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    Summary
    EudraCT Number:2013-003254-24
    Sponsor's Protocol Code Number:R668-AD-1224
    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:2014-05-22
    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 number2013-003254-24
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    ESTUDIO ALEATORIZADO, EN DOBLE CIEGO Y CONTROLADO CON PLACEBO, PARA DEMOSTRAR LA EFICACIA Y LA SEGURIDAD A LARGO PLAZO DE DUPILUMAB EN PACIENTES ADULTOS CON DERMATITIS ATÓPICA DE GRADO MODERADO A SEVERO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND LONG TERM SAFETY STUDY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS.
    ESTUDIO DE SEGURIDAD A LARGO PLAZO Y EFICACIA DE DUPILUMAB EN PACIENTES ADULTOS CON DERMATITIS ATÓPICA DE GRADO MODERADO A SEVERO.
    A.4.1Sponsor's protocol code numberR668-AD-1224
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34916006186
    B.5.6E-mailclinicaltrial@regeneron.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/REGN668
    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.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeDupilumab
    D.3.9.3Other descriptive nameREGN668/SAR231893
    D.3.9.4EV Substance CodeSUB128559
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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/REGN668
    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.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeDupilumab
    D.3.9.3Other descriptive nameREGN668/SAR231893
    D.3.9.4EV Substance CodeSUB128559
    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) Yes
    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
    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
    Moderate to severe atopic dermatitis (AD).
    Dermatitis atópica de grado moderado a severo.
    E.1.1.1Medical condition in easily understood language
    Moderate to severe atopic dermatitis (AD).
    Dermatitis atópica de grado moderado a severo.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy of dupilumab over 12 weeks of treatment in adult
    patients with moderate-to-severe atopic dermatitis (AD) who have failed or are intolerant to topical steroids with or without topical calcineurin inhibitors.
    Evaluar la eficacia de dupilumab durante 12 semanas de tratamiento en pacientes adultos con dermatitis atópica (DA) de grado moderado a severo en los que han fracasado los corticoides tópicos, con o sin inhibidores de la calcineurina tópicos.
    E.2.2Secondary objectives of the trial
    -Evaluate efficacy over time of dupilumab when administered for up to 52 weeks.
    -Evaluate the long-term safety of dupilumab administered for up to 52 weeks.
    - Evaluar la eficacia de dupilumab a lo largo del tiempo en su administración durante un máximo de 52 semanas.
    - Evaluar la seguridad a largo plazo de dupilumab en su administración durante un máximo de 52 semanas.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Genomics Sub-study.
    - Blood for DNA extraction should be collected on day 1/baseline (predose), but may be collected at any study visit.
    - The purpose of the genomic analyses is to identify genomic associations with clinical or biomarker response to IL-4R/13R modulation, atopic disease risk, prognosis and progression, or other clinical outcome measures.
    Subestudio genómico opcional:
    - Muestra de ADN debería obtenerse el Día 1/basal; no obstante, podrá extraerse en cualquier momento a lo largo del estudio.
    -El objetivo de los análisis genómicos es identificar asociaciones genómicas con las respuestas clínicas o de biomarcadores a la modulación de IL-4R/13R, con el riesgo de desarrollar enfermedades atópicas, con el pronóstico y la progresión de la enfermedad, o con otras medidas de resultados clínicos.
    E.3Principal inclusion criteria
    1. Male or female, 18 years or older
    2. Chronic AD, (according to the American Academy of Dermatology Consensus Criteria),that has been present for at least 3 years before the screening visit.
    3. Patients with documented recent history (within 6 months before the
    screening visit) of inadequate response to a sufficient course of
    outpatient treatment with topical AD medication(s), or for whom topical AD therapies are medically inadvisable.
    1. Varón o mujer de 18 o más años de edad.
    2. DA crónica (de acuerdo con los Criterios de consenso de la Sociedad Estadounidense de Dermatología (American Academy of Dermatology Consensus Criteria) que haya estado presente durante como mínimo los 3 años anteriores a la visita de selección.
    3. Pacientes con antecedentes recientes (dentro de los 6 meses previos a la visita de selección) documentados de respuesta inadecuada a un tratamiento suficiente con uno o varios medicamentos tópicos para la DA o para los cuales las terapia de DA tópica es medicamente desaconsejable.
    E.4Principal exclusion criteria
    1. Prior treatment with dupilumab
    2. Recent treatment (within specific time windows before the baseline
    visit) with systemic corticosteroids, immunosuppressive agents, topical
    corticosteroids and calcineurin inhibitors, live (attenuated) vaccine,
    other investigational drugs
    3. History of human immunodeficiency virus (HIV) infection
    4. HIV or viral hepatitis seropositivity at screening
    5. Known or suspected immunosuppresion
    6. Recent infections requiring antiinfectious treatment
    7. Recent history or high risk of clinical endoparasitoses
    8. High risk populations (low life expectancy, severe concomitant
    diseases, etc.)
    9. Pregnant or breast-feeding women
    10. Patients of reproductive potential and sexually active who are
    unwilling to use adequate contracepcion.
    1. Participación previa en un ensayo clínico con dupilumab.
    2. Tratamiento reciente con corticoides sistemicos, agentes inmunosupresores, corticosteroides tópicos e inhibidores de la calceneurina, vacunas vivas (atenuadas), otros fármacos en investigación.
    3. Historia de infección por el virus del VIH.
    4. Hepatitis viral o VIH seropositivo en el screening.
    5. Sopecha o Inmunosupresión conocida.
    6. Infecciones recientes que requiren tratamiento antiinfeccioso.
    7. Historia reciente o alto riesgo de endoparasitosis clínica.
    8. Poblaciones de alto riesgo (esperanza de vida baja, enfermedades concomitantes graves, etc...).
    9. Mujeres embarazadas o en periodo de lactancia.
    10. Pacientes con potencial reproductivo y sexualmente activos los cuales no desean usar métodos anticonceptivos adecuados
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of patients with EASI-50 response (reduction of EASI score by at least 50% from baseline) at week 12.
    - Percentage of patients with IGA 0 or 1 at week 12
    - Porcentaje de pacientes que alcanzan una respuesta EASI 50 (reducción de un 50%, como mínimo, de la puntuación EASI respecto a la situación basal) en la semana 12.
    - Porcentaje de pacientes con una VGI de 0 o 1 en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    - The change from baseline in maximum itch intensity (NRS) at week 12
    - The change from baseline in BSA at week 12
    - The change from baseline in the erythema of GISS at week 12
    - The change from baseline in the infiltration/papulation of GISS at week 12
    - The change from baseline in the excoriations of GISS at week 12
    - The change from baseline in the lichenification of GISS at week 12
    - Percentage of patients achieving EASI-50 response (reduction of EASI
    score by at least 50% from baseline) at week 12 and maintaining EASI-50 response on at least 6 of the10 subsequent every 4 weeks (q4w) visits (from visits at weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52); 1 of the 6 must be in the last 4 visits (weeks 40, 44,
    48 and 52).
    - Percentage of patients with IGA 0 to 1 at week 12 and maintaining IGA 0 to 2 on at least 6 of the10 subsequent q4w visits (from visits at weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52); 1 of the 6 must be in the last 4 visits (weeks 40, 44, 48 and 52).
    - The change from baseline in oozing/crusting at week 12
    - Incidence of serious treatment-emergent adverse events (TEAEs)
    through week 56
    - Incidence of study drug discontinuation due to an AE through week 56.
    - Incidence of skin-infections through week 56
    - Cambio en la intensidad máxima del prurito (ENV) en la semana 12 respecto a la situación basal.
    - Cambio en la SCDA en la semana 12 respecto a la situación basal.
    - Cambio en el eritema de la puntuación GISS en la semana 12 respecto a la situación basal
    - Cambio en la infiltración/presencia de pápulas de la puntuación GISS en la semana 12 respecto a la situación basal
    -Cambio en las excoriaciones de la puntuación GISS en la semana 12 respecto a la situación basal
    -Cambio en la liquenificación de la puntuación GISS en la semana 12 respecto a la situación basal.
    - Porcentaje de pacientes que alcanzan una respuesta EASI 50 (reducción de la puntuación EASI en un 50% como mínimo respecto a la situación basal) en la semana 12 y que posteriormente mantienen la respuesta EASI 50 en 6 de las 10 visitas subsiguientes (efectuadas cada 4 semanas: visitas de las semanas 16, 20, 24, 28, 32, 36, 40, 44, 48 y 52) como mínimo; una de las seis visitas deberá ser obligatoriamente una de las cuatro últimas (semanas 40, 44, 48 y 52).
    -Porcentaje de pacientes con una VGI de 0 ó 1 en la semana 12 y que posteriormente mantienen una VGI de 0 a 2 en 6 de las 10 visitas subsiguientes (efectuadas cada 4 semanas: visitas de las semanas 16, 20, 24, 28, 32, 36, 40, 44, 48 y 52) como mínimo; una de las seis visitas deberá ser obligatoriamente una de las cuatro últimas (semanas 40, 44, 48 y 52).
    -Cambio en los exudados/costras en la semana 12 respecto a la situación basal.
    -Incidencia de acontecimientos adversos graves observados durante el tratamiento (AAOT) hasta la semana 56
    -Incidencia de suspensiones del fármaco del estudio debido a AA hasta la semana 56
    -Incidencia de infecciones cutáneas hasta la semana 56
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 12
    2) Week 12.
    3) Week 12.
    4) Week 12.
    5) Week 12.
    6) Week 12.
    7) Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52.
    8) Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52.
    9) Week 12.
    10) Week 56
    11) Week 56
    12) Week 56
    10) Week 56
    11) Week 56
    12) Week 56.
    1) Semana 12.
    2) Semana 12.
    3) Semana 12.
    4) Semana 12.
    5) Semana 12.
    6) Semana 12.
    7) Semana 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, y semana 52.
    8) Semana 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, y semana 52.
    9) Semana 12.
    10) Semana 56.
    11) Semana 56.
    12) Semana 56.
    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 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 trial3
    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 EEA105
    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
    Australia
    Belgium
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Korea, Republic of
    Latvia
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    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
    Last Patient Last Visit
    Último Paciente Última Visita
    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 months3
    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 months8
    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: 382
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 450
    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)
    Patients who complete this study may be eligible to enroll in an openlabel extension study.
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-19
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