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    Summary
    EudraCT Number:2017-001944-36
    Sponsor's Protocol Code Number:20170149
    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:2017-10-10
    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 number2017-001944-36
    A.3Full title of the trial
    A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy
    Estudio de fase 1b/2a para evaluar la seguridad y la eficacia de
    AMG 592 en sujetos con artritis reumatoide activa que responden de manera insuficiente al tratamiento estándar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis
    Seguridad y la eficacia de AMG 592 en sujetos con artritis reumatoide activa
    A.4.1Sponsor's protocol code number20170149
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34900850153
    B.5.6E-mailMedinfoInternational@amgen.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 nameAMG592
    D.3.4Pharmaceutical form 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 INNAMG 592
    D.3.9.2Current sponsor codeAMG 592
    D.3.9.3Other descriptive nameRECOMBINANT FACTOR FC FUSION PROTEIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 placeboSolution 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
    Rheumatoid Arthritis
    artritis reumatoide (AR)
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    artritis reumatoide
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b
    • To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of AMG 592 in subjects with active RA
    Phase 2a
    • To evaluate the efficacy of AMG 592 at week 12 as measured by the American
    College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA
    Fase 1b
    -Evaluar la seguridad y la tolerabilidad de
    las administraciones de dosis por vía
    subcutánea (SC) de AMG 592 en sujetos
    con AR activa.
    Fase 2a
    -Evaluar la eficacia de AMG 592 en la
    semana 12, determinada según los criterios
    de mejoría del 20% del American College
    of Rheumatology (ACR 20) en sujetos
    adultos con AR moderada o grave.
    E.2.2Secondary objectives of the trial
    Phase 1b
    • To characterize the pharmacokinetic (PK) profile following treatment with AMG 592
    • To evaluate the incidence of anti-AMG 592 antibody formation and cross-reactivity to human IL-2.
    Phase 2a
    • To evaluate the effect of treatment with AMG 592 on other measures of disease
    • To evaluate the safety of AMG 592
    • To characterize the PK of AMG 592 in subjects with RA activity at week 12
    Fase 1b
    -Describir la farmacocinética (el perfil PK
    después del tratamiento con AMG 592).
    -Evaluar la incidencia de la formación de
    anticuerpos anti-AMG 592 y la reactividad
    cruzada al IL-2 humano.
    Fase 2a
    -Evaluar el efecto del tratamiento con
    AMG 592 en otras mediciones de la
    actividad de la enfermedad en la
    semana 12.
    -Evaluar la seguridad de AMG 592.
    -Describir la PK de AMG 592 en sujetos
    con AR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study specific
    activities/procedures.
    - Age ≥ 18 to ≤ 70 years of age at screening
    - A diagnosis of RA consistent with the 1987 or 2010 American College of
    Rheumatology (ACR)/European League Against Rheumatism classification
    criteria
    - Active RA defined as:
    • Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of
    the finger joints excluding the distal interphalangeal joints, the wrists, elbows,
    shoulders, and knees.
    • Phase 2a: ≥ 6 swollen joints (based on 66-joint count) and ≥ 6 tender joints
    (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.
    - Receiving treatment with methotrexate for ≥ 12 weeks and on a stable dose
    ≥ 15 mg weekly for ≥ 8 weeks prior to day 1. A lower methotrexate dose is
    acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose
    and gastrointestinal or hematologic toxicity at doses ≥ 15 mg weekly is
    documented by the investigator.
    - Receiving treatment with folic or folinic acid per investigator judgment or
    according to local standard of care.
    - Phase 1b only: Subject may be receiving a stable dose of leflunomide,
    sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for ≥ 8 weeks prior to day 1.
    - Subject may be receiving a stable dose of prednisone ≤ 10mg daily or other
    equivalent corticosteroid dose and the dose must be stable for ≥ 2 weeks prior to
    day 1.
    - Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting
    ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline
    based on opinion of the investigator.
    - Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu
    season], and pneumococcal [polysaccharide] vaccinations) up to date per local
    standards as determined by the investigator.
    -El sujeto ha proporcionado su consentimiento informado antes de iniciar cualquier procedimiento/actividad específicos del estudio.
    -≥ 18 a ≤ 70 años de edad en la selección.
    -Un diagnóstico de AR coherente con los criterios de clasificación de 1987 o 2010 del American College of Rheumatology (ACR)/la European League Against Rheumatism.
    -AR activa definida como:
    Fase 1b: DAS-28-CRP > 2,6 en la selección. El recuento de 28 articulaciones incluye las articulaciones de los dedos y no incluye las articulaciones interfalángicas distales, las muñecas, los codos, los hombros ni las rodillas.
    Fase 2a: ≥ 6 articulaciones inflamadas (según un recuento de 66 articulaciones) y ≥ 6 articulaciones dolorosas (según un recuento de 68 articulaciones) en la selección y la situación basal. Aunque no debe incluirse, la articulación interfalángica distal debe evaluarse en el recuento total para determinar la elegibilidad. Además, la proteína C reactiva (PCR) debe ser mayor que el límite superior de la normalidad (LSN), según las determinaciones del laboratorio central durante la selección.
    -Estar recibiendo tratamiento con metotrexato durante ≥ 12 semanas y con una dosis estable de ≥ 15 mg a la semana durante ≥ 8 semanas antes del día 1. Se puede permitir una dosis más baja de metotrexato (que no sea inferior a 10 mg a la semana) cuando sea la dosis máxima tolerada y el investigador haya documento toxicidad gastrointestinal o hematológica con dosis de ≥ 15 mg a la semana.
    -Estar recibiendo tratamiento con ácido fólico o folínico, según el criterio del investigador o de acuerdo con el tratamiento estándar local.
    -Solo para la fase 1b: el sujeto puede estar recibiendo una dosis estable de leflunomida sulfasalazina, hidroxicloroquina y minociclina en combinación con metotrexato y la dosis debe mantenerse estable durante ≥ 8 semanas antes del día 1.
    -El sujeto puede estar recibiendo una dosis estable de ≤ 10 mg de prednisona al día u otra dosis de corticosteroides equivalentes y la dosis debe mantenerse estable durante ≥ 2 semanas antes del día 1.
    -Solo para la fase 1b: valores del ECG normales o clínicamente aceptables (12 derivaciones que registran la frecuencia ventricular y los intervalos PR, QRS, QT y QTc) en la selección y la situación basal, según el criterio del investigador.
    -Vacunaciones (vacunas de tétanos, difteria, tosferina, gripe estacional [durante la temporada de gripe] y neumococos [polisacáridos]) actualizadas según los estándares locales determinados por el investigador.
    E.4Principal exclusion criteria
    Disease Related:
    - Class IV RA according to ACR revised response criteria
    - Diagnosis of Felty’s Syndrome (RA, splenomegaly and granulocytopenia)
    Other Medical Conditions
    - Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.
    - Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.
    - Known history of active tuberculosis
    - Positive test for tuberculosis during screening
    - Positive for hepatitis B surface antigen, hepatitis B core antibody .
    - Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or
    known to be HIV positive. Phase 2a only: Known history of HIV
    - Positive drug or alcohol urine test at screening.
    - Presence of one or more significant concurrent medical conditions per
    investigator judgment, including but not limited to the following:
    • poorly controlled diabetes or hypertension
    • chronic kidney disease stage IIIb, IV, or V
    • symptomatic heart failure (New York Heart Association class II, III, or IV)
    • myocardial infarction or unstable angina pectoris within the past
    12 months prior to randomization
    • severe chronic pulmonary disease (eg, requiring oxygen therapy)
    • multiple sclerosis or any other demyelinating disease
    • major chronic inflammatory disease or connective tissue disease other
    than RA
    - Malignancy except non-melanoma skin cancers, cervical or breast ductal
    carcinoma in situ within the last 5 years.
    - History of alcohol or substance abuse within 6 months of screening
    - Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1.
    - Phase 1b only: Subject unwilling to limit alcohol consumption
    Subjects who have received intra-articular or systemic corticosteroid injections
    for treatment of acute RA flare (not being part of a regular therapeutic regimen)
    within 4 weeks prior to screening.
    - Currently receiving or had treatment with cyclophosphamide, chlorambucil,
    nitrogen mustard, or any other alkylating agent ≤ 6 months prior to day 1.
    - Prior use of > 1 biologic DMARD and prior use of a biologic DMARD occurred as
    follows:
    • ≤ 10 weeks prior to day 1 for infliximab, abatacept, tocilizumab, golimumab, certolizumab pegol, adalimumab
    • ≤ 4 weeks prior to day 1 for etanercept and anakinra
    • ≤ 6 months for rituximab
    Note: Bio-naïve subjects, defined as subjects who have never received prior biologic therapy for the treatment of RA, are excluded from entering the study in Spain.
    - Currently receiving or had treatment with any of the following ≤ 12 weeks prior to day 1:
    • azathioprine
    • cyclosporine
    • gold
    • mycophenolate mofetil
    • Prosorba column
    • Tacrolimus
    - Phase 2a only: Currently receiving or had treatment with leflunomide ≤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.
    - Phase 2a only: Currently receiving or had treatment with any of the following
    ≤ 4 weeks prior to day 1:
    • hydroxychloroquine
    • sulfasalazine
    • minocycline
    • oral janus kinase inhibitor (eg, tofacitinib, baricitinib)
    • intra-articular, intramuscular or intravenous corticosteroids, including
    adrenocorticotropic hormone
    • intra-articular hyaluronic acid injections
    • live vaccines
    - Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis and/or initiated <4 weeks prior to day 1.
    - Received the following within 12 hours prior to screening or day 1:
    acetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but
    not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone. Subject has taken oxycontin within 24 hours prior to screening or day 1.
    - Phase 1b only: Received any herbal medicines (eg St John’s wort), vitamins, and
    supplements within 4 weeks prior to day 1.
    Relacionados con la enfermedad
    -AR de clase IV según los criterios de respuesta revisados del ACR.
    -Diagnóstico de síndrome de Felty (AR, esplenomegalia y granulocitopenia).
    Otras enfermedades
    -Infección de una prótesis articular en los 3 años anteriores a la inclusión o infección de una articulación nativa en el año anterior a la selección.
    -Infección activa (incluidas infecciones crónicas o localizadas) para las que se hayan indicado agentes antiinfecciosos durante las 4 semanas anteriores al día 1 O presencia de una infección grave, definida como aquella que requiere hospitalización o agentes antiinfecciosos por vía intravenosa durante las 8 semanas anteriores al día 1.
    -Antecedentes conocidos de tuberculosis activa.
    -Prueba de tuberculosis positiva durante la selección, definida como:
    •Derivado proteico purificado positivo (PPD) (≥ 5 mm de induración en las 48 a 72 horas posteriores a la realización de la prueba) O prueba de Quantiferon positiva.
    •Se permite una prueba de PPD positiva y antecedentes de vacunación con el bacilo de Calmette-Guérin si una prueba de Quantiferon y la radiografía torácica son negativas.
    •Se permite una prueba de PPD positiva (sin antecedentes de vacunación con el bacilo de Calmette-Guérin) o una prueba de Quantiferon positiva o indeterminada si los sujetos cumplen con TODO lo siguiente durante la selección:
    No presentan síntomas según la hoja de trabajo de tuberculosis proporcionada por Amgen.
    Tienen antecedentes documentados de un ciclo completo de profilaxis adecuada (tratamiento completo para la tuberculosis latente según el tratamiento estándar local antes de comenzar a recibir el producto en investigación).
    No presentan una exposición conocida a un caso de tuberculosis activa tras la profilaxis más reciente.
    Presentan una radiografía torácica negativa.
    -Positividad para el antígeno de superficie de la hepatitis B, el anticuerpo del núcleo de la hepatitis B (confirmado por la prueba de la reacción en cadena de la polimerasa [RCP] del ADN de la hepatitis B) o el ARN del virus de la hepatitis C detectable mediante RCP (el cribado suele realizarse mediante anticuerpo de la hepatitis C [HepCAb], seguido de ARN del virus de la hepatitis C mediante RCP en caso de positividad para HepCAb). Se permiten antecedentes de vacunación contra la hepatitis B sin antecedentes de hepatitis B.
    -Solo para la fase 1b: resultado positivo para el virus de la inmunodeficiencia humana (VIH) durante la selección o positividad para el VIH conocida. Solo para la fase 2a: antecedentes conocidos de VIH.
    -Análisis de orina positivo para drogas o alcohol durante la selección.
    -Presencia de una o más enfermedades concomitantes significativas según el criterio del investigador, incluidas, entre otras, las siguientes:
    •Diabetes mal controlada o hipertensión.
    •Enfermedad renal crónica en estadio IIIb, IV o V.
    •Insuficiencia cardíaca sintomática (clase II, III o IV de la New York Heart Association).
    •Infarto de miocardio o angina de pecho inestable en los últimos 12 meses antes de la aleatorización.
    •Enfermedad pulmonar crónica grave (por ejemplo, que requiere oxigenoterapia).
    •Esclerosis múltiple o cualquier otra enfermedad desmielinizante.
    •Enfermedad inflamatoria crónica importante o conectivopatía distinta de la AR (por ejemplo, lupus eritematoso sistémico con excepción del síndrome de Sjögren secundario).
    -Tumor maligno, excepto cáncer de piel no melanomatoso o carcinoma cervical o ductal de mama in situ en los últimos 5 años.
    -Antecedentes de abuso de alcohol o drogas durante los 6 meses anteriores a la selección.
    -Solo para la fase 1b: tabaquismo actual o uso de productos con nicotina o tabaco durante los 6 meses anteriores al día 1. Estos tipos de productos son, entre otros, tabaco rapé, tabaco de mascar, puros, cigarrillos electrónicos, cigarrillos, tabaco de pipa o parches de nicotina.
    -Solo para la fase 1b: sujeto que no está dispuesto a reducir el consumo de alcohol a ≤ 1 bebida alcohólica al día y ≤ 3 bebidas alcohólicas a la semana durante la duración del estudio, en donde una bebida es equivalente 350 mL de cerveza normal, 235 a 265 mL de licor de malta, 150 mL de vino o 45 mL de alcohol destilado de 80 grados. Solo para la fase 1b: no estar dispuesto a abandonar el consumo de alcohol durante las 48 horas anteriores a cada visita (incluida la selección).
    Nota: pacientes bio-naïve, definidos como pacientes que nunca han recibido terapia biológica previa para el tratamiento de la AR, están excluidos de participar en el estudio en España.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b
    • Treatment-emergent adverse events.
    • Clinically significant changes in vital signs, laboratory safety tests, and electrocardiograms (ECGs)

    Phase 2a
    • ACR 20 at week 12
    Fase 1b
    -Acontecimientos adversos que aparecen
    durante el tratamiento.
    -Cambios clínicamente significativos en las
    constantes vitales, las pruebas analíticas de
    seguridad y los electrocardiogramas (ECG).
    Fase 2a
    -ACR 20 en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study, Week 12
    en la semana 12.
    E.5.2Secondary end point(s)
    Phase 1b
    • AMG 592 serum concentration and PK parameters including, but not
    limited to, maximum observed concentration (Cmax), the time of maximum observed concentration (Tmax), and area under the concentration-time curve (AUCtau) after the first and last doses. Area under the concentration-time curve
    over the dosing interval will be calculated & reported for each dosing regimen.
    • Anti-AMG 592 antibodies and
    cross-reactivity to IL-2.
    • Anti-AMG 592 and anti-IL 2 neutralizing antibodies
    Phase 2a
    • ACR 50/70 at weeks 12
    • Disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12
    • Disease activity score (28 joint) calculated using the C-reactive protein formula
    (DAS-28-CRP) score and change from baseline at week 12
    Treatment-emergent adverse events.
    • Clinically significant changes in vital signs, laboratory safety tests
    - AMG 592 serum concentration and PK parameters
    Fase 1b
    -Concentración sérica y parámetros PK de
    AMG 592, incluidos, entre otros, la
    concentración máxima observada (Cmáx), el
    tiempo de concentración máxima
    observada (Tmáx) y el área bajo la curva de
    la concentración en función del tiempo
    (AUCtau) después de la primera y la última
    dosis. El área bajo la curva de la
    concentración en función del tiempo sobre
    el intervalo de administración se calculará y
    notificará para cada régimen de
    administración.
    -Anticuerpos anti-AMG 592 y reactividad
    cruzada al IL-2.
    -Anticuerpos neutralizantes anti-AMG 592 y
    anti-IL-2.
    Fase 2a
    -ACR 50/70 en la semana 12.
    -Puntuación de actividad de la enfermedad
    (28 articulaciones) calculada mediante la
    puntuación de la fórmula de velocidad de
    sedimentación de eritrocitos (DAS28-ESR) y
    el cambio respecto al valor basal en la
    semana 12.
    -Puntuación de actividad de la enfermedad
    (28 articulaciones) calculada mediante la
    puntuación de la fórmula de proteína C
    reactiva (DAS-28-CRP) y el cambio respecto
    al valor basal en la semana 12.
    -Acontecimientos adversos que aparecen
    durante el tratamiento.
    -Cambios clínicamente significativos en
    constantes vitales y pruebas analíticas de
    seguridad.
    -Concentración sérica y parámetros PK de
    AMG 592.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout study, Week 12
    en la semana 12.
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b/2a
    fase 1b/2a
    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 No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Czech Republic
    Germany
    Mexico
    New Zealand
    Poland
    Romania
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    último paciente, última visista.
    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 months4
    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 months4
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 137
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-10
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