Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42891   clinical trials with a EudraCT protocol, of which   7066   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001832-77
    Sponsor's Protocol Code Number:D3253C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial 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 number2019-001832-77
    A.3Full title of the trial
    A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy
    Studio randomizzato, in doppio cieco, con controllo attivo, di 52 settimane con un’estensione in aperto, volto a valutare l’efficacia e la sicurezza di benralizumab rispetto a mepolizumab nel trattamento della granulomatosi eosinofila con poliangioite (EGPA) in pazienti che ricevono la terapia standard.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if benralizumab compared to mepolizumab may be beneficial in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).
    Studio per valutare se Benralizumab in confronto a Mepolizumab possa essere di beneficio per il trattamento della Granulomatosi Eosinifila con Poliangioite (EGPA).
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberD3253C00001
    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 organisationAstraZenecaAB
    B.5.2Functional name of contact pointInformation center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE-151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name NUCALA
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1116
    D.3 Description of the IMP
    D.3.1Product namemepolizumab
    D.3.2Product code [L04AC06]
    D.3.4Pharmaceutical form Powder for solution for infusion
    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 INNMepolizumab
    D.3.9.1CAS number 0196078-29-2
    D.3.9.2Current sponsor codeMepolizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.IMP: 2
    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
    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 milligram(s)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Eosinophilic Granulomatosis with Polyangiitis (EGPA)
    Granulomatosi Eosinofila con poliangioite (EGPA)
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Granulomatosis with Polyangiitis (EGPA)
    Granulomatosi Eosinofila con poliangioite (EGPA)
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10014957
    E.1.2Term Eosinophilic granulomatous vasculitis
    E.1.2System Organ Class 100000004870
    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 durability of response to treatment with benralizumab compared with mepolizumab in patients with relapsing or refractory EGPA who are receiving Standard of Care Therapy, assessed by the proportion of patients in remission at both Weeks 36 and 48.
    Valutare la durata della risposta al trattamento con benralizumab rispetto a mepolizumab in pazienti con EGPA recidivante o refrattaria che ricevono terapia standard di cura, valutata dalla proporzione di pazienti in remissione sia alla Settimana 36 che alla Settimana 48
    E.2.2Secondary objectives of the trial
    DB
    To assess the efficacy of benralizumab compared with mepolizumab on duration of clinical remission
    To assess the efficacy of benralizumab compared with mepolizumab on time to first relapse
    To assess the average daily dose of corticosteroid from wk 48 to 52 in benralizumab compared to mepolizumab group
    To assess the annualized relapse rate in benralizumab compared to mepolizumab group
    To assess the proportion of patients achieving remission within the first 24 wks and remain in remission for the remainder of the DBperiod in benralizumab compared to mepolizumab groupd
    To assess additional measures of efficacy and health status/healthrelated quality of life in patients receiving benralizumab compared to mepolizumab
    To assess the safety,tolerability and immunogeniccity of benralizumab compared to mepolizumab
    To assess the pharmacokinetics of benralizumab

    OLE
    To evaluate the effect of benralizumab on remission, relapse and OCS use
    To assess the safety and tolerability of benralizumab
    DOPPIO-CIECO DB
    Valutare:
    -efficacia di benralizumab rispetto a mepolizumab nella durata remissione clinica
    -efficacia di benralizumab rispetto a mepolizumab per il tempo alla prima recidiva
    -dose giornaliera media di corticosterodi durante le sett da 48 a 52 nei pazienti che ricevono benralizumab rispetto a mepolizumab
    -tasso di recidiva annualizzato nei pazienti che ricevono benralizumab rispetto a mepolizumab
    -proporzione di pazienti in remissione entro le prime 24 sett e restano in remissione per il periodo DB nei pazienti che ricevono benralizumab rispetto a mepolizumab
    -misure aggiuntive di efficacia e stato di salute/ qualità della vita correlata alla salute nei pazienti che ricevono benralizumab rispetto a mepolizumab
    -sicurezza, tollerabilità e immunogenicità di benralizumab rispetto a mepolizumab
    -farmacocinetica di benralizumab
    OPEN LABEL
    Valutare:
    - l’effetto di benralizumab su remissione, recidiva e uso di corticosteroidi orali
    - sicurezza e tollerabilità di benralizumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Mechanistic Sub-study
    Objective: To evaluate the effect of benralizumab compared to
    mepolizumab on biomarkers related to the mechanism of action (MoA),
    eosinophilic inflammation and EGPA disease pathogenesis, as well as
    baseline predictors of response to benralizumab or mepolizumab.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: I sottostudi sono descritti all'interno del CSP v1 datato 11 Giugno 2019.
    Sottostudio meccanicistico:
    Obiettivo: Valutare l’effetto di benralizumab rispetto a mepolizumab sui biomarcatori correlati al meccanismo d’azione (MoA), sull’infiammazione eosinofila e sulla patogenesi della EGPA, nonché sui fattori predittivi al basale di risposta a benralizumab o a mepolizumab.
    E.3Principal inclusion criteria
    1. Male or female subjects age 18 years or older.
    2. EGPA diagnosis based on history or presence asthma and eosinophilia (>1.0x10^9/L and/or >10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3).
    3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and > 12 weeks prior to screening, or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose <= 7.5 mg/day of prednisolone or equivalent, following standard induction regimen for at least 3 months and within 6 months prior to screening, or recurrence of symptoms upon OCS tapering at any dose of >=7.5 mg/day prednisolone or equivalent. If induction with glucocorticoids alone, patient must have failed to attain remission after 3 months and the glucocorticoid dose must be >=15 mg/day prednisolone or equivalent for the 4 weeks prior to randomization.
    4. Must be on a stable dose of oral prednisolone or prednisone of >=7.5 mg/day (but not >50mg/day) for at least 4 weeks prior to randomization.
    5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted).
    6. QTc(F)<450 msec or QTc(F)<480 msec for patients with bundle branch block.
    7. Females of childbearing potential must use an acceptable method of birth control from signing the informed consent until 4 months after the last study drug administration.
    1. Uomini e donne dai 18 anni in su
    2. Diagnosi di EGPA basata sulla storia clinica o presenza di asma e eosinofilia (>1.0x10^9/L e/o >10% di leucociti) e almeno due tra: biopsia con vasculite eosinofila o infiammazione granulomatosa/perivascolare; mono o poli-neuropatia, infiltrati polmonari non fissi, anormalità sino-nasale; cardiomiopatia; glomerulonefrite; emorragia alveolare; porpora palpabile; positività agli anticorpi anti-citoplasma dei neutrofili (Mieloperossidasi o proteinasi 3)
    3. Storia di recidiva (almeno 1 recidiva confermata di EGPA nei 2 ultimi anni e >12 settimane prima dello screening), oppure refrattaria (mancata remissione entro 6 mesi precedenti lo screening, definita come BVAS=0 e corticosteroidi orali con dose <= 7.5 mg /giorno di prednisolone o equivalenti, seguito da regime induzione standard per almeno 3 mesi, o ricorrenza dei sintomi con riduzione progressiva del dosaggio a qualsiasi dose di >=7.5mg/giorno di prednisolone o equivalente.
    Se l’induzione è con solo glucocorticoidi, i pazienti devono non raggiungere la remissione dopo 3 mesi e con dose di glucocorticoidi di >=15 mg/giorno di prednisolone o equivalente per le 4 settimane precedenti la randomizzazione.
    4. I pazienti devono essere in dosaggio stabile di prednisolone o prednisone orale di =7.5 mg/giorno(ma non >50mg/giorno) per almeno 4 settimane prima della randomizzazione
    5. Se in terapia immunosoppressiva (ad esclusione della ciclofosfamide) la dose deve essere stabile nelle settimane precedenti la randomizzazione e durante lo studio (riduzione di dose permessa per quastioni di sicurezza)
    6. QTc(F)<450 msec o QTc(F)<480 per pazienti con blocco di branca
    7. Donne in età fertile devono usare metodi contraccetivi accettabili per il controllo delle nascite dalla firma del modulo di consenso informato fino a 4 mesi dopo l’ultima dose del farmaco di studio
    E.4Principal exclusion criteria
    1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
    2. Organ or life-threatening EGPA < 3 months prior to screening
    3. Currently pregnant or breastfeeding, or planning to become pregnant during study participation.
    4. Current malignancy or history of malignancy, unless received curative therapy >5 years ago, or >1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix
    5. An untreated or refractory helminth parasitic infection < 24 weeks prior to screening
    6. Unstable liver disease
    7. Severe or clinically significant, uncontrolled cardiovascular disease
    8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients' ability to complete entire duration of the study
    9. Chronic or ongoing infectious disease requiring systemic antiinfective treatment
    10. Known immunodeficiency disorder or positive HIV test
    11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screenin, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-a or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening or an investigational drug within 30 days or 5 terminal phase drug half-lives, whichever is longer, prior to screening.
    1. Diagnosi di granulomatosi con poliangioite (GPA) o poliangioite microscopica (MPA)
    2. Pericolo di vita o di insufficienza d’organo da EGPA <3 mesi precedenti lo screening
    3. Gravidanza o allattamento in corso o pianificata durante la durata dello studio
    4. Carcinoma corrente o storia clinica di carcinoma, eccetto se terapia ricevuta >5 anni fa, o >1 anno fa per carcinoma a cellule basali, carcinoma localizzato a cellule squamose o carcinoma in situ della cervice
    5. Infezione parassitica da elminti non trattata o refrattaria <24 settimane prima dello screening
    6. Malattie epatiche instabili
    7. Malattie cardiovascolari non controllate, gravi o clinicamente significative
    8. Altre malattie che possano mettere in pericolo il paziente o che possano influenzare il risultato dello studio, o la capacità del paziente di completare l’intera durata dello studio
    9. Infezioni in corso o croniche che richiedano trattamenti anti-infettivi sistemici
    10. Nota immunodeficienza o positività al test HIV
    11. Precente terapia di Mepolizumab, Reslizumab, Dupilumab o benralizumab. Terapia con corticosteroidi intravenosa/subcutanea/intramuscolare nelle 4 settimane precedenti la randomizzazione, terapia di omalizumab entro 130 giorni prima dello screening, rituximab entro 6 mesi prima dello screening (o mancato recupero di cellule B), interferone- a o alemtuzumab entro i 6 mesi precdenti lo screening, terapia di anti-tumor necrosis factor entro le 12 settimane precedenti lo screening o un farmaco sperimentale entro un periodo di 5 volte l’emivita plasmatica terminale o comunque almeno 30 giorni precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS=0 and OCS dose = 4mg/day (Main Remission definition) at both weeks 36 and 48.

    Supportive endpoint: Proportion of patients who have achieved remission defined by BVAS =0 and OCS dose = 7.5 mg/day (Supportive remission definition) at both weeks 36 and 48.
    Proporzione di pazienti con EGPA recidivante o refrattaria che raggiungono la remissione, definita come BVAS=0 e dose di OCS =4 mg/giorno (definizione di remissione principale) sia alla Settimana 36 che alla Settimana 48.
    Endpoint di supporto: Percentuale di pazienti che raggiungono la remissione, definita da BVAS =0 e dose di OCS =7,5 mg/giorno (definizione di remissione di supporto) sia alla Settimana 36 che alla Settimana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both weeks 36&48
    Settimane 36 e 48.
    E.5.2Secondary end point(s)
    Study secondary end point(s) – double-blind period:
    - Total accrued duration of remission for the following categories: 0 wk, >0 to <12 wk, 12 to <24 wk, 24 to <36 wk, =36 wk. Analysis will be repeated based on main and supportive remission definitions.
    - Time from randomisation to first EGPA relapse, where relapse is defined as any of the following:
    *Active vasculitis (BVAS >0); OR
    *Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR
    *Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting any of the following:
    an increase of OCS therapy (>4mg prednisolone total daily dose or equivalent);
    an increased dose or addition of an immunosuppressive agent;
    Hospitalisation related to EGPA worsening.
    - Proportion of patients in each category of average daily prednisolone/prednisone dose during weeks 48 to 52 using the following categories: 0; >0 to =4 mg; >4 to =7.5 mg and > 7.5 mg
    - Annualized relapse rate
    - Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period. Analysis will be repeated based on main and supportive remission definitions.
    - BVAS, VDI, pulmonary function testing, asthma symptoms (ACQ-6), sino-nasal symptoms (including SNOT-22 questionnaire), health-related quality of life (SF-36v2), PGIS, WPAI and blood eosinophil counts will be assessed as change from baseline over the 52-week treatment period. PGIC will be assessed as response proportions at each weekly assessment between Visits 2 and 4
    - Safety and tolerability will be evaluated based on AEs, Vital signs, physical exam, Clinical laboratory, and electrocardiogram (ECG).

    Study end point(s) for open label extension (OLE) period:
    - Remission, relapse (as defined in the secondary endpoints), OCS use
    - Safety and tolerability will be evaluated based on AEs, Vital signs, physical exam, Clinical laboratory, and ECG .
    - Serum benralizumab concentrations, Anti-benralizumab antibodies and neutralizing antibodies
    PERIODO DOPPIO CIECO
    - Durata accumulata totale della remissione per le categorie seguenti: sett. 0, sett. da >0 a <12, sett. da 12 a <24, sett. da 24 a <36, sett. >=36. L’analisi sarà ripetuta sulla base delle definizioni di remissione principale e di supporto.
    - Tempo dalla randomizzazione alla prima recidiva di EGPA, dove recidiva è definita come una dei seguenti:
    * vasculite attiva (BVAS>0) OPPURE
    * sintomi e/o segni di asma attiva con corrispondente peggioramento del punteggio ACQ-6;
    * Patologia nasale e/o sinusale attiva, con corrispondente peggioramento in almeno uno dei sintomi sino-nasali che richieda uno degli interventi seguenti:
    --aumento della terapia corticosteroide orale (>4mg totali giornalieri di prednisolone o equivalente);
    --aumento della dose o aggiunta di un agente immunosoppressivo;
    --ricovero correlato al peggioramento di EGPA.
    - Percentuale di pazienti in ciascuna categoria di dose giornaliera media di prednisolone/prednisone durante le settimane da 48 a 52 utilizzando le categorie seguenti: 0; da >0 a =4 mg; da >4 a =7,5 mg e >7,5 mg
    - Tasso di recidiva annualizzato
    - proporzione di pazienti che raggiungono la remissione nelle prime 24 settimane e restano in remissione per il resto del periodo in doppio-cieco. L’analisi sarà ripetuta sulla base delle definizione di remissione principale e di supporto
    - BVAS, VDI, il test di funzionalità respiratoria, i sintomi dell’asma (ACQ-6), i sintomi sino-nasali (incluso il questionario SNOT-22), la qualità della vita correlata alla salute (SF-36v2), PGIS, WPAI e la conta degli eosinofili nel sangue saranno valutati come variazioni rispetto al basale durante il periodo di trattamento di 52 settimane. L’impressione globale di cambiamento del paziente (PGIC) sarà valutata come percentuali di risposta a ogni valutazione settimanale tra le Visite 2 e 4.
    - Sicurezza e tollerabilità saranno valutate sulla base degli eventi avversi, segni vitali, esami fisici, esami di laboratorio clinico ed elettrocardiogramma (ECG)

    Periodo di estensione open label:
    - Remissione, recidiva (come definita negli endpoint secondari), uso di corticosteroidi orali
    - Sicurezza e tollerabilità saranno valutata sulla base degli eventi avversi, segni vitali, esami fisici, esami di laboratorio clinico ed elettrocardiogramma (ECG)
    - Concentrazioni sieriche di Benralizumab, anticorpi anti-benralizumab e anticorpi neutralizzanti
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varies depending on the endpoint/objective
    Vario a seconda dell'endpoint/obbiettivo
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    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 end of study is defined as the last expected visit/contact of the last patient undergoing the study.
    La fine dello studio è definita come l'ultima visita/contatto atteso dell'ultimo paziente dello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 83
    F.4.2.2In the whole clinical trial 140
    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
    NA
    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 Decision2020-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA