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    Summary
    EudraCT Number:2013-001449-15
    Sponsor's Protocol Code Number:R668-AD-1225
    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:2015-04-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-001449-15
    A.3Full title of the trial
    AN OPEN-LABEL STUDY OF DUPILUMAB IN PATIENTS WITH ATOPIC DERMATITIS WHO PARTICIPATED IN PREVIOUS DUPILUMAB CLINICAL TRIALS
    ESTUDIO ABIERTO DE DUPILUMAB EN PACIENTES CON DERMATITIS ATÓPICA QUE HAN PARTICIPADO EN ENSAYOS CLÍNICOS PREVIOS CON DUPILUMAB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the long-term safety of dupilumab administered in adult patients with atopic dermatitis (AD)
    Estudio para evaluar la seguridad de dupilumab a largo plazo administrado a pacientes adultos con dermatitis atópica (AD).
    A.4.1Sponsor's protocol code numberR668-AD-1225
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01949311
    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+34934978913
    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 REGN668/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.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeREGN668/SAR231893
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    Dermatitis atópica
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis / Eczema
    Dermatitis atópica/ Eccema
    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 17.1
    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
    The primary objective is to assess the long-term safety of dupilumab administered in adult patients with AD.
    El objetivo principal es evaluar la seguridad a largo plazo de dupilumab en pacientes adultos con dermatitis atópica (DA).
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the immunogenicity of dupilumab in adult patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
    El objetivo secundario es evaluar la inmunogenia de dupilumab en pacientes adultos con DA, en el contexto de su re-tratamiento, y evaluar los parámetros de eficacia en el tratamiento a largo plazo.
    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:
    The purpose of the genomic analyses is to identify genomic associations with clinical or biomarker response to IL4-R alpha inhibition, immunology, inflammation, eosinophil driven diseases, and atopic diseases.
    Subestudio genómico opcional:
    El objetivo del análisis genómico es identificar eventuales asociaciones genómicas con la respuesta clínica o de biomarcadores a la inhibición de IL4-R alfa, con la inmunología, la inflamación, las enfermedades eosinofílicas y enfermedades atópicas.
    E.3Principal inclusion criteria
    A patient must meet the following criteria to be eligible for inclusion in the study:
    1. Underwent study treatment in a prior clinical trial of dupilumab for AD and met one of the following:
    a. Adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols; specifically, patients must complete the primary endpoint visit and at least
    50% of the scheduled in-clinic visits and at-home assessments*). Patients who discontinued a parent study prematurely (ie, patients who did not complete the protocol-defined end-of-study visit) cannot enroll into this open-label extension study before the date when the end-of-study visit would have normally occurred. Completion of the entire follow-up period is not required for parent studies where the protocol specifically allows for an earlier transition into the open-label extension, in which case these requirements apply up to the point of this early transition.
    * For at-home assessments (eg, patient reported outcomes by IVRS calls), patients who completed less than 50% of the assessments may be eligible if technical issues (eg, IVRS system malfunction) or other documented objective circumstances
    contributed to missing assessments.
    b. Received study treatment in one the following studies: R668-AD-0914, R668-AD-1026, R668-AD-1117, and R668-AD-1121, irrespective of duration of participation, provided that patients complied with their investigator?s instructions.
    2. Must be >or=18 years of age at screening
    3. Willing and able to comply with all clinic visits and study-related procedures
    4. Able to understand and complete study-related questionnaires
    5. Provide signed informed consent
    Un paciente debe cumplir los siguientes criterios para ser considerado elegible para la inclusión en el estudio:

    1. Haber recibido el tratamiento del estudio en un ensayo clínico previo con dupilumab en la DA y cumplir uno de los siguientes:

    a. Haber completado adecuadamente las evaluaciones necesarias de los períodos de tratamiento y de seguimiento del estudio original (excepto los estudios señalados en b), de acuerdo a su definición en dicho protocolo original; en concreto, los pacientes deberán haber completado la visita de valoración principal y como mínimo el 50% de las visitas programadas al centro y de las evaluaciones domiciliarias*). Además, los pacientes que hubieran abandonado prematuramente el estudio original (es decir, los pacientes que no hayan completado la visita de fin del estudio definida por el protocolo) no podrán participar en este estudio de extensión abierto antes de la fecha en la que hubiera tenido lugar normalmente su visita de fin del estudio. No se precisa que hayan completado todo el período de seguimiento en el caso de aquel estudio original en el que el protocolo permita específicamente la transición del paciente a la extensión abierto, en cuyo caso estos requisitos sólo serán aplicables hasta donde lo permita esta transición prematura.
    *En cuanto a las evaluaciones domiciliarias (por ejemplo, desenlaces comunicados por los pacientes a través del IVRS), podrían ser elegibles los pacientes que hayan completado menos del 50% de las evaluaciones si ello se debiera a problemas técnicos (por ejemplo, mal funcionamiento del sistema IVRS) u otras circunstancias objetivas documentadas.
    b. Haber recibido tratamiento en uno de los siguientes estudios: R668-AD-0914, R668-AD-1026, R668-AD-1117, R668-AD-1021 y R668-AD-1121, independientemente de la duración de su participación, siempre que el paciente haya cumplido con las instrucciones recibidas durante el estudio, a juicio del investigador.

    2. Edad: >o=18 años en el momento de la selección.
    3. Deseo y capacidad de cumplir con todas las visitas clínicas y las intervenciones relacionadas con el estudio.
    4. Capacidad de comprender y responder a los cuestionarios del estudio.
    5. Firma del consentimiento informado por escrito.
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from the study:
    1. Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
    2. Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
    3. Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
    *Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
    4. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit.
    5. Treatment with immunosuppressive/immunomodulating drugs (eg, cyclosporine, mycophenolate-mofetil, IFN-?, azathioprine, methotrexate, JAK inhibitors) within 1 week before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment in the current study.
    6. Treatment with immunomodulating biologics, other than dupilumab, within 5 half-lives (if known) or 16 weeks (whichever is longer) before the first dose in the open-label extension study.
    7. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
    8. Planned or anticipated use of any prohibited medications and procedures during study treatment.
    9. Active chronic or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before day 1 visit, or superficial skin infections within 1 week before the screening visit. NOTE: patients may be rescreened after the infection resolves.
    10. Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency as judged by the investigator.
    11. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity (HIV testing is not required at screening for patients with a negative HIV result within the past 1 year prior to baseline).
    12. Known history of positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HBsAg or hepatitis C testing is not required at screening for patients with a negative result within the past 1 year prior to baseline).

    Exclusion criteria 13-23 (see study protocol)
    Se excluirá del estudio a todo paciente que cumpla cualquiera de los siguientes criterios:
    1. Paciente que, durante su participación en un ensayo clínico previo con dupilumab, haya desarrollado un acontecimiento adverso grave (AAG) que se consideró relacionado con dupilumab* y que, en opinión del investigador o el monitor médico, pudiera indicar que la continuación del tratamiento con dupilumab supondría un riesgo injustificado para el paciente.
    2. Paciente que, durante su participación en un ensayo clínico previo con dupilumab, haya desarrollado un acontecimiento adverso (AA) que se consideró relacionado con dupilumab* lo que le llevó a abandonar del tratamiento y que, en opinión del investigador o del monitor médico, pudiera indicar que la continuación del tratamiento con dupilumab supondría un riesgo injustificado para el paciente.
    3. Procesos en el estudio previo con dupilumab compatibles con los criterios definidos por el protocolo para el abandono definitivo del fármaco del estudio, si se hubieran considerado relacionados dupilumab* o que hubieran llevado a la retirada del paciente

    del estudio por parte del investigador o del promotor (por ejemplo, falta de cumplimiento, incapacidad de completar las evaluaciones del estudio, etc.).
    *Nota acerca de los criterios de exclusión 1, 2 y 3: En los estudios cuyo código aún no se haya abierto, los procesos que se consideren relacionados con el tratamiento del estudio se considerarán relacionados con dupilumab.
    4. Tratamiento con un fármaco en fase de investigación (distinto del dupilumab) en un plazo de 8 semanas o en un plazo de 5 semividas (en el caso de que esta se conozca), optando de entre ambos por el más prolongado, antes de la visita basal.
    5. Tratamiento con fármacos inmunodepresores/inmunomoduladores (por ejemplo, ciclosporina, micofenolato mofetilo, IFN-gamma, azatioprina, metotrexato, inhibidores de JAK) dentro del plazo de 1 semana antes de la visita basal o cualquier proceso que, en opinión del investigador es probable que vaya a precisar un tratamiento de este tipo durante las 4 primeras semanas del tratamiento en el presente estudio.
    6. Tratamiento con agentes biológicos inmunomoduladores, distintos del dupilumab, en el plazo de 5 semividas (en el caso de que esta se conozca) o 16 semanas (optando por el más prolongado de estos plazos) antes de la primera dosis del estudio de extensión abierto.
    7. Tratamiento con una vacuna de gérmenes vivos (atenuados) en un plazo de 12 semanas antes de la visita basal
    8. Uso programado o previsible de un medicamento o procedimiento prohibido durante el tratamiento del estudio.
    9. Infección crónica o aguda activa que requiera tratamiento sistémico con antibióticos, antivirales, antiparasitarios, antiprotozoarios o antifúngicos en un plazo de 2 semanas antes de la visita del día 1, o infecciones cutáneas superficiales en un plazo de 1 semana antes de la visita de selección. NOTA: los pacientes pueden ser examinados de nuevo para su posible inclusión una vez resuelta la infección.
    10. Conocimiento o sospecha de inmunodeficiencia, lo que incluye la historia de infecciones oportunistas invasivas (por ej., tuberculosis, histoplasmosis, listeriosis, coccidioidomicosis, pneumocistosis, aspergillosis) a pesar de la resolución de la infección, o de otras infecciones recurrentes de frecuencia anormal en opinión del investigador.
    11. Conocimiento de infección por el virus de la inmunodeficiencia humana (VIH) o de seropositividad del VIH (no se precisa la prueba del VIH en la selección en los pacientes con resultado negativo en una prueba del VIH dentro del año anterior al momento basal).
    12. Antecedente conocido de positividad del antígeno de superficie de la hepatitis B (HBsAg), del anticuerpo contra el antígeno central de la hepatitis B (HBcAb) o del anticuerpo de la hepatitis C. No se precisa estudio de la hepatitis en la selección en los pacientes con resultado negativo dentro del año anterior al momento basal.
    Para los criterios 13-23 véase protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the study is the incidence and rate (events per patient-year) of treatment-emergent adverse events (TEAEs) through the last study visit.
    El criterio de valoración principal es la incidencia y la tasa (acontecimientos por pacientes-año) de acontecimientos adversos surgidos durante el tratamiento (AAST) hasta la última visita del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    Durante toda la duración del estudio
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    - Incidence and rate (events per patient-year) of SAEs and AEs of special interest
    - Proportion of patients with IGA = 0-1 at each visit
    - Proportion of patients with EASI-75 (>75% reduction from baseline in EASI scores) at each visit
    - Incidencia y tasa (acontecimientos por pacientes-año) de acontecimientos adversos graves (AAG) y acontecimientos adversos (AA) de especial interés
    - Porcentaje de pacientes con un valor de la Investigator?s Global Assessment (IGA) de 0-1 en cada visita
    - Porcentaje de pacientes con un valor del Eczema Area and Severity Index (EASI) -75 (reducción frente al basal >75% en la puntuación del EASI) en cada visita
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    Durante toda la duración del estudio
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.8.3 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Lithuania
    New Zealand
    Poland
    Singapore
    Spain
    Sweden
    United Kingdom
    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
    Last patient last visit
    Última visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 680
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 800
    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)
    Standard care of treatment
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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