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    Summary
    EudraCT Number:2017-003317-25
    Sponsor's Protocol Code Number:LTS14424
    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:2018-09-21
    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 number2017-003317-25
    A.3Full title of the trial
    One year study to evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study
    Studio di un anno volto a valutare la sicurezza e la tollerabilità a lungo termine di dupilumab in pazienti pediatrici che abbiano partecipato a un precedente studio clinico con dupilumab nell’asma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the Safety and Efficacy of Dupilumab in Children with Asthma (Liberty Asthma Excursion)
    Valutazione della Sicurezza e dell’Efficacia di Dupilumab in Bambini con Asma (Liberty Asthma Excursion)
    A.4.1Sponsor's protocol code numberLTS14424
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1200-1757
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/304/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-aventis recherche & développement
    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 & développement
    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 number0039800226343
    B.5.5Fax number00390239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 in pre-filled syringe
    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.3.9.3Other descriptive nameREGN668
    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 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 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 namedupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.3Other descriptive nameREGN668
    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 number175
    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 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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
    Valutare la sicurezza e la tollerabilità a lungo termine di dupilumab in pazienti pediatrici con asma che abbiano partecipato a un precedente studio clinico di dupilumab nell’asma
    E.2.2Secondary objectives of the trial
    -To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
    -To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab
    asthma clinical study with regard to:
    -Systemic exposure.
    -Anti-drug antibodies (ADAs).
    -Biomarkers.
    Valutare l’efficacia a lungo termine di dupilumab in pazienti pediatrici con asma che abbiano partecipato a un precedente studio clinico di dupilumab nell’asma
    -Valutare dupilumab in pazienti pediatrici con asma che abbiano partecipato a un precedente studio clinico di dupilumab nell’asma in merito a:
    • Esposizione sistemica
    • Anticorpi anti-farmaco (anti-drug antibodies [ADA])
    • Biomarcatori
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).
    -Signed written informed consent/assent.
     Pazienti pediatrici con asma che abbiano completato il trattamento durante una sperimentazione con dupilumab nell’asma (EFC14153).
     Consenso/assenso informato firmato per iscritto.
    E.4Principal exclusion criteria
    -Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.
    -Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).
    -Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study.
    -Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study.
    -Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
    -Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient’s participation in this study or would require permanent IMP discontinuation.
    -For female patients who have commenced menstruating at any time during the study and are either:
    -Found to have a positive urine pregnancy test, or
    -Sexually active, not using an established acceptable contraceptive method.
    -Planned live, attenuated vaccinations during the study.
    -Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment.
     Qualsiasi malattia polmonare cronica diversa dall’asma (per esempio: fibrosi cistica, displasia broncopolmonare) che possa compromettere la funzionalità polmonare
     Incapacità di seguire le procedure dello studio/non conformità (per esempio a causa di problemi linguistici o disturbi psicologici).
     Pazienti che ricevano un trattamento concomitante o abbiano richiesto un nuovo trattamento concomitante proibito dallo studio.
     Pazienti o loro genitori / caregiver(s) / tutori legali che siano correlati con lo Sperimentatore o qualsiasi co-sperimentatore, assistente di ricerca, farmacista, study coordinator, o altro personale direttamente coinvolto nella conduzione dello studio.
     Pazienti che abbiano manifestato eventuali reazioni di ipersensibilità a dupilumab in un precedente studio con dupilumab, in base alle quali il proseguimento del trattamento con dupilumab può rappresentare, a giudizio dello sperimentatore, un rischio irragionevole per gli stessi.
     Tutte le anomalie o gli eventi avversi al momento dell’arruolamento (l’ultima visita di trattamento dello studio EFC14153 corrisponderà alla visita di arruolamento) che, a giudizio dello sperimentatore, possano influire negativamente sulla partecipazione del paziente a questo studio o possano richiedere l’interruzione permanente dell’IMP.
     Per pazienti di sesso femminile che abbiano il menarca in qualsiasi momento durante lo studio e sono:
    • Risultate positive al test di gravidanza sulle urine, o
    • Sessualmente attive, che non utilizzano un consolidato ed accettabile metodo contraccettivo.
    - Vaccinazioni con virus vivi o attenuati pianificate durante lo studio
    - Pazienti con patologie autoimmuni attive o pazienti che utilizzano terapie immunosuppressive per patologie autoimmuni (ad esempio, artrite idiopatica giovanile, malattia infiammatoria intestinale, lupus eritematoso sistemico) all’arruolamento

    E.5 End points
    E.5.1Primary end point(s)
    Treatment-emergent-adverse-event (TEAEs): The number (n) and percentage (%) of patients experiencing any TEAEs.
    Eventi avversi emergenti dal trattamento (treatment-emergent adverse events - TEAEs): il numero (n) e la percentuale (%) di pazienti che hanno manifestato eventuali TEAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 1 up to Week 64
    dal giorno 1 alla settimana 64
    E.5.2Secondary end point(s)
    1) Severe asthma exacerbation events: Annualized rate of severe asthma exacerbation events, during the treatment period
    2) Change in % predicted FEV1: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
    3) Change in absolute FEV1: Change in absolute FEV1 - Clinically significant changes from baseline
    4) Change in FVC: Change in forced vital capacity (FVC)
    5) Change in FEF: Change in forced expiratory flow [FEF] 25-75%)
    6) Assessment of dupilumab concentration: Serum dupilumab concentrations - Changes from first dupilumab injection
    7) Assessment of immunogenicity: Titers of Anti-dupilumab antibodies
    8) Assessment of blood Eosinophil count: Blood: Eosinophil count
    9) Assessment of immunoglobulins: Serum: Immunoglobulins (Ig)
    10) Assessment of total anti-immunoglobulin E (IgE): Serum: total IgE

    1) eventi di grave esacerbazione dell’asma: tasso annualizzato di eventi di grave esacerbazione dell’asma durante il periodo di trattamento.
    2) Variazione in % del FEV1 previsto : Variazione in percentuale (%) del volume espiratorio forzato in 1 secondo (forced expiratory volume in 1 second [FEV1]) – Variazioni clinicamente significative rispetto al basale
    3) Variazione della FEV1 assoluta: variazione della FEV1 assoluta - Variazioni clinicamente significative rispetto al basale
    4) Variazioni della CVF: variazioni della capacità vitale forzata (CVF)
    5) Variazioni del FEF: variazioni del flusso espiratorio forzato (FEF 25-75%)
    6) Valutazione della concentrazione di dupilumab: concentrazioni di dupilumab nel siero – variazioni dalla prima iniezione di dupilumab
    7) Valutazione dell’immunogenicità: titoli anticorpali Anti-dupilumab
    8) Valutazione della conta degli eosinofili nel sangue: Sangue: conta degli eosinofili
    9) Valutazione delle immunoglobuline: Siero: immunoglobuline (Ig)
    10) Valutazione delle immunoglobuline E (IgE) totali: Siero: IgE totali
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) From Day 1 up to Week 52
    2) to 10) From Day 1 up to Week 64
    1) Dal giorno 1 fino alla settimana 52
    Da 2) a 10) Dal giorno 1 fino alla settimana 64
    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 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 No
    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.8.2.4Number of treatment arms in the trial1
    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 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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Hungary
    Italy
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Turkey
    Ukraine
    United States
    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 years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months90
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 377
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 327
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    pediatric population
    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 83
    F.4.2.2In the whole clinical trial 377
    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 Decision2018-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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