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    Summary
    EudraCT Number:2018-001544-64
    Sponsor's Protocol Code Number:R3500-AD-1805
    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 number2018-001544-64
    A.3Full title of the trial
    A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY INVESTIGATING THE EFFICACY, SAFETY, AND PHARMACOKINETIC PROFILES OF REGN3500 ADMINISTERED TO ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Estudio de fase 2b, aleatorizado, en doble ciego, controlado con placebo, de grupos paralelos y de búsqueda de dosis, para investigar los perfiles de eficacia, seguridad y farmacocinética de REGN3500 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, Efficacy and Pharmacokinetic Study in Adult Patients with Moderate to Severe Atopic Dermatitis
    Estudio de seguridad, eficacia y farmacocinética en pacientes adultos con dermatitis atópica moderada a grave
    A.4.1Sponsor's protocol code numberR3500-AD-1805
    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.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
    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 de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Atopic Dermatitis
    Dermatitis atópica de moderada a grave
    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 assess the efficacy of REGN3500 monotherapy in atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD.
    El objetivo principal del estudio es evaluar la eficacia de REGN3500 en monoterapia, y examinar la relación dosis-respuesta, en comparación con placebo, en pacientes adultos con dermatitis atópica (atopic dermatitis, AD) moderada o severa.
    E.2.2Secondary objectives of the trial
    -To assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD
    -To assess the pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD
    -To assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD
    -Evaluar la seguridad y la tolerabilidad de la administración subcutánea (SC) de REGN3500 en monoterapia en pacientes adultos con dermatitis atópica moderada o severa
    -Evaluar la farmacocinética (pharmacokinetics, PK) de REGN3500 en pacientes adultos con dermatitis atópica moderada o severa
    -Evaluar la inmunogenia de REGN3500 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 to 75 years
    2. Chronic AD, according to American Academy of Dermatology Consensus Criteria 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 the baseline visit (ie, baseline/randomization visit would be the eighth day; see exclusion criterion 7 regarding restrictions on the kind of emollients permitted during the study).
    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 18 a 75 años
    2. Dermatitis atópica crónica, según los American Academy of Dermatology Consensus Criteria, presente durante como mínimo los 3 años anteriores a la visita de selección
    3. Puntuación EASI ≥16 en las visitas de selección y basal
    4. Puntuación IGA ≥3 (en la escala IGA de 0 a 4, en la que 3 significa moderada y 4 significa severa) en las visitas de selección y basal
    5. BSA (área de superficie corporal) afectada por la dermatitis atópica ≥10% en las visitas de selección y basal
    6. Puntuación de prurito NRS equivalente a una intensidad máxima del picor ≥4 en el momento 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 están recomendados médicamente los tratamientos tópicos (por ejemplo, por intolerancia, importantes efectos secundarios o riesgos de seguridad).
    8. El sujeto se ha aplicado una dosis estable de una crema hidratante (emoliente suave) como mínimo dos veces al día durante como mínimo los 7 días consecutivos inmediatamente anteriores a la visita basal (es decir, la visita basal/aleatorización tendría lugar en el octavo día; véase el criterio de exclusión 7, acerca de las restricciones sobre el tipo de emolientes que se permiten durante el estudio).
    9. Voluntad de y capacidad para cumplir con todas las visitas al centro y con 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. Participation in a prior anti-IL-33 class medication clinical study
    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 (including dupilumab): 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
    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 them 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. Examples include, but are not limited to, patients with short life expectancy, patients with uncontrolled diabetes (hemoglobin A1c [HbA1c] ≥9%), patients with uncontrolled cerebrocardio vascular conditions (eg, myocardial infarction [MI], unstable arterial hypertension, unstable angina, cerebrovascular accident, and stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepatobiliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg., demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc), other severe endocrinological, gastrointestinal,
    metabolic, pulmonary, or lymphatic diseases.
    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, .
    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
    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 en un estudio clínico previo con un medicamento anti-IL-33
    2. Índice de masa corporal <16 kg/m2
    3. Tratamiento con un medicamento en fase de investigación en el plazo de las 8 semanas o 5 semividas (si se conoce la semivida) anteriores a la visita basal, eligiéndose el mayor de estos periodos
    4. Utilización de los siguientes tratamientos en el plazo de las 4 semanas anteriores a la visita basal o presencia de cualquier proceso que, en opinión del investigador, es probable que precise dicho o dichos tratamientos durante las 4 primeras semanas del tratamiento del estudio: fármacos 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, inhibidores de la calcineurina tópicos o crisaborol tópico en el plazo de 1 semana antes de la visita basal
    6. Tratamiento con agentes biológicos de la siguiente manera:
    Cualquier agente citorreductor , tal como, entre otros, el rituximab: en el plazo de los 6 meses anteriores a la visita basal o hasta que la cifra de linfocitos vuelva a la normalidad, eligiéndose el mayor de estos periodos. Otros agentes biológicos (incluido el dupilumab): en el plazo de 5 semividas (si se conoce su semivida) o 16 semanas antes de la visita basal, eligiéndose el mayor de estos periodos
    7. Inicio de un tratamiento para la dermatitis atópica con cremas hidratantes a obtener con receta o que contienen aditivos como ceramida, ácido hialurónico, urea o productos de degradación de la filagrina, durante el periodo de selección
    8. Uso regular (más de 2 veces a la semana) de cabina/centro de bronceado en el plazo de las 4 semanas anteriores a la visita basal
    9. Uso programado o previsto de cualquier medicamento o procedimiento prohibidos durante el tratamiento del estudio
    10. Vacuna con gérmenes vivos (atenuados) en el plazo de las 12 semanas anteriores a la visita basal
    11. Infección crónica o aguda activa que requiere tratamiento con antibióticos sistémicos, antivirales, antiparasitarios, antiprotozoarios o antifúngicos en el plazo de las 2 semanas anteriores a la visita basal, o infecciones cutáneas superficiales en el plazo de 1 semana antes de la visita basal.
    12. Conocimiento o sospecha de antecedente de inmunosupresión, incluida la historia de infecciones oportunistas invasoras
    13. Historia de infección por el virus de la inmunodeficiencia humana (HIV) o positividad de la serología del HIV en la selección
    14. Positividad del antígeno de superficie de la hepatitis B (HBsAg), del anticuerpo core de la hepatitis B (HBcAb) o del anticuerpo frente al virus de la hepatitis C (HCV Ab) en la visita de selección
    15. Presencia en el momento basal de cualquier proceso listado en los criterios para la suspensión del fármaco del estudio
    16. Presencia de otros procesos cutáneos que puedan interferir en las evaluaciones del estudio
    17. Antecedentes de cáncer, con la excepción de:
    -Pacientes con carcinoma de células basales o carcinoma in situ de cuello uterino adecuadamente tratados
    -Pacientes con otros procesos malignos tratados con éxito >10 años antes de la selección y que, en opinión tanto del investigador como del médico que los trató, un seguimiento adecuado no ha revelado evidencia de recidiva en el momento de la selección.
    18. Diagnóstico de infección endoparasitaria activa; sospecha o alto riesgo de infección endoparasitaria, salvo si las evaluaciones clínicas y (si fuera necesario) de laboratorio descartaran la presencia de infección activa antes de la aleatorización
    19. Antecedente 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, tal como, entre otras situaciones: pacientes con corta esperanza de vida, diabetes no controlada (hemoglobina A1c [HbA1c] ≥9%), procesos vasculares cerebrales/cardíacos no controlados (por ejemplo, infarto de miocardio, hipertensión arterial no controlada, angina inestable, accidente cerebrovascular e insuficiencia cardíaca en estadio III o IV de la clasificación de la New York Heart Association), enfermedades renales severas (por ejemplo, pacientes en diálisis), procesos hepatobiliares (por ejemplo, clase B o C de Child-Pugh), procesos neurológicos (por ejemplo, enfermedades desmielinizantes), enfermedades autoinmunitarias mayores activas (por ejemplo, lupus, enfermedad intestinal inflamatoria, artritis reumatoide, etc.), otras enfermedades severas de carácter endocrinológico, gastrointestinal, metabólico, pulmonar o linfático.
    Para el resto de criterios véase el protocolo criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the study is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16
    El criterio de valoración principal del estudio es el cambio porcentual en la puntuación del Eczema Area and Severity Index (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)
    The Efficacy secondary endpoints are:
    • 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 scores from baseline to week 16
    • Proportion of patients with both an 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)
    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) Pharmacokinetic (PK):
    •Concentrations of functional REGN3500 in serum by treatment regimen at each assessment time point from baseline to end of study (week 36)
    Los criterios secundarios de eficacia son:
    - 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 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 acontecimientos adversos emergentes en el tratamiento (treatment-emergent adverse events, TEAE) desde el basal al fin del tratamiento (semana 16)
    •Incidencia de acontecimientos adversos graves (serious adverse events, SAE) emergentes en el tratamiento desde el basal al fin del tratamiento (semana 16)
    •Incidencia de acontecimientos adversos de especial interés emergentes en el tratamiento (treatment-emergent adverse events of special interest, AESI) desde el basal al fin del tratamiento (semana 16)
    •Incidencia de TEAE desde el basal al fin del estudio (semana 36)
    •Incidencia de SAE emergentes en el tratamiento desde el basal al fin del estudio (semana 36)
    •Incidencia de AESI desde el basal al fin del estudio (semana 36)
    Farmacocinética (PK):
    •Concentraciones séricas de REGN3500 funcional por régimen de tratamiento en cada momento de evaluación, desde el basal al fin del estudio (semana 36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 and Week 36
    Semana 16 y Semana 36
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Canada
    Czech Republic
    France
    Germany
    Japan
    Korea, Republic of
    Poland
    Spain
    United Kingdom
    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 final del estudio se define como la fecha en que el último paciente completa su 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 months5
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 270
    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 129
    F.4.2.2In the whole clinical trial 300
    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
    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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