalizzazione
    4.Parametri PK e anticorpi anti-farmaco (ADA)
    5.AE/SAE, Variabili di laboratorio, ECG, Esame fisico
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    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 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 concerned22
    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
    LPLV
    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 months10
    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 state76
    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
    studio di sicurezza a lungo termine
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-08
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