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    Summary
    EudraCT Number:2018-002292-18
    Sponsor's Protocol Code Number:7569
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002292-18
    A.3Full title of the trial
    CT air-trapping characterization for the early identification of Benralizumab responders among eosinophilic asthma patients
    Identification précoce d’une réponse au Benralizumab par caractérisation du trappage aérique chez des patients atteints d’asthme avec éosinophilie

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benralizumab responders and eosinophilic asthma patients
    A.3.2Name or abbreviated title of the trial where available
    BenraliScan
    BenraliScan
    A.4.1Sponsor's protocol code number7569
    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 SponsorUniversity Hospital of Montpellier
    B.1.3.4CountryFrance
    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.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointGuillemette TACONNET DECKER
    B.5.3 Address:
    B.5.3.1Street AddressDRI, Pav 32 - 39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number+334673305573
    B.5.5Fax number+33467339172
    B.5.6E-mailg-taconnet_decker@chu-montpellier.fr
    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 Yes
    D.2.1.1.1Trade name Fasenra (benralizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study population corresponds to severe eosinophilic asthma patients
    La maladie sur laquelle porte l'étude est l'asthme sévère avec éosinophilie
    E.1.1.1Medical condition in easily understood language
    The study population corresponds to severe eosinophilic asthma patients
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the prognostic value (sensitivity and specificity) of air-trapping measures (Expiratory/Inspiratory Mean Lung Density) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (0 to 1 non-severe exacerbation during follow-up versus all others) at 52 weeks among eosinophilic patients with chronic airway disorders treated with Benralizumab.
    E.2.2Secondary objectives of the trial
    • To describe clinical improvement category sub-groups (non-responders versus strong responders)
    • To perform exploratory, prognostic-value studies (including prognostic variables derived changes occurring over 24 weeks and from clustering or factor mining at baseline and 24 weeks). These exploratory studies will include estimating the sensitivity/specificity of baseline/early imaging variables for predicting clinical response variables.
    • To describe the prognostic categories (predicted non-responder versus predicted responder)
    • To create a centralized image library associated with the study.
    • To explore the association between bronchial homothety curves and disease severity/progression.
    • To verify the reproducibility of the relationships found between mean lung density, the fractal dimension of -850 HU segmentations, and clinical variables found during the SCANN’AIR study (NCT03102749).
    • To monitor patient safety throughout the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Understanding and acceptance of the protocol
    •The patient has given his/her informed consent and signed the consent form
    •Affiliation with or beneficiary of the French national health insurance system
    •Female and male patients aged 18 to 75 years (inclusively) with a history of physician-diagnosed severe asthma (according to GINA criteria) requiring treatment with inhaled corticosteroid (ICS) plus asthma controller for at least 12 months prior to inclusion
    Other acceptable asthma controllers include a long acting bronchodilator (LABA or long-acting muscarinic antagonists [LAMA]), a leukotriene inhibitor, theophylline preparations or maintenance oral corticosteroid (OCS) (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent).
    •Documented current treatment with high daily doses of ICS (>1000 µg equivalent beclomethasone) plus at least one other asthma controller for at least 6 months prior to inclusion
    •History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (any administration route) in the 12 months prior to inclusion. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase in their maintenance dose.
    •Uncontrolled disease (Asthma Control Questionnaire >1.5)
    •Pre bronchodilator forced expiratory volume at 1 second (% predicted) between 40% and 85%, established according to the NHANESIII criteria
    •Blood eosinophilia ≥ 300 cells / µl at least twice during the previous 12 months –OR– blood eosinophilia ≥ 300 cells / µl upon inclusion
    •Women of childbearing potential must use at least one acceptable and effective form of birth control
    •Weight ≥ 40 kg
    E.4Principal exclusion criteria
    •Other respiratory diseases or associated lung infections
    •Patient treated with a monoclonal antibody in the 5 months preceding inclusion
    •Patient who participated in a therapeutic study in the month prior to inclusion
    •Patient deprived of liberty by judicial or administrative decision
    •Major (adult) protected by the law (under any kind of guardianship)
    •Patient in an exclusion period determined by another protocol
    •Patient who participated in another research protocol with X-ray exposure in the past 12 months
    •Patient who has already participated in the present protocol
    •Hypersensitivity to benralizumab* or to any of the excipients*: histidine, histidine hydrochloride monohydrate, trehalose dehydrate, polysorbate 20 and water for injections
    •Exacerbation*, antibiotics, or non-maintenance systemic steroids during the 6 weeks prior to inclusion
    •Subjects with untreated helminthic parasitic infection*
    •Lactating or pregnant* females or females who intend to become pregnant
    •Subjects with a history of anaphylaxis to any biologic therapy
    •Subjects taking immunosuppressive medications (except oral prednisone and inhaled and topical corticosteroids)
    •Subjects with intercurrent illnesses (eg, viral illnesses) that may compromise the safety of the subject
    •Subjects who are febrile (≥38°C)
    •Currently smoking or smoking history ≥ 20 pack years
    •Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained
    •Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent when applicable, was obtained
    *Elements mentioned in the Summary of Product Characteristics for benralizumab
    E.5 End points
    E.5.1Primary end point(s)
    The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (E/I MLD) for predicting improvement in exacerbation rate (0 to 1 non-severe exacerbation during follow-up versus all others) at week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    • Number of exacerbations occurring during follow-up
    • FEV1 pre BD
    • ACQ score
    • Concomitant medication
    • Self-questionnaires : ACQ, SNOT22, St-George
    • Plethysmography variables
    • Spirometry variables
    • Blood counts
    • Thoracic CT scans
    • Sinus CT scan
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    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 Yes
    E.6.13.1Other scope of the trial description
    Prognosis
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    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 No
    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
    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 months
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    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 benralizumab may continue as part of the patient’s management according to the advice of the physician.
    Le traitement par benralizumab pourra continuer dans le cadre de la prise en charge du patient selon l’avis du médecin
    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 Decision2019-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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