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    Summary
    EudraCT Number:2017-004574-34
    Sponsor's Protocol Code Number:I4V-MC-JAIN
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-27
    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 number2017-004574-34
    A.3Full title of the trial
    A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination with Topical Corticosteroids in Adult Patients with Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine
    Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y comparado con placebo, para evaluar la seguridad y la eficacia de baricitinib en combinación con corticosteroides tópicos en pacientes adultos con dermatitis atópica de moderada a grave que no hayan respondido, presenten intolerancia o contraindicación al tratamiento con ciclosporina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine A or for Those Who Cannot Take Oral Cyclosporine A Because it is Not Medically Advisable
    Estudio a largo plazo de baricitinib (LY3009104) con corticosteroides tópicos en adultos con dermatitis atópica moderada o grave no controlada con ciclosporina A o en aquellos que no pueden tomar este medicamento por vía oral por recomendación médica
    A.3.2Name or abbreviated title of the trial where available
    BREEZE-AD4
    BREEZE-AD4
    A.4.1Sponsor's protocol code numberI4V-MC-JAIN
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointPaula Anabella Fotti
    B.5.3 Address:
    B.5.3.1Street AddressAv de la Industria 30
    B.5.3.2Town/ cityAlcobendas/ Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916635039
    B.5.6E-mailensayosclinicos@lilly.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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    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 also known as Eczema
    Dermatitis atópica (también denominada "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 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
    To test the hypothesis that baricitinib 4 mg + topical corticosteroids (TCS) or baricitinib 2 mg + TCS is superior to placebo + TCS in the treatment of moderate to severe atopic dermatitis
    Evaluar la hipótesis de que baricitinib 4 mg + corticosteroides tópicos (CT) o baricitinib 2 mg + CT es superior al placebo + CT en el tratamiento de la dermatitis atópica moderada o grave.
    E.2.2Secondary objectives of the trial
    • To test the hypothesis that baricitinib 1 mg + topical corticosteroids (TCS) is superior to placebo + TCS in the treatment of patients with moderate to severe atopic dermatitis.
    • To compare the efficacy of baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, or baricitinib 1 mg + TCS to placebo + TCS in atopic dermatitis during the double blind placebo controlled treatment period as measured by improvement of signs and symptoms of atopic dermatitis.
    • To compare the efficacy of baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, or baricitinib 1 mg + TCS to placebo + TCS in atopic dermatitis during the double blind placebo controlled treatment period as assessed by patient reported outcome measures.
    • Evaluar la hipótesis de que baricitinib 1 mg + corticosteroides tópicos (CT) es superior al placebo + CT en el tratamiento de pacientes con dermatitis atópica moderada o grave.
    • Comparar la eficacia de baricitinib 4 mg + CT, baricitinib 2 mg + CT o baricitinib 1 mg + CT con la del placebo + CT en la dermatitis atópica durante el período de tratamiento con enmascaramiento doble y comparativo con placebo de acuerdo con la mejoría de los signos y los síntomas de la dermatitis atópica.
    • Comparar la eficacia de baricitinib 4 mg + CT, baricitinib 2 mg + CT o baricitinib 1 mg + CT con la del placebo + CT en la dermatitis atópica durante el período de tratamiento con enmascaramiento doble y comparativo con placebo de acuerdo con los resultados percibidos por el paciente
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Randomized DownTitration Substudy at week 52
    During the long term extension (Period 3), eligible patients will participate in a downtitration substudy. The objective of the substudy is to evaluate the possibility of maintaining efficacy with a lower dose of baricitinib in patients with response (IGA 0 or 1) or partial response (IGA 2) to baricitinib 2-mg QD or 4-mg QD in combination with topical corticosteroids.
    Subestudio de disminución gradual y aleatorizada de la dosis en la semana 52. Durante la prolongación a largo plazo (período 3), los pacientes idóneos
    participarán en un subestudio de disminución gradual de la dosis. El objetivo del subestudio es evaluar la posibilidad de mantener la eficacia con una dosis inferior de baricitinib en pacientes que presenten respuesta (puntuación de 0 o 1 de acuerdo con la EGI) o respuesta parcial (puntuación de 2 de acuerdo con la EGI) al tratamiento con baricitinib 2 mg o 4 mg una vez al día, en combinación con corticosteroides tópicos.
    E.3Principal inclusion criteria
    • Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for at least 12 months.
    • Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
    • Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period and throughout the study).
    • Agree to use emollients daily.
    • Have a medical contraindication to cyclosporine A, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine A in the past.
    • Diagnóstico de eccema atópico (dermatitis atópica) moderado o grave al menos desde hace 12 meses.
    • Haber presentado respuesta insuficiente o intolerancia a los tratamientos tópicos existentes (de aplicación cutánea) en el transcurso de los 6 meses anteriores a la selección.
    • Estar dispuesto a interrumpir ciertos tratamientos para el eccema (como los tratamientos tópicos y sistémicos, tanto durante el período de reposo farmacológico como durante el estudio).
    • Estar dispuesto a usar emolientes todos los días.
    • Presentar una contraindicación médica a la administración de ciclosporina A, o haber mostrado anteriormente intolerancia, toxicidad inaceptable o respuesta insuficiente a la ciclosporina A.
    E.4Principal exclusion criteria
    • Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
    • A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
    • Participants who are currently experiencing a skin infection that requires treatment, or are currently being treated, with topical or systemic antibiotics.
    • Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
    • Have been treated with the following therapies:
    - Monoclonal antibody for less than 5 half-lives prior to randomization.
    - Received prior treatment with any oral Janus kinase (JAK) inhibitor.
    - Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
    - Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
    • Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
    • Have had major surgery within the past eight weeks or are planning major surgery during the study.
    • Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
    • Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
    • Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
    • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
    • Have specific laboratory abnormalities.
    • Have received certain treatments that are contraindicated.
    • Pregnant or breastfeeding.
    • Sufrir en la actualidad o haber sufrido otras enfermedades cutáneas (por ejemplo, psoriasis o lupus eritematoso), o antecedentes de una enfermedad cutánea eritrodérmica, resistente al tratamiento o inestable que requiera la hospitalización o tratamiento intravenoso para las infecciones cutáneas con frecuencia.
    • Antecedentes de eccema herpético en el transcurso de los 12 últimos meses, o de 2 o más episodios anteriores de eccema herpético.
    • Presentar en la actualidad una infección cutánea que requiera tratamiento o recibir en la actualidad antibióticos sistémicos o tópicos.
    • Presentar cualquier enfermedad grave para la que se prevea el uso de corticosteroides sistémicos, que afecte la participación en el estudio o requiera seguimiento activo y frecuente (por ejemplo, asma crónica inestable).
    • Haber recibido los tratamientos siguientes:
    -Anticuerpos monoclonales antes de la aleatorización (período inferior a
    5 semividas del fármaco).
    -Haber recibido tratamiento previo con cualquier inhibidor oral de las
    janocinasas (JAK).
    -Pacientes que hayan recibido corticosteroides, administrados por vía parenteral (mediante inyección intramuscular o intravenosa [IV]), en el transcurso de las 2 semanas previas a la inclusión en el estudio o de las 6 semanas previas a la fecha prevista de aleatorización, o que se prevea
    que vayan a requerir inyecciones parenterales de corticosteroids durante el estudio.
    -Haber ecibido corticosteroides por vía intrarticular en el transcurso de las 2 semanas previas a la inclusión en el estudio o de las 6 semanas
    previas a la fecha prevista de aleatorización.
    • Presentar hipertensión arterial (tensión arterial sistólica > 160 milímetros de mercurio [mm Hg] o tensión arterial diastólica > 100 mm Hg de forma repetida).
    • Haberse sometido a una intervención de cirugía mayor en el transcurso de las últimas 8 semanas o tener prevista una intervención de cirugía
    mayor durante el estudio.
    • Haber experimentado alguna de las siguientes enfermedades en el transcurso de las 12 semanas anteriores a la selección: episodio
    tromboembólico venoso (ETV), infarto de miocardio (IM), cardiopatía isquémica inestable, accidente cerebrovascular o insuficiencia cardiaca
    de clase III/IV de acuerdo con los criterios de la New York Heart Association.
    • Antecedentes de ETV recurrentes (≥ 2) o riesgo alto de ETV según el criterio del investigador.
    • Antecedentes o presencia de enfermedades cardiovasculares, respiratorias, hepáticas, gastrointestinales, endocrinas, hematológicas,
    neurológicas, linfoproliferativas, neuropsiquiátricas, o hepatopatías crónicas o cualquier otra enfermedad grave o inestable.
    • Presentar o haber presentado recientemente una infección grave desde un punto de vista clínico (vírica, bacteriana, fúngica o parasitaria),
    incluidos el herpes zóster o la tuberculosis.
    • Presentar determinadas alteraciones analíticas.
    • Haber recibido ciertos tratamientos contraindicados.
    • Pacientes embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥ 2 point improvement
    Porcentaje de pacientes que alcancen una puntuación de 0 o 1 en la evaluación global del investigador (EGI), con una mejoría de ≥ 2 puntos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    1,
    • Proportion of patients achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥ 2 point improvement
    • Proportion of patients achieving EASI75
    • Proportion of patients achieving EASI 90
    • Mean change from baseline in EASI score
    • Proportion of patients achieving SCORAD75
    • Mean change from baseline in Skin Pain NRS

    2;
    • Proportion of patients achieving a 4-point improvement in Itch NRS
    3;
    • Mean change from baseline in the score of Item 2 of the ADSS
    4;
    • Proportion of patients achieving IGA of 0 or 1 with a ≥2-point improvement from baseline
    • Proportion of patients achieving EASI75
    1;
    • Porcentaje de pacientes que alcancen una puntuación de 0 o 1 en la
    evaluación global del investigador (EGI), con una mejoría de ≥ 2 puntos.
    • Porcentaje de pacientes que alcancen una respuesta EASI 75.
    • Porcentaje de pacientes que alcancen una respuesta EASI 90.
    • Media de la variación en la puntuación EASI respecto al período basal.
    • Porcentaje de pacientes que alcancen una respuesta SCORAD75.
    • Media de la variación respecto al período basal en la EVN del dolor
    cutáneo.
    2;
    • Porcentaje de pacientes que alcancen una mejoría de 4 puntos en la EVN del picor;
    3
    • Media de la variación respecto al período basal en la puntuación del ítem 2 de la escala ADSS
    4;
    • Porcentaje de pacientes que presenten una puntuación de 0 o 1 en la EGI, con una mejoría de ≥ 2 puntos respecto al período basal.
    • Porcentaje de pacientes que alcancen una respuesta EASI 75.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1; assessed at week 16
    2; assessed at 16, 4, 2, and 1 weeks
    3; assessed at 16 weeks and 1 week.
    4; assessed at 52 weeks
    1; se evalúa en la semana 16.
    2; se evalúa en las semanas 16, 4, 2 y 1.
    3; se evalúa en las semanas 16 y 1.
    4; se evalúa en la semana 52.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker research
    Investigación de biomarcadores
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Austria
    Belgium
    Brazil
    Finland
    France
    Germany
    Italy
    Japan
    Netherlands
    Poland
    Russian Federation
    Spain
    Switzerland
    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
    End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient.
    El final del ensayo es la fecha de la última visita o del último procedimiento programado para el último paciente del estudio según se detalla en el calendario de actividades.
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 475
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 357
    F.4.2.2In the whole clinical trial 500
    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 Decision2018-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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