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    Summary
    EudraCT Number:2015-001573-40
    Sponsor's Protocol Code Number:EFC13691
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-05
    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 ConcernedSpain - AEMPS
    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
    Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de dupilumab en pacientes con asma grave dependiente de corticoesteroides
    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
    Evaluación de dupilumab en pacientes con asma grave dependiente de corticosteroides
    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 ET 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-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@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.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 in pre-filled syringe
    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 18.0
    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.
    Evaluar la eficacia de dupilumab en comparación con placebo para reducir el uso de corticosteroides orales (CEO) de mantenimiento en pacientes con asma grave dependiente decorticoesteroides.
    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.
    Evaluar la seguridad y la tolerabilidad de dupilumab.
    Evaluar el efecto de dupilumab a la hora de mejorar los resultados percibidos por el paciente (RPP).
    Evaluar la exposición sistémica a dupilumab y la incidencia de anticuerpos antifármaco (AAF) aparecidos durante el tratamiento.
    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:
    - 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.
    - 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.
    - A forced expiratory volume in 1 second (FEV1) <80% of predicted normal during the Screening period, prior to randomization.
    - 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.
    I 01. Pacientes adultos y adolescentes con un diagnóstico médico de asma durante ? 12 meses, según las Directrices de la Iniciativa Global para el Asma (Global Initiative for Asthma, GINA) de 2014 y los siguientes criterios:
    A) Pacientes con asma grave y un requisito bien documentado de tratamiento regular con corticosteroides sistémicos de mantenimiento en los 6 meses previos a la Visita 1 y con uso de una dosis estable de CEO durante las 4 semanas previas a la Visita 1. Los pacientes deben estar tomando 5-35 mg/día de prednisona/prednisolona, o el equivalente, en la Visita 1 y en la visita de Aleatorización. Además, el paciente debe comprometerse a cambiar a la prednisona/prednisolona requerida por el estudio como su CEO y usarla conforme al protocolo durante todo el estudio.
    B) Tratamiento existente con una dosis alta de corticosteroides inhalados (ICS; dosis diaria total de > 500 mcg de propionato de fluticasona o equivalente) en combinación con un segundo medicamento de control (p. ej., agonistas ?2 de larga duración [long-acting beta agonist, LABA], antagonista del receptor de leucotrienos [leukotriene receptor antagonist, LTRA]) durante al menos 3 meses con una dosis estable de ICS durante ? 1 mes antes de la Visita 1. Además, los pacientes que requieran un tercer medicamento de control para su asma se considerarán aptos para este estudio.
    C) Un volumen espiratorio forzado en 1 segundo (VEF1) < 80 % del valor normal previsto durante el período de Selección, antes de la aleatorización.
    D) Evidencias de asma documentadas por:
    - Reversibilidad de al menos el 12 % y 200 ml en VEF1 tras la administración de 200 a 400 mcg (de 2 a 4 inhalaciones de albuterol/salbutamol) antes de la aleatorización o documentada en los 12 meses previos a la Visita 1 O
    - Hiperreactividad de las vías respiratorias (metacolina: concentración provocativa quecausa una reacción positiva [PC20] de < 8 mg/ml) documentada en los 12 meses previos a 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.
    E 01. Pacientes < 12 años de edad o la edad legal mínima para adolescentes en el país del centro de investigación, la que sea mayor (en aquellos países en los que las regulaciones locales permitan únicamente la inclusión de adultos, el reclutamiento de pacientes se limitará a aquellos que tengan ? 18 años).
    E 02. Pacientes que pesen < 30 kg.
    E 03. Enfermedad pulmonar obstructiva crónica (EPOC) u otras enfermedades pulmonares (p. ej., fibrosis pulmonar idiopática, síndrome de Churg-Strauss, etc.) que puedan afectar a la función pulmonar.
    E 04. Evidencias clínicas o diagnóstico por imagen (p. ej., radiografía de tórax, tomografía computarizada, resonancia magnética [RM]) en los 12 meses previos a la Visita 1 con hallazgos clínicamente significativos de enfermedad(es) pulmonar(es) que no sea(n) asma, según la práctica médica estándar local.
    E 05. Un paciente que experimente una exacerbación de asma grave (definida como un empeoramiento del asma que dé lugar a un tratamiento de urgencia, hospitalización por asma o tratamiento con esteroides sistémicos al menos el doble de su dosis actual durante al menos 3 días) en las 4 semanas previas a la Visita 1.
    E 06. Un paciente que requiera 12 inhalaciones o más de medicación de rescate en 1 día cualquiera de la semana previa a la Visita 1.
    E 07. Un paciente que haya experimentado una infección de las vías respiratorias superiores o inferiores en las 4 semanas previas a la Selección.
    E 08. Fumador actual o cese del hábito tabáquicor en los 6 meses previos a la Visita 1.
    E 09. Fumador previo con un antecedente de tabaquismo > 10 paquetes-año.
    E 10. Comorbilidad que pudiera interferir con la evaluación del PI.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change in OCS dose while maintaining asthma control
    Porcentaje de reducción de la dosis de CEO mientras se mantiene el control del asma
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 24
    En la Semana 24 en comparación con la dosis basal
    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/ Proporción de pacientes que logra una reducción del 50 % o superioren su dosis de CEO en comparación con la dosis basal en la Semana 24, mientras mantienen el control del asma.
    2/ Reducción absoluta de la dosis de CEO en la Semana 24 en comparación con la dosis basal mientras se mantiene el control del asma.
    3/ Proporción de pacientes que logran una reducción de la dosis de CEO hasta < 5 mg en la Semana 24 mientras mantienen el control del asma.
    4/ Proporción de pacientes que logra una reducción de la dosis de CEO hasta 0 en la Semana 24 mientras mantienen el control del asma.
    5/ Proporción de pacientes que logran la máxima reducción posible de la dosis de CEO conforme al protocolo en la Semana 24 mientras mantienen el control del asma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 24
    En la Semana 24 en comparación con la dosis basal
    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 concerned8
    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 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
    Belgium
    Brazil
    Canada
    Colombia
    Israel
    Italy
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    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
    Última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 8
    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.
    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 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
    Ninguno
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-13
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