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    Summary
    EudraCT Number:2015-001573-40
    Sponsor's Protocol Code Number:EFC13691
    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:2021-05-27
    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 number2015-001573-40
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of dupilumab in patients with severe steroid dependent asthma
    Studio in doppio cieco, randomizzato, controllato con placebo volto a valutare l'efficacia e la sicurezza di dupilumab in pazienti con asma grave dipendente da steroidi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Dupilumab in Patients with Severe Steroid Dependent Asthma
    Valutazione di Dupilumab in pazienti con asma grave dipendente da steroidi
    A.3.2Name or abbreviated title of the trial where available
    VENTURE
    VENTURE
    A.4.1Sponsor's protocol code numberEFC13691
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1170-7152
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO, 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi-aventis.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 namedupilumab
    D.3.2Product code SAR231893
    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 INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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
    Asma
    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 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 evaluate the efficacy of dupilumab, compared with placebo, for
    reducing the use of maintenance oral corticosteroids (OCS) in patients
    with severe steroid-dependent asthma
    Valutazione dell¿efficacia di dupilumab vs placebo nel ridurre l¿utilizzo di corticosteroidi di mantenimento in pazienti con asma dipendente da steroide
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of dupilumab.
    - To evaluate the effect of dupilumab in improving patient-reported outcomes.
    - To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.
    - Valutazione della sicurezza e la tollerabilit¿ di dupilumab
    - Valutazione dell'effetto di dupilumab nel miglioramento degli esiti riferiti dai pazienti
    - Valutazione dell'esposizione sistemica a dupilumab e incidenza dello sviluppo di anticorpi anti-farmaco
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult and adolescent patients with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014
    guidelines and the following criteria:
    1) Patients with severe asthma and a well-documented requirement for regular treatment with maintenance systemic corticosteroids in the 6
    months prior to Visit 1 and using a stable OCS dose for 4 weeks prior to Visit 1. Patients must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at Visit 1 and at the Randomization visit. In addition, the patient must agree to switch to
    study-required prednisone/prednisolone as their OCS and use it per protocol for the duration of the study.
    2) Existing treatment with high-dose inhaled corticosteroid (ICS; >500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist
    [LABA], leukotriene receptor antagonist [LTRA]) for at least 3 months with a stable dose of ICS for =1 month prior to Visit 1. In addition, patients requiring a third controller for their asthma are considered
    eligible for this study.
    3) A forced expiratory volume in 1 second (FEV1) <80% of predicted normal during the Screening period, prior to randomization.
    4) Evidence of asthma as documented by either: reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg (2 to 4 puffs of albuterol/salbutamol) before randomization or documented in the 12 months prior to Visit 1 OR airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 12 months prior to Visit 1.
    - Pazienti adulti e adolescenti con diagnosi clinica di asma da =12 mesi, diagnosi in accordo alle linee guida GINA 2014 (Global Initiative for Asthma) e rispondenti ai seguenti criteri:
    1) Pazienti con asma severa e necessità, ben documentata, di trattamento regolare con dosi di mantenimento di corticosteroidi sistemici da almeno 6 mesi prima della visita 1, con una dose stabile da 4 settimane prima della visita 1. I pazienti devono assumere da 5 a 35 mg/die di prednisone/prednisolone, o equivalente, alla visita 1 e alla visita di randomizzazione. Inoltre i pazienti devono acconsentire a modificare il trattamento in accordo a quello consentito dallo studio (prednisone/prednisolone) come corticosteroide orale e continuare ad usarlo per l’intera durata dello studio.
    2) Trattamento con dose medio-alta di corticosterioidi inalatori (ICS; >500 mcg di fluticasone propionato al giorno o dose di ICS equipotente) in combinazione con un secondo farmaco di controllo dell'asma (ad es. beta agonista a lunga azione (LABA), antagonisti dei recettori dei leucotrieni LTRA) da almeno 3 mesi con una dose stabile da =1 mese prima della visita 1. I pazienti che richiedano un terzo farmaco di controllo dell'asma saranno considerati eleggibili per questo studio.
    3) Volume espiratorio forzato (FEV1) <80% del valore normale atteso durante lo screening, prima della randomizzazione.
    4) Evidenza di asma documentata da uno dei due criteri sotto elencati:
    - Reversibilità del FEV1 di almeno 12% e 200 ml dopo la somministrazione di 200-400 mcg di albuterolo/salbutamolo (2-4 inalazioni di albuterolo/salbutamolo) prima della randomizzazione o documentata nei 12 mesi precedenti la visita 1
    oppure
    Iperresponsività delle vie aeree (mediante Test della metacolina: concentrazioni che provochino una reazione positiva [PC20] di <8mg/ml) documentata nei 12 mesi precedenti la Visita 1
    E.4Principal exclusion criteria
    - Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those
    countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are =18 years of age).
    - Patients who weigh <30 kg.
    - Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome) which may impair lung function.
    - Clinical evidence or imaging (eg, chest X-ray, computed tomography, magnetic resonance imaging) within 12 months of Visit 1 with clinically
    significant findings of lung disease(s) other than asthma, as per local standard of care.
    - A patient who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment,
    hospitalization due to asthma, or treatment with systemic steroids at least twice their current dose for at least 3 days) within 4 weeks before Visit 1.
    - A subject who requires 12 puffs or more of rescue medication on any 1 day in the week prior to Visit 1.
    - A subject who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to screening.
    - Current smoker or cessation of smoking within 6 months prior to Visit 1.
    - Previous smoker with a smoking history >10 pack-years.
    - Comorbid disease that might interfere with the evaluation of the investigational medicinal product.
    - Pazienti di età <12 anni o con età inferiore all’età legalmente valida per pazienti adolescenti nel paese del centro sperimentale (per i paesi che permettano l’inclusione dei soli adulti l’arruolamento sarà ristretto a pazienti con età =18 anni)
    - Peso inferiore a 30 kg
    - Broncopneumopatia cronica ostruttiva o altra patologia polmonare (ad es. fibrosi polmonare idiopatica, sindrome di Churg-Strauss), che possano compromettere la funzionalità polmonare
    - Evidenza clinica o radiologica (ad es. RX del torace, tomografia computerizzata,
    risonanza magnetica, quale che sia l’esame secondo normale pratica clinica) con risultati clinicamente significativi, di patologie polmonari differenti dall'asma nei 12 mesi antecedenti la visita 1
    - Pazienti con riacutizzazione severa dell'asma (definita come peggioramento dell'asma che renda necessario un trattamento di emergenza, ricovero a causa dell'asma o trattamento steroideo sistemico a dosaggi di due volte superiori rispetto alla dose prescritta per almeno tre giorni consecutivi) nelle 4 settimane prima della visita di screening V1
    - Pazienti che richiedano 12 o più inalazioni (puff) di farmaco al bisogno anche solo per un giorno nella settimana precedente alla visita 1
    - Pazienti che abbiano avuto un infezione delle vie aeree superiori od inferiori nelle 4 settimane precedenti lo screening
    - Paziente attualmente fumatore o che abbia interrotto il fumo nei 6 mesi precedenti la visita 1
    - Ex fumatore con storia di tabagismo > 10 pack-years
    - Comorbidità che possano interferire con la valutazione dell'IMP
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change in OCS dose while maintaining asthma control
    Riduzione percentuale della dose di OCS pur mantenendo il controllo dell'asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 24
    Basale, settimana 24
    E.5.2Secondary end point(s)
    1 - Proportion of patients achieving a reduction of 50% or greater in their OCS dose while maintaining asthma control.
    2 - Absolute reduction of OCS dose while maintaining asthma control
    3 - Proportion of patients achieving a reduction of OCS dose to <5 mg while maintaining asthma control
    4 - Proportion of patients achieving a reduction of OCS dose to 0 while maintaining asthma control
    5 - Proportion of patients achieving their maximum possible reduction of OCS dose per protocol while maintaining asthma control
    1 - Proporzione di pazienti che raggiunge una riduzione del 50% o superiore, della propria dose di OCS, pur mantenendo il controllo dell'asma
    2 - Riduzione assoluta della dose di OCS pur mantenendo il controllo dell'asma
    3 - Proporzione di pazienti che raggiunge una riduzione della dose di OCS a <5 mg pur mantenendo il controllo dell'asma
    4 - Proporzione di pazienti che raggiunge una riduzione della dose di OCS a 0 mg pur mantenendo il controllo dell'asma
    5 - Proporzione di pazienti che raggiunge la riduzione massima possibile della propria dose di OCS come da protocollo pur mantenendo il controllo dell'asma
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 24
    Basale, settimana 24
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Brazil
    Canada
    Colombia
    Israel
    Mexico
    Russian Federation
    Ukraine
    United States
    Belgium
    Italy
    Netherlands
    Poland
    Romania
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    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 years2
    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 Yes
    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: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 367
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescent patients, aged 12 years to less than 18 years, will provide assent to enter the study and their parents/legal guardians will provide consent.
    Pazienti adolescenti, con et¿ tra 12 anni e meno di 18 anni, forniranno l'assenso per entrare nello studio e i loro genitori / tutori legali forniranno il
    consenso.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 380
    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
    Nessuno
    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 Decision2015-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
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