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    Summary
    EudraCT Number:2018-002738-19
    Sponsor's Protocol Code Number:ESR-17-13092
    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:2020-10-07
    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 number2018-002738-19
    A.3Full title of the trial
    NAsal Polyps: inflammatory & molecular Phenotyping of REsponders to Benralizumab
    Poliposi NAsale: fenotipizzazione infiammatoria e molecolare di REsponders a Benralizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Molecular inflammatory characterization of patients with nasal polyposis that respond to treatment with Benralizumab
    Caratterizzazione infiammatoria molecolare di pazienti con poliposi nasale che rispondono al trattamento con Benralizumab
    A.3.2Name or abbreviated title of the trial where available
    NAPPREB
    NAPPREB
    A.4.1Sponsor's protocol code numberESR-17-13092
    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 SponsorIRCCS ISTITUTO CLINICO HUMANITAS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto Clinico Humanitas
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressVia Alessandro Manzoni 56
    B.5.3.2Town/ cityRozzano MI
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.4Telephone number0282241
    B.5.5Fax number0282241
    B.5.6E-mailpaola.maisola@humanitas.it
    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 [NA]
    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.3.9.2Current sponsor codeND
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with chronic rhinosinusinusitis with nasal polyps
    Pazienti con rinosinusite cronica con poliposi nasale
    E.1.1.1Medical condition in easily understood language
    Patients with chronic rhinosinusinusitis with nasal polyps
    Pazienti con rinosinusite cronica con poliposi nasale
    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 LLT
    E.1.2Classification code 10052106
    E.1.2Term Rhinosinusitis
    E.1.2System Organ Class 100000004862
    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 clinical efficacy of Benralizumab on CRSwNP at week 24 (vs baseline) after the beginning of treatment, and to correlate the presence of baseline biomarkers with nasal polyp (NP) score improvement, in order to identify any possible predictive biomarker of response to Benralizumab.
    Valutare l’efficacia clinica di Benralizumab sulla CRSwNP alla 24esima settimana di trattamento (rispetto al basale), e correlare la presenza di biomarcatori misurati al basale con il miglioramento del punteggio “Nasal Polyp score”, per identificare possibili biomarcatori associati alla terapia con Benralizumab.
    E.2.2Secondary objectives of the trial
    In the follow up phase we will monitor all the biomarkers at 32 and 52 weeks , this monitoring will ascertain if any of those will predict relapse of NP and consequently when Benralizumab treatment has to be reinstalled.
    Nella fase di monitoraggio post-terapia, verranno valutati biomarcatori (a 32 e 52 settimane) predittivi di recidiva della poliposi nasale e conseguentemente della necessità di reintraprendere trattamento con Benralizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with:
    - Nasal polyps score (Meltzer et al.) > 5
    - Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrea; 0-10 for each symptom) > 24
    - Provision of informed consent prior to any study specific procedure
    Pazienti adulti con rinosinusite cronica con polipi nasali (allergici e non allergici) che richiedono minimo 1000 mg di prednisone orale nei precedenti dodici mesi per controllare i sintomi della rinosinusite, e con:
    - Punteggio polipi nasali (Meltzer et al.) > 5
    - Segni dei punteggi VAS (per ostruzione nasale, iposmia, gocciolamento post-nasale, starnuti, rinorrea; ogni sintomo) > 24
    - Fornitura di consenso informato prima di qualsiasi procedura specifica di studio
    E.4Principal exclusion criteria
    - Patients < 18 years age
    - Pregnant women. If not pregnant, the patient must agree to voluntarily adopts highly effective contraceptive measures (intrauterine device [IUD] in copper; diaphragm; condom [from the partner], spermicide, hormonal contraceptive [i.e. birth control pill] and abstinence [no heterosexual activity]) to prevent pregnancy during the entire study period.
    - Biologic therapy in the past 6 months (or at least a period corresponding to 5 half-life of used drugs) (eg: omalizumab, mepolizumab, reslizumab, dupilumab)
    - Previous treatment with Benralizumab
    - Known hypersensitivity to benralizumab or any of its excipients
    - Immunosuppression other than oral steroids in the past 3 months
    - Allergen immunotherapy in the past 6 months
    - Serious life threatening cardiopulmonary disorders
    - Systemic immunologic disorder in the last 12 months
    - Positive history for malignant tumors ever in patient’s life
    - Patients with conditions or concomitant diseases making them non evaluable at visit 1 or for the primary efficacy endpoint:
    a) Ongoing rhinitis medicamentosa
    b) Nasal septal deviation occluding at least one nostril
    c) Acute sinusitis, nasal infection, upper respiratory infections
    d) Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis
    e) Eosinophilic Granulomatosis with Polyangiitis (previously named Churg-Strauss Syndrome)
    f) Granulomatosis with Polyangiitis (previously named Wegener’s granulomatosis)
    g) Young’s Syndrome
    h) Kartagener’s Syndrome
    i) all ciliary dyskinesia
    j) Cystic Fibrosis
    - Patients with severe asthma, defined according to ERS/ATS definition
    - Pazienti di età <18 anni
    - Donne incinte. Se non è incinta, il paziente deve accettare di adottare volontariamente misure contraccettive altamente efficaci (dispositivo intrauterino [IUD] in rame, diaframma, preservativo [dal partner], spermicida, contraccettivo ormonale [pillola anticoncezionale] e astinenza [nessuna attività eterosessuale]) per prevenire la gravidanza durante l'intero periodo di studio.
    - Terapia biologica negli ultimi 6 mesi (o almeno un periodo corrispondente a 5 emivita di farmaci usati) (es .: omalizumab, mepolizumab, reslizumab, dupilumab)
    - Trattamento precedente con Benralizumab
    - Ipersensibilità nota a benralizumab o ad uno qualsiasi dei suoi eccipienti
    - Immunosoppressione diversa dagli steroidi orali negli ultimi 3 mesi
    - Immunoterapia con allergeni negli ultimi 6 mesi
    - Disturbi cardiopolmonari gravi e potenzialmente letali
    - Disturbo immunologico sistemico negli ultimi 12 mesi
    - Anamnesi positiva per tumori maligni nella vita del paziente
    - Pazienti con condizioni o malattie concomitanti che li rendono non valutabili in visita 1 o per l'endpoint primario di efficacia:
    a) rinite medicamentosa in corso
    b) Deviazione del setto nasale che occlude almeno una narice
    c) sinusite acuta, infezione nasale, infezioni delle vie respiratorie superiori
    d) sospetto radiologico o rinosinusite fungina invasiva o espansiva confermata
    e) Granulomatosi eosinofila con poliangioite (precedentemente chiamata sindrome di Churg-Strauss)
    f) Granulomatosi con poliangioite (precedentemente denominata granulomatosi di Wegener)
    g) Sindrome di Young
    h) Sindrome di Kartagener
    i) tutta la discinesia ciliare
    j) Fibrosi cistica
    - Pazienti con asma grave, definiti secondo la definizione ERS / ATS
    E.5 End points
    E.5.1Primary end point(s)
    To assess the clinical efficacy of Benralizumab on CRSwNP at week 24 (vs baseline) after the beginning of treatment. Outcome measures will be also put in correlation with baseline biomarkers assessed on biological samples (blood, serum, nasal polyp tissue, exhaled breath) in order to identify any possible predictive biomarker of response to Benralizumab. (see "Clinical evaluation, laboratory tests and follow-up" for more details).
    Valutare l'efficacia clinica di Benralizumab su CRSwNP alla settimana 24 (vs baseline) dopo l'inizio del trattamento. Le misure di outcome saranno anche messe in correlazione con i biomarker di riferimento valutati su campioni biologici (sangue, siero, tessuto polipo nasale, respiro espirato) al fine di identificare qualsiasi possibile biomarcatore predittivo di risposta a Benralizumab. (vedi "Valutazione clinica, test di laboratorio e follow-up" per ulteriori dettagli).
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the follow up phase we will monitor all the biomarkers at 32 and 52 weeks , this monitoring will ascertain if any of those will predict relapse of nasal polyps and consequently when Benralizumab treatment has to be reinstalled.
    Nella fase di follow up controlleremo tutti i biomarcatori a 32 e 52 settimane, questo monitoraggio accerterà se qualcuno di questi prevede la ricaduta di polipi nasali e di conseguenza quando Il trattamento con Benralizumab deve essere reinstallato.
    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 No
    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 trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 20
    F.4.2.2In the whole clinical trial 20
    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)
    Treatment with nasal topical corticosteroids
    Trattamento con corticosteroidi topici nasali
    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 Decision2019-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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