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    Summary
    EudraCT Number:2018-001543-30
    Sponsor's Protocol Code Number:R3500-AD-1798
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 number2018-001543-30
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF REGN3500 MONOTHERAPY AND COMBINATION OF REGN3500 PLUS DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Estudio de fase 2a, aleatorizado, en doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de REGN3500 en monoterapia y en combinación con dupilumab en pacientes adultos con dermatitis atópica moderada o severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study in Adult Patients with Moderate to Severe Atopic Dermatitis
    Estudio de seguridad y eficacia en pacientes adultos con dermatitis atópica de moderada o severa
    A.4.1Sponsor's protocol code numberR3500-AD-1798
    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 Trial Management
    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.5.6E-mailclinicaltrials@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 nameREGN3500
    D.3.4Pharmaceutical form Lyophilisate for 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 INNREGN3500
    D.3.9.3Other descriptive nameREGN3500
    D.3.9.4EV Substance CodeSUB182669
    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) 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 Yes
    D.2.1.1.1Trade name Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    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 codeREGN668
    D.3.9.3Other descriptive nameSAR231893
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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
    Moderate to Severe Atopic Dermatitis
    Dermatitis atópica moderada o severa
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Atopic Dermatitis
    Dermatitis atópica moderada o severa
    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 20.0
    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
    The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe atopic dermatitis (AD).
    El objetivo principal del estudio es evaluar la eficacia de REGN3500 en monoterapia comparado con placebo en pacientes adultos con dermatitis atópica (atopic dermatitis, AD) moderada o severa.
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD
    -To assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD
    -To evaluate the pharmacokinetics (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD
    -Evaluar la eficacia de REGN3500 en combinación con dupilumab comparado con placebo en pacientes adultos con dermatitis atópica moderada o severa
    -Evaluar la seguridad, tolerabilidad e inmunogenia de dosis subcutáneas (SC) de REGN3500 en monoterapia y de REGN3500 en combinación con dupilumab en pacientes adultos con dermatitis atópica moderada o severa
    -Evaluar la farmacocinética (pharmacokinetics, PK) de REGN3500 en monoterapia y de REGN3500 en combinación con dupilumab en pacientes adultos con dermatitis atópica moderada o severa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 years or older
    2. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit
    3. EASI score >=16 at the screening and baseline visits
    4. IGA score >=3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits
    5. >=10% BSA of AD involvement at the screening and baseline visits
    6. Baseline peak Pruritus NRS score for maximum itch intensity >=4
    7. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable (eg, intolerance, because of important side effects, or safety risks).
    8. Have applied a stable dose of topical bland emollient (moisturizer) at least twice daily for at least the 7 consecutive days immediately before randomization
    9. Willing and able to comply with all clinic visits and study-related procedures
    10. Provide informed consent signed by study patient or legally acceptable representative
    11. Able to understand and complete study-related questionnaires
    1. Hombre o mujer, de como mínimo 18 años
    2. Dermatitis atópica crónica, según los American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), presente durante como mínimo los 3 años anteriores a la visita de selección (screening)
    3. Puntuación del EASI >=16 en las visitas de selección y basal (baseline)
    4. Puntuación de la IGA >=3 (en la escala IGA de 0 a 4, en la que 3 es grado moderado y 4 es grado severo) en las visitas de selección y basal
    5. Afectación por la dermatitis atópica >=10% de la superficie corporal (body surface area, BSA) en las visitas de selección y basal
    6. Puntuación del pico de la escala Pruritus NRS correspondiente a una intensidad máxima del picor >=4 en la visita basal
    7. Historia reciente documentada (en el plazo de los 6 meses anteriores a la visita de selección) de respuesta inadecuada a uno o más medicamentos tópicos para la dermatitis atópica o enfermedad en la que no son recomendables médicamente los tratamientos tópicos (por ejemplo, por intolerancia, importantes efectos secundarios o riesgo de seguridad)
    8. El paciente se ha aplicado una dosis estable de un emoliente (hidratante) suave tópico al menos dos veces al día durante como mínimo los 7 días inmediatamente anteriores a la aleatorización
    9. Voluntad de y capacidad para cumplir con todas las visitas clínicas y los procedimientos del estudio
    10. Firma del consentimiento informado por el paciente del estudio o por su representante legal
    11. Capacidad para comprender y rellenar los cuestionarios del estudio
    E.4Principal exclusion criteria
    1. Prior participation in a REGN3500 (anti-IL-33) or dupilumab (anti-IL-4Rα) clinical study; past treatment with or current treatment with dupilumab
    2. Body mass index <16 kg/m2
    3. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
    4. Having used any of the following treatments within 4 weeks 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: Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc) Phototherapy for AD
    5. Treatment with TCS, TCI, or topical crisaborole within 1 week before the baseline visit
    6. Treatment with biologics as follows: Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
    7. Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period
    8. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
    9. Planned or anticipated use of any prohibited medications and procedures during study treatment
    10. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
    11. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit
    12. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
    13. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
    14. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
    15. At baseline, presence of any conditions listed as criteria for study drug discontinuation
    16. Presence of skin comorbidities that may interfere with study assessments
    17. History of cancer, with the exceptions of: Patients with adequately treated basal cell carcinoma or carcinoma in situ of the
    cervix. Patients with other malignancies that have been successfully treated for >10 years prior to screening where, in the judgement of both the investigator and the treating physician, appropriate follow-up has revealed no evidence of recurrence through time of screening.
    18. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
    19. History of alcohol or drug abuse within 2 years of the screening visit
    20. Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study.
    21. Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient’s participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents
    22. Planned or anticipated major surgical procedure during the patient’s participation in this study
    23. Patient is a member of the investigational team or his/her immediate family
    24. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
    25. Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 20 weeks after the last dose of study drug.
    26. Known sensitivity to doxycycline and/or tetracycline or to any of the components of the investigational product formulation
    27. Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities will be excluded from this study (as required by country regulations).
    1. Participación previa en un estudio clínico con REGN3500 (anti-IL-33) o con dupilumab (anti-IL-4Rα); tratamiento anterior o actual con dupilumab
    2. Índice de masa corporal <16 kg/m2
    3. Tratamiento con un fármaco en fase de investigación en el plazo de las 8 semanas o 5 semividas (si se conoce este dato) del producto, eligiéndose el mayor de estos períodos, antes de la visita basal
    4. Recepción de cualquiera de los siguientes tratamientos en el plazo de las 4 semanas anteriores a la visita basal o cualquier proceso que, en opinión del investigador, es probable que pueda necesitar un tratamiento de ese tipo durante las 4 primeras semanas del tratamiento del estudio:
    Inmunosupresores/inmunomoduladores (por ejemplo, corticosteroides sistémicos, ciclosporina, micofenolato mofetilo, IFN-γ, inhibidores de la cinasa Jano, azatioprina, metotrexato, etc.)
    Fototerapia para la dermatitis atópica
    5. Tratamiento con corticosteroides tópicos (TCS), inhibidores de la calcineurina tópicos (TCI) o crisaborol tópico en el plazo de 1 semana antes de la visita basal
    6. Tratamiento con agentes biológicos de la siguiente forma:
    Cualquier agente citorreductor, tal como, entre otros, rituximab: en el plazo de los 6 meses anteriores a la visita basal o hasta que la cifra de linfocitos haya vuelto a la normalidad, eligiéndose el mayor de estos plazos
    Otros agentes biológicos: en el plazo de 5 semividas (si se conoce este dato) o 16 semanas antes de la visita basal, eligiéndose el mayor de estos plazos
    7. Comienzo de tratamiento para la dermatitis atópica con hidratantes a obtener con receta o que contienen aditivos como ceramida, ácido hialurónico, urea o productos de degradación de la filagrina, durante el período de selección (los pacientes pueden continuar con dosis estables de estos hidratantes si los han iniciado antes de la visita de selección)
    8. Uso regular (más de 2 visitas a la semana) de cabina/salón de bronceado en el plazo de las 4 semanas anteriores a la visita basal
    9. Uso programado o previsible de medicamentos y procedimientos prohibidos durante el tratamiento del estudio
    10. Recepción de una vacuna de gérmenes vivos (atenuados) en el plazo de las 12 semanas anteriores a la visita basal
    11. Infección crónica o aguda activa que precisa tratamiento con antibióticos sistémicos, antivíricos, antiparasitarios, antiprotozoarios o antifúngicos en el plazo de las 2 semanas anteriores a la visita basal, o infección cutánea superficial en el plazo de 1 semana antes de la visita basal
    NOTA: una vez resuelta la infección, el paciente podrá ser sometido de nuevo a los exámenes de selección
    12. Conocimiento o sospecha de antecedentes de inmunosupresión, tal como infección oportunista invasiva (por ejemplo, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidosis, neumocistosis, aspergilosis), aunque se haya resuelto la infección; o infecciones inusualmente frecuentes, recurrentes o prolongadas en opinión del investigador
    13. Infección por el virus de la inmunodeficiencia humana (HIV) o positividad de la serología del HIV en la visita de selección
    14. Positividad del antígeno de superficie de la hepatitis (HBsAg), del anticuerpo core de la hepatitis B (HBcAb) o del anticuerpo contra el virus de la hepatitis C (HCV Ab) en la visita de selección
    15. Presencia en el momento basal de cualquiera de los procesos listados en los criterios para la retirada del fármaco del estudio
    16. Presencia de otros procesos cutáneos que pudieran interferir en las evaluaciones del estudio
    17. Antecedentes de cáncer, con la excepción de:
    Carcinoma cutáneo de células basales o carcinoma in situ de cuello uterino tratados adecuadamente
    Otros procesos malignos tratados con éxito >10 años antes de la visita de selección y que, según el investigador y el médico responsable del paciente, su seguimiento adecuado no ha mostrado evidencia alguna de recidiva en el momento de la visita de selección
    18. Diagnóstico de infección endoparasitaria activa; sospecha o alto riesgo de infección endoparasitaria, salvo si los datos clínicos y (si es preciso) de laboratorio descartaran infección activa antes de la aleatorización
    19. Antecedentes de alcoholismo o drogadicción en el plazo de los 2 años anteriores a la visita de selección
    20. Enfermedad o enfermedades concomitantes severas que, en opinión del investigador, pudieran afectar negativamente a la participación del paciente en el estudio.

    Para el resto de criterios vease el protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the study is the percent change in EASI score from baseline to week 16.
    El criterio de valoración principal del estudio es el cambio porcentual en la puntuación EASI desde el momento basal hasta la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    -Proportion of patients achieving EASI-50, EASI-75, and EASI-90 (≥50%, ≥75%, and ≥90% improvement from baseline) at week 16
    -Absolute change in EASI score from baseline to week 16
    -Proportion of patients with both an Investigator’s Global Assesssment (IGA) score of 0 or 1 (on a 5-point scale) and a reduction from baseline of ≥2 points at week 16
    -Change (absolute and percent) from baseline to week 16 in weekly average of daily peak Pruritus Numerical Rating Scale (NRS)
    -Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4 from baseline at week 16
    -Time to onset of effect on pruritus during the 16-week treatment period (≥4-point reduction of weekly average of daily peak Pruritus NRS from baseline)
    -Percent change from baseline to week 16 in SCORing Atopic Dermatitis (SCORAD)
    -Change from baseline to week 16 in percent body surface area (BSA) of AD involvement

    Safety:
    -Incidence of treatment-emergent adverse events (TEAEs) from baseline through end of treatment (week 16)
    -Incidence of treatment-emergent serious adverse events (SAEs) from
    baseline through end of treatment (week 16)
    -Incidence of treatment-emergent adverse events of special interest
    (AESIs) from baseline through end of treatment (week 16)
    -Incidence of TEAEs from baseline through end of study (week 36)
    -Incidence of treatment-emergent SAEs from baseline through end of
    study (week 36)
    -Incidence of treatment-emergent AESIs from baseline through end of
    study (week 36)
    PK:
    -Concentrations of functional REGN3500 and functional dupilumab in
    serum by treatment regimen at each assessment time point from
    baseline to end of study (week 36)
    -Porcentaje de pacientes que alcanzan EASI-50, EASI-75 y EASI-90 (mejoría =>50%,=>75% y =>90% frente al basal) en la semana 16.
    -Cambio absoluto en la puntuación EASI desde el momento basal hasta la semana 16.
    Porcentaje de pacientes con una puntuación Investigator’s Global Assessment (IGA) de 0 o 1 (en una escala de 5 puntos) y también con una reducción frente al basal ≥2 puntos en la semana 16
    -Cambio (absoluto y porcentual) desde el momento basal hasta la semana 16 en el valor semanal promedio del pico diario de la Pruritus Numerical Rating Scale (NRS)
    -Porcentaje de pacientes con mejoría (reducción) del valor semanal promedio del pico diario de la escala Pruritus NRS ≥4 desde el momento basal hasta la semana 16
    -Tiempo hasta el inicio del efecto sobre el prurito durante el periodo de tratamiento de 16 semanas (reducción ≥4 puntos del valor semanal promedio del pico diario de la escala Pruritus NRS frente al basal)
    -Cambio porcentual desde el momento basal hasta la semana 16 en SCORing Atopic Dermatitis (SCORAD)
    -Cambio desde el momento basal hasta la semana 16 en el porcentaje de área de superficie corporal (body surface area, BSA) afectada por la dermatitis atópica
    Seguridad
    -Incidencia de eventos adversos emergentes del tratamiento (TEAEs) desde el inicio hasta el final del tratamiento (semana 16)
    -Incidencia de eventos adversos graves emergentes del tratamiento desde el inicio hasta el final del tratamiento (semana 16)
    -Incidencia de eventos adversos emergentes de tratamiento de interés especial (EASI) desde el inicio hasta el final del tratamiento (semana 16). -Incidencia de TEAE desde el inicio hasta el final del estudio (semana 36)
    -Incidencia de eventos adversos graves emergentes de tratamiento desde el inicio hasta el final del estudio (semana 36)
    -Incidencia de AESI emergente de tratamiento desde el inicio hasta el final del estudio (semana 36).
    PK:
    -Concentraciones de REGN3500 funcional y dupilumab funcional en suero por régimen de tratamiento en cada momento de evaluación desde el inicio al final de estudio (semana 36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 EEA45
    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
    Czech Republic
    Germany
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study is defined as the date on which last subject completes the last visit
    El fin del estudio se define como la fecha en la que el ultimo paciente completa la última visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 280
    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 Decision2019-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-02-12
    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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