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    Summary
    EudraCT Number:2016-000488-17
    Sponsor's Protocol Code Number:LUPIL-2
    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:2016-11-18
    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 number2016-000488-17
    A.3Full title of the trial
    A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)
    Estudio multicentrico en fase II, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, la seguridad y la farmacocinetica de ILT-101 en pacientes con lupus eritematoso sistemico (LES) activo moderado a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)
    Un estudio para evaluar la efectividad y la seguridad del farmaco del estudio, cuando se administra ILT 101 a pacientes con lupus eritematoso sistemico (LES) activo moderado a grave.
    A.4.1Sponsor's protocol code numberLUPIL-2
    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 SponsorILTOO PHARMA
    B.1.3.4CountryFrance
    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 supportILTOO PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationILTOO PHARMA
    B.5.2Functional name of contact pointJérémie MARIAU
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Pitié-Salpêtrière 47/83, Bd de l'Hôpital
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number33157274561
    B.5.6E-mailj.mariau@iltoopharma.fr
    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 nameILT-101
    D.3.2Product code ILT-101
    D.3.4Pharmaceutical form Powder 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 INNAldesleukin
    D.3.9.1CAS number 110942-02-4
    D.3.9.3Other descriptive nameINTERLEUKIN-2
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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 placeboPowder 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
    Systematic Lupus Erythematosus
    lupus eritematoso sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systematic Lupus Erythematosus(SLE) is an automimmune disease in which the body's immune system mistakenly attacks healthy tissue.
    Lupus Eritematoso Sistémico (LES) es una enfermedad autoimmune en la que el Sistema inmune del cuerpo ataca por error a los órganos sanos
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 the evaluation of the clinical efficacy of ILT-101 (1.5 MUI of IL-2 daily for 5 days and then weekly from day 8 to day 162) at week 12 in active SLE patients with moderate to severe disease activity.
    El objetivo primario del estudio es la evaluación de la eficacia clínica de ILT-101 (1.5 MUI de Il-2 diariamente durante 5 días y después semanalmente desde el dia 8 al dia 162) en la semana 12 en pacientes LES activo con actividad de la enfermedad de moderada a severa.
    E.2.2Secondary objectives of the trial
    To assess:
    1/ Maintenance of clinical efficacy (at week 24) within responders (i.e.
    those with SRI-4 at week 12)
    2/ Maintenance of clinical efficacy at week 36 within responders
    3/ Safety of ILT-101 during the treatment period
    4/ Relationship between immunological cell subsets (Tregs) and clinical
    endpoints
    Evaluar:
    1. El mantenimiento de la eficacia clínica en la semana 24 de los pacientes con respuesta (es decir, SRI-4 en la semana 12)
    2. El mantenimiento de la eficacia en la semana 36 en los pacientes que responden a tratamiento
    3. Seguridad de ILT-101 durante el periodo de tratamiento
    4. Relación entre los subgrupos de células inmunitarias (Tregs) y los criterios de valoración clínicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -- Age ≥ 18 years
    - Male or female
    - Having a confirmed diagnosis of SLE assessed by the presence of at least 4 of the criteria of American College of Rheumatology (ACR) list or of the Systemic Lupus International Collaborating Clinics (SLICC) list at least at diagnosis.
    - Having an active SLE characterised by:
    > SELENA-SLEDAI score ≥ 6
    > Positive for Anti-nuclear antibody (ANA), titre (≥1:80)
    > Positive for anti-dsDNA antibody
    > Low levels (below the laboratory normal range) of C3 or C4 complement components OR a SELENA-SLEDAI score ≥ 8
    - Being on stable background therapy (dose and type) before inclusion including any corticotherapy at dose ≥7.5mg/day but lower than 30mg/day or 0.5mg/kg/day whichever is the lower. Corticosteroids and antimalarial drug should be stable for 1 month prior to inclusion, immunosuppressant must be stable for 2 months prior to inclusion.
    - Using highly effective methods of contraception during the duration of the study, including oral, or injectable hormonal contraceptives or intrauterine device or systems, vasectomised partner, bilateral tubal occlusion, combined with condom
    - Having freely provided informed consent to participate in the study preceding any study procedure
    - Edad ≥ 18 años o mayores
    - Hombres y mujeres
    -Teniendo un diagnostico confirmado de LES evaluado por la presencia de al menos 4 de los criterios del Colegio Norteamericano de Reumatología (ACR) o de las Clínicas internacionales que mantienen una colaboración en el campo del lupus sistémico (SLICC), al menos durante el diagnóstico.
    - Con lupus activo caracterizado por:
    • Puntuación de SELENA-SLEDAI ≥ 6
    • Presencia de anticuerpos antinucleares (ANA), con un título ≥1:80
    • Presencia de anticuerpos anti-ADNbc
    • Con bajos niveles (por debajo del intervalo normal del laboratorio) de fracciones de complemento C3 o C4 O una puntuación de SELENA-SLEDAI ≥ 8
    - Tratamiento de referencia estable (dosis y tipo) antes de la inclusión en el estudio, incluido el tratamiento con corticoesteroides a una dosis de ≥7,5mg/día pero inferior a 30mg/day o 0.5mg/kg/day lo que resulte mas bajo. Corticoides y antimalaricos deben ser estables por un periodo de un mes antes de la inclusión, los inmunodepresores deben ser estables durante los 2 meses anteriores a la inclusión.
    - Los hombres y mujeres sexualmente activos deben utilizar métodos anticonceptivos eficaces durante el tratamiento, entre los que se incluyen anticonceptivos hormonales orales, inyectables o sistemas o dispositivos intrauterinos, vasectomía, oclusión tubular bilateral o abstinencia sexual
    - Haber firmado de forma voluntaria el consentimiento informado para participar en el estudio antes de empezar con los procedimientos del estudio
    E.4Principal exclusion criteria
    - A known contraindication to treatment with IL-2:
    > Hypersensitivity to the active substance or to any of its excipients
    > Ongoing infection (requiring antibiotic treatment or fever≥38°C) at the time of inclusion
    > Blood oxygen saturation ≤ 90% in resting position
    > A previous organ allograft
    - Serious organ failure:
    > Renal functional impairment (glomerular Filtration Rate <60ml/min) OR (urinary protein ≥ 2g/24h with normal albuminemia)
    > Severe central nervous system manifestations
    > Heart failure of grade 3 or greater by the NYHA classification
    > Liver failure with transaminases more than 5 times the upper limit of normal
    - Any clinical evidence of active chronic infection, HIV infection (positive serum antibodies against HIV1/2), active or chronic hepatitis B infection (positive for HBs-Ag in serum), active or chronic
    hepatitis C infection (positive for serum antibodies against HCV).
    - Patient with clinical significant pleuritis with pleural effusion and/or pericarditis
    - Patient diagnosed with type 1 diabetes and/or Crohn’s disease
    - Use of Benlysta (belimumab) in the past 4 weeks
    - Use of or Rituximab in the past 24 weeks (6 months) prior to inclusion
    - Use of cyclosporine, interferon alpha and antimitotic agents in the past 4 weeks
    - Use of any prohibited drug prior to the study participation as described in section 9.3 and 9.4
    - Vaccination with live attenuated virus in the last month
    - Necessity for application of radiographic iodinated contrast media during and 2 weeks after the completion of the treatment
    - A white blood cell count <2000/ mm 3, platelets <50 000/ mm 3 or Anemia with Hb≤0.8 g/dl
    - Elevated TSH and T4
    - Existing cancer or a history of cancer treated within the past five years, except cervical carcinoma in situ or basal cell carcinoma
    - Veins in a poor state unsuitable for venepuncture
    - Major surgery in the previous two months or anticipated during the course of the Study period
    - In women, pregnancy or lactation
    - Psychiatric pathology or any other chronic illness or addiction that might interfere with the ability to provide informed consent or to comply with the requirements of the Protocol
    - A patient under legal protection
    - Having received any investigational product (small molecule or biologic) or commercially available biologic agent within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater
    - Contraindicación conocida al tratamiento con IL-2
    • Hipersensibilidad al principio activo o a alguno de los excipientes
    • Infección en curso (que requiera tratamiento antibiótico o fiebre > 38°C) en el momento de la inclusión
    • Saturación de oxígeno en sangre ≤ 90% en posición de descanso
    • Aloinjerto previo
    - Insuficiencia orgánica grave
    • Insuficiencia renal (filtración glomerular < 60ml/min o proteinuria ≥ 2g/24h con albuminemia normal
    • Afectaciones graves en el sistema nervioso central
    • Insuficiencia cardíaca de grado 3 o mayor según la clasificación de la NYHA
    • Insuficiencia hepática con transaminasas superiores a 5 veces el límite superior de normalidad
    - Cualquier evidencia clínica de infección activa crónica, infección por VIH (anticuerpos del suero positivo VHI ½) Hepatitis B activa o crónica (HBs-Ag positivo en suero) activo o crónico para Hepatitis C (Anticuerpos positivos en suero frente a HCV)
    Pacientes con evidencia clínica de pleuritis con efusión pleural y o pericarditis
    Pacientes diagnosticados de diabetes tipo 1 o enfermedad de Crohn
    - Uso de Benlysta (belimumab) en los últimos 4 semanas
    - Uso de Rituximab en los últimos 24 semanas (6 meses) antes de la inclusion
    - Uso de ciclosporina, interferón alfa y antimitóticos en los últimos 4 semanas
    Uso de la medicación prohibida previo a la participación en el estudio como se describe en la sección 9.3 y 9.4
    Administración de una vacuna de microorganismos vivos atenuados en el último mes
    Necesidad de aplicación de radiografia ionica de contraste durante los 2 semanas posteriores a completar el tratamiento
    - Recuento de leucocitos <2000/mm3, plaquetas <50 000/mm3 o anemia Hb≤0.8g/dl
    -TSH y T4 elevadas
    - - Existencia o antecedentes de neoplasias malignas tratadas en los últimos 5 años y en remisión, excepto el carcinoma in situ o basal de cuello uterino
    - Sistema venoso muy deteriorado no apto para la venopunción
    - Cirugía en los dos meses previos o programada durante el curso del periodo del estudio
    - Mujeres embarazadas o en periodo de lactancia
    - Trastornos psiquiátricos u otras enfermedades crónicas o adicciones que puedan interferir en la capacidad de otorgar el consentimiento informado o de cumplir con los requisitos del protocolo
    - Paciente bajo protección judicial
    - Haber recibido otro producto en fase de investigación (molécula pequeña o agente biológico) o agente biológico disponible comercialmente durante cuatro semanas o 5 semividas antes de firmar el FCI (el periodo que sea superior)
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with a SLE responder index of 4 (SRI-4) at week 12, SRI-4 response being defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score as compared to baseline, and (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points
    El porcentaje de pacientes con un índice de respuesta a LES de 4 (SRI-4) en la semana 12, respuesta SRI´4 se define como (1) reducción ≥ a 4 puntos en la puntuación de la escala SELENA-SLEDAI en comparación con basal, y (2) sin nueva puntuación BILAG A o nueva puntuación BILAG B ≤ 1, y (3) sin deterioro desde basal en la evaluación física global por ≥ 0.3 puntos
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after baseline
    12 semanas después de basal
    E.5.2Secondary end point(s)
    Maintenance of clinical response
    - Number and percentage of W12 SRI-4 responder patients who sustain SRI-4 response at week 24
    - Percentage of W12 SRI-4 responder patients with mild/moderate or severe flares according to SFI at week 24

    Corticosteroids tapering
    • Prednisone-equivalent CS daily dose at week 12 as compared with baseline, at week 24 compared with week 12 and at week 36 as compared with week 24
    - Percentage of patients able to reduce oral steroid dose to 15mg daily at week 12, and to 7.5 mg daily prednisone at week 24
    - Percentage of patients able to reduce oral steroid dose by 25 and 50% at week 12, 16, 20 and 24 as compared to baseline

    Biological response
    - Change in anti-dsDNA at week 4, 8, 12, 20, 24 and 36 as compared to baseline
    - Change in blood Tregs (expressed as percentage of CD4 and absolute numbers) at day 5, week 4, 12, 24 and 36 as compared to baseline

    Safety
    - Safety parameters assessed by clinical examination, routine laboratory tests, recording of adverse events and vital signs preceding any study procedure

    Maintenance of clinical response from week 12 to 24
    Number and percentage of W12 SRI-4 responder patients who sustain SRI-4 response at week 16 and 20
    - Number and percentage of W12 SRI-4 responder patients with mild/moderate or severe flares according to SFI at week 16 and 20
    - Time to flare between week 12 and week 24 in W12 SRI-4 responder patients
    - Percentage of patients having a SRI-4 response at week 4, 8 or 12 and who sustain it for 3 months
    - Percentage of W12 SRI-4 responder patients fulfilling SRI-6, SRI-8, BICLA criteria at week 16, 20 and 24 as compared to baseline
    Maintenance of biological and clinical response at week 36
    • Number and percentage of W12 and W24 SRI-4 responder patients who sustain SRI-4 response at week 36
    • Number and percentage of W12 and W24 SRI-4 responder patients with mild/moderate or severe flares according to SFI at week 36
    • Time to flare between week 24 and week 36 in W24 SRI-4 responder patients
    • Percentage of W12 and W24 SRI-4 responder patients fulfilling SRI-6, SRI-8, BICLA criteria at week 36 as compared to week 24
    • Change in anti-dsDNA at week 36 as compared to week 24
    • Change in blood Tregs (expressed as percentage of CD4 and absolute numbers) at week 36 as compared to week 24

    Early clinical response
    - Number and percentage of patients responding to treatment according to SRI-4 at week 4 and 8 as compared to baseline
    - Number and percentage of patients fulfilling SRI-6, SRI-8, BICLA criteria at week 4, 8 and 12 as compared to baseline
    - Time to first SRI-4, -6, -8 response during the first three months
    - Time to flare during the first three months
    - Number and percentage of patients with mild/moderate or severe flares according to SFI at week 4, 8 and 12

    Other clinical assessments
    - Absolute and relative change in SELENA-SLEDAI at week 4, 8, 12, 16, 20 24 and 36 as compared to baseline
    - Absolute and relative change in BILAG at week 4, 8, 12, 16, 20, 24 and 36 as compared to baseline
    - Absolute and relative change in PGA at week 4, 8, 12, 16, 20, 24 and 36 as compared to baseline
    - Percentage of patients in remission (SLEDAI≤2) at week 4, 8, 12, 16, 20, 24 and 36
    - Quality of life index: Lupus QoL at week 4, 12, 24 and 36 as compared to baseline
    - Fatigue by VAS and fatigue severity scale at week 4, 8, 12, 24 and 36 as compared to baseline
    Biological response
    - Change in C3/C4 at week 4, 8, 12, 20, 24 and 36 as compared to baseline
    - Quantification of anti-ILT-101 antibodies and of their neutralising effect at baseline, week 12 and 24
    Mantenimiento de la respuesta clínica:
    -Número y porcentaje de pacientes respondedores semana 12 SRI-4 los cuales mantienen respuesta SRI-4 en la semana 24
    -porcentaje de pacientes respondedores s12 SRI-4 con brotes medio/moderado a severo en relación a SFI en semana 24

    Reducción de cobticosteroides
    -Prednisona-equivalente CS a dosis diaria en semana 12 en comparación con basal, en semana 12 comparado con semana 12 y en semana 32 en comparación con semana 24
    -Porcentaje de pacientes capaces de reducir la dosis de esteroides orales a 15 mg diarios en semana 12 y a 7.5 mg de prednisona diaria en semana 24
    -Porcentaje de pacientes capaces de reducir la dosis de esteroides orales entre 25 y 50% en semanas 12,16,20 y 24 en comparación con basal

    Respuesta biológica:
    -Cambio en anti-dsDNA en semanas 4,8,12,20, 24 y 36 en comparación con basal
    -Cambio en sangre Tregs (expresado como porcentaje de CD4 y números absolutos) en el día 5, semanas 4,12,24 y 36 en comparación con basal

    Seguridad
    -Parámetros de seguridad evaluados por examen clínicco, test de laboratorios rutinarios, registro de efectos adversos y signos vitales que preceden a los procedimientos del estudio.

    Mantenimiento de la respuesta clínica de las semanas 12 a 24
    Número y porcentaje de pacientes respondedores s12 SRI-4 los cuales sostienen la respuesta SRI-4 en semana 16 y 20
    -Numero y porcentaje de pacientes respondedores s12 SRI-4 con brotes medio/moderado a severo en relación a SFI en semana 16 y 20
    -Tiempo de brotar entre semana 12 y semana 24 en pacientes respondedores s12 SRI-4
    -Porcentaje de pacientes que tienen respuesta SRI-4 en semanas 4,8 o 12 y que lo mantienen durante 3 meses
    -Porcentaje de pacientes respondedores S12 Ssri-4, cumpliendo SRI-6, SRI-8, BICLA en semana 16,20 y 24 en comparación con basal
    Mantenimiento de respuesta biológica y clínica en semana 36
    -Número y porcentaje de pacientes respondedores s12 y S24 SRI-4 los cuales sostienen la respuesta SRI-4 en semana 36
    -Numero y porcentaje de pacientes respondedores S12 y S24 SRI-4 con brotes medio/moderado a severo en relación a SFI en semana 36
    -Tiempo de brotar entre semana 24 y semana 36 en pacientes respondedores S24 SRI-4
    -Porcentaje de pacientes respondedores S12 y S24 SRI-4, cumpliendo SRI-6, SRI-8, BICLA en semana 36 en comparación con semana 24
    -Cambio en anti-dsDNA en semana 36 en comparación con semana 24
    -Cambio en sangre Tregs (expresado como porcentaje de CD4 y números absolutos) en semana 36 en comparación con semana 24

    Respuesta clínica temprana
    -Número y porcentaje de pacientes que responden al tratamiento de acuerdo a SRI-4 en semana 4 y 8 en comparación con basal
    -Número y porcentaje de pacientes cumpliendo SRI-6, SRI-8, criterio BICLA en semanas 4,8 y 12 en comparación con basal
    -Tiempo a la primera respuesta SRI-4,-6,-8 durante los primeros 3 meses
    -Tiempo de brote durante los tres primeros meses
    -Numero y porcentaje de con brotes medio/moderado o severo en relación a SFI en semana 4,8 y 12

    Otras evaluaciones clínicas:
    -Cambio absoluto y relativo en SELENA-SLEDAI en semana 4, 8, 12,16,20 24 y 36 en comparación con basal
    -Cambio absoluto y relativo en BILAG en semana 4, 8, 12,16,20 24 y 36 en comparación con basal
    -Cambio absoluto y relativo en PGA en semana 4, 8, 12,16,20 24 y 36 en comparación con basal
    -Porcentaje de pacientes en remisión (SLEDAI≤2) en semana 4, 8, 12.16,20 24 y 36
    -Calidad del índice de vida: QoL de lupus en semana 4,12,24 y 36 en comparación con basal
    -Fatiga por VAS y escala de la severidad de la fatiga en semana 4, 8, 12,20 24 y 36
    Respuesta biológica
    -Cambio en C3/C4 en semana 4, 8, 12,20 24 y 36
    -Calificación de anticuerpos anti ILT-101y de sus efectos neutralizantes en basal, semana 12 y 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2
    Por favor diríjase a E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Mexico
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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)
    There is currently no plan for after care
    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 Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
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