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    Summary
    EudraCT Number:2016-002416-41
    Sponsor's Protocol Code Number:201000
    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:2016-12-09
    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 number2016-002416-41
    A.3Full title of the trial
    A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.
    (GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response).
    Estudio aleatorizado, doble ciego, multidosis y controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de la administración de GSK2330672 en el tratamiento del prurito en pacientes con colangitis biliar primaria.
    (GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER Study
    Estudio de dosis y respuesta de GSK2330672 en el tratamiento del prurito en pacientes con colangitis biliar primaria – Estudio GLIMMER
    A.4.1Sponsor's protocol code number201000
    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 SponsorGlaxoSmithKline, 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 supportGSK R&D
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.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 nameGSK2330672
    D.3.2Product code GSK2330672
    D.3.4Pharmaceutical form 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 INNGSK2330672
    D.3.9.1CAS number 1345983-37-0
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.3Other descriptive nameGSK2330672
    D.3.9.4EV Substance CodeSUB121295
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameGSK2330672
    D.3.2Product code GSK2330672
    D.3.4Pharmaceutical form 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 INNGSK2330672
    D.3.9.1CAS number 1345983-37-0
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.3Other descriptive nameGSK2330672
    D.3.9.4EV Substance CodeSUB121295
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 placeboTablet
    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
    Primary biliary cholangitis (PBC)
    colangitis biliar primaria (CBP)
    E.1.1.1Medical condition in easily understood language
    Itch due to primary biliary cholangitis (PBC).
    prurito debido a colangitis biliar primaria (CBP)
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10008604
    E.1.2Term Cholangitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10037087
    E.1.2Term Pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    To investigate the dose response of oral GSK2330672 on itch in PBC patients with moderate to severe pruritus at Baseline.
    Investigar la respuesta a la dosis de GSK2330672 oral en pacientes con CBP y prurito de moderado a severo en el momento basal.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    - To characterize the effects of GSK2330672 compared to placebo on impact of symptoms and quality of life in PBC patients with moderate to severe pruritus at Baseline.
    - To evaluate the effects of GSK2330672 compared to placebo on markers of disease among participants at high risk of PBC progression (i.e., those with serum ALP concentrations ≥1,67xULN and/or total bilirubin concentrations >ULN at Day 1).
    (Please refer to study protocol 201000 for other Secondary Objectives)
    Objetivos Secundarios fundamentales:

    - Caracterizar los efectos de GSK2330672 en comparación con placebo en los síntomas y la calidad de vida de pacientes con CBP y prurito de moderado a severo en el momento basal.

    - Evaluar los efectos de GSK2330672 en comparación con un placebo en los marcadores de la enfermedad en los participantes con alto riesgo de progresión de la CBP (es decir, aquellos con una concentración sérica de fosfatasa alcalina [ALP] ≥1,67xlímite superior normal [LSN] y/o una concentración de bilirrubina total>LSN el día 1).

    (ver Protocolo para una lista completa de los Objetivos Secundarios)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics
    2. Participants who have proven PBC, as demonstrated by having at least 2 of the following:
    • History of sustained increased ALP levels >upper limit of normal (ULN) first recognized at least 6 months prior to the Screening Visit (Note: Sustained ALP elevations at the time of Screening is not required, recognizing that the ALP may have decreased after institution of UDCA therapy as described in inclusion number 4).
    • Documented positive anti-mitochondrial antibody (AMA) titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive).
    • Liver biopsy (at any time in the past) consistent with PBC.
    3. Participants must rate their itch severity as being ≥4 on a 0 to 10 point scale for the majority of time during the 8 weeks prior to the Screening Visit.
    4. Participants who are currently taking UDCA should be on stable doses of UDCA for >8 weeks at time of screening. Participants not taking UDCA due to intolerance may be enrolled 8 weeks after their last dose of UDCA.
    Note: no changes or discontinuation is permitted until completion of the Main Study Period.
    Sex
    5. Male and/or female:
    a. Female participants:
    A female participant is eligible to participate if she is not pregnant (see Appendix 2 of study protocol), not breastfeeding, and at least one of the following conditions applies:
    (i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of study protocol
    OR
    (ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 of study protocol during the treatment period and until at least 4 weeks after the last dose of study treatment.
    Informed Consent
    6. Capable of giving signed informed consent as described in Appendix 3 of study protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    Los pacientes podrán participar en el estudio solo si se cumplen todos los criterios siguientes:
    Edad
    1. El participante debe tener entre 18 y 80 años, ambas edades inclusive, en el momento de la firma del consentimiento informado.
    Tipo de participante y características de la enfermedad
    2. Participantes con CBP confirmada, demostrado con al menos 2 de los siguientes criterios:
    - Antecedente de aumento mantenido de la concentración de ALP > límite superior normal (LSN) detectado por primera vez al menos 6 meses antes de la visita de selección (Nota: No se exige una elevación mantenida de la ALP en el momento de la selección, ya que se reconoce que la ALP puede disminuir después de la instauración del tratamiento con UDCA, como se describe en el criterio de inclusión 4).
    - Título positivo documentado de anticuerpos anti mitocondriales (AMA) (título > 1:40 con inmunofluorescencia o positividad de M2 en el ELISA) o anticuerpos antinucleares específicos de la CBP (patrón central y periférico positivo).
    - Biopsia hepática (en cualquier momento del pasado) compatible con CBP.
    3. Los participantes deben puntuar la intensidad de su prurito como ≥4 en una escala de 0 a 10 puntos la mayor parte del tiempo durante las 8 semanas previas a la visita de selección.
    4. Los participantes que estén tomando UDCA deben haber usado dosis estables de UDCA durante > 8 semanas en el momento de la selección. Los participantes que no tomen UDCA por intolerancia podrán incluirse 8 semanas después de su última dosis de UDCA.
    Nota: No se permitirán cambios ni discontinuaciones hasta finalizar el periodo principal del estudio.
    Sexo
    5. Varones y mujeres:
    a. Mujeres participantes:
    Las mujeres podrán participar si no están embarazadas (véase el Apéndice 2 del Protocolo) o en periodo de lactancia y se aplica al menos una de las condiciones siguientes:
    (i) No son mujeres en edad fértil (MEF) como se define en el Apéndice 2 del Protocolo.
    O
    (ii) Son MEF que siguen las normas anticonceptivas del Apéndice 2 durante el período de tratamiento y hasta al menos 4 semanas después de la última dosis del tratamiento del estudio.
    Consentimiento informado
    6.Capacidad de otorgar el consentimiento informado firmado, tal como se describe en el Apéndice 3, lo que incluye el cumplimiento de los requisitos y restricciones mencionados en el CI y en el protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. Screening total bilirubin >1.5x ULN. Isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
    2. Screening ALT or aspartate aminotransferase (AST) >4x ULN.
    3. Screening estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
    4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
    5. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune hepatitis, biopsy proven non-alcoholic steatohepatitis (NASH) or confirmed hepatocellular carcinoma.
    6. Current symptomatic inflammatory bowel disease, chronic diarrhea, Crohn’s disease or diarrhea related to malabsorption syndromes.
    7. Current symptomatic cholelithiasis or inflammatory gall bladder disease. Participants with history of cholecystectomy ≥3 months before screening may be eligible for enrollment.
    8. Any current medical condition (e.g. psychiatric disorder, senility or dementia), which may affect the participant’s ability to comply with the protocol specified procedures.
    Prior/Concomitant Therapy
    9. Administration of the following drugs at any time during the 3 months prior to screening for the study or planned administration during the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids.
    10. Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3 months prior to screening. Participants may join the study on stable doses of these medications, but no change or discontinuation is permitted until completion of the Main Study Period.
    11. Initiation or increase in dose of any of the following in the 8 weeks prior to screening: rifampicin, naltrexone, naloxone, nalfurafine, or sertraline. Participants may join the study on stable or decreased doses of these medications, but no change in dose is permitted until completion of the Main Study Period.
    12. Bile acid binding resin use: a participant must discontinue use of cholestyramine, colesevelam, colestipol or colestimide prior to the start of the Initial Study Period (no later than Day -2). Note: these drugs may be administered after completion of the Main Study Period, if clinically indicated.
    13. Obeticholic acid use: a participant must discontinue use of obeticholic acid at least 8 weeks prior to the start of the Initial Study Period and may not restart until after the end of the study.
    Prior/Concurrent Clinical Study Experience
    14. Current enrollment or participation within the 8 weeks before start of the Initial Study Period, in any other clinical study involving an investigational study treatment.
    Diagnostic assessments
    15. QTc >450 msec or QTc >480 msec in participants with bundle branch block:
    NOTES:
    • The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is either machine-read or manually over-read.
    • The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.
    16. History of sensitivity to the study treatment or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation in the study.
    17. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
    Los pacientes no podrán participar en el estudio si cumplen cualquiera de los criterios siguientes:
    Trastornos médicos
    1. Bilirrubina total en la selección >1,5 x LSN. Es aceptable una bilirrubina aislada >1,5 x LSN si la bilirrubina está fraccionada y la bilirrubina directa es <35%.
    2. ALT o aspartato aminotransferasa (AST) en la selección >4 x LSN.
    3. Filtración glomerular estimada (FGe) en la selección <45 ml/min/1,73m² según la ecuación de la Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
    4. Antecedente o presencia de descompensación hepática (p. ej., varices hemorrágicas, encefalopatía o ascitis).
    5. Antecedente o presencia de otras enfermedades hepáticas concomitantes, como hepatitis por el virus de la hepatitis B o C (VHB, VHC), colangitis esclerosante primaria (CEP), hepatopatía alcohólica, hepatitis autoinmunitaria evidente, esteatohepatitis no alcohólica (EHNA) demostrada con biopsia o carcinoma hepatocelular confirmado.
    6. Enfermedad inflamatoria intestinal sintomática en la actualidad, diarrea crónica, enfermedad de Crohn o diarrea relacionada con síndromes de malabsorción.
    7. Colelitiasis sintomática o enfermedad inflamatoria de la vesícula biliar en la actualidad. Podrán participar pacientes con antecedente de colecistectomia ≥3 meses antes de la selección.
    8. Cualquier trastorno médico (p. ej., trastorno psiquiátrico, senilidad o demencia) que pueda afectar a la capacidad del participante para someterse a los procedimientos especificados en el protocolo.
    Tratamiento previo/concomitante
    9. Administración de los siguientes fármacos en cualquier momento durante los 3 en meses previos a la selección para el estudio o administración prevista durante el estudio: colchicina, metotrexato, azatioprina o corticosteroides sistémicos.
    10. Inicio o aumento de la dosis de bezafibrato o fenofibrato en cualquier momento durante los 3 meses previos a la selección. Los pacientes podrán incorporarse al estudio con dosis estables de estos medicamentos, pero no se permitirán cambios ni suspensiones hasta el final del periodo principal del estudio.
    11. Inicio o aumento de la dosis de cualquiera de los fármacos siguientes en las 8 semanas previas a la selección: rifampicina, naltrexona, naloxona, nalfurafina o sertralina. Los pacientes podrán incorporarse al estudio con dosis estables o reducidas de estos medicamentos, pero no se permitirán cambios de la dosis hasta el final del periodo principal del estudio.
    12. Uso de resinas de fijación de los ácidos biliares: los participantes deben suspender el uso de colestiramina, colesevelam, colestipol o colestimida antes del comienzo del período inicial del estudio (no más tarde del día -2). Nota: Estos medicamentos se podrán administrar después del final del periodo principal del estudio, si está clínicamente indicado.
    13. Uso de ácido obeticólico: los participantes deben suspender el uso de ácido obeticólico al menos 8 semanas antes del comienzo del período inicial del estudio y no podrán reanudarlo hasta después del final del estudio.
    Experiencia previa/concurrente de estudios clínicos
    14. Participación actual o en las 8 semanas previas al período inicial del estudio, en cualquier otro ensayo clínico en el que se utilice un tratamiento en investigación.
    Evaluaciones diagnósticas
    15. QTc>450 ms, o QTc>480 ms en los participantes con bloqueo de rama.
    NOTAS:
    - El QTc es el intervalo QT corregido por la frecuencia cardíaca según la fórmula de Bazett (QTcB), la fórmula de Fridericia (QTcF) u otro método, con una lectura por el aparato o manual.
    - La fórmula específica que se utilizará para determinar la elegibilidad y la retirada de un paciente se establecerá antes del inicio del estudio. En otras palabras, no se pueden usar varias fórmulas diferentes para calcular el QTc de un participante individual y después usar el valor de QTc más bajo para incluir o retirar a un participante del ensayo.
    Otras exclusiones
    16. Antecedentes de sensibilidad al tratamiento del estudio o a sus componentes o antecedentes de alergias farmacológicas o de otros tipos que, en opinión del investigador o el monitor médico de GSK, contraindiquen la participación en el estudio.
    17. Antecedentes de consumo habitual de alcohol en los 6 meses previos al estudio, definido como un consumo semanal medio de >21 unidades en los varones o > 14 unidades en las mujeres. Una unidad equivale a 8 g de alcohol: aproximadamente 240 ml de cerveza, una copa (125 ml) de vino o 25 ml de licores.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from Baseline at Week 16 in the Mean Worst Daily Itch Score.
    Variación media de la puntuación media del peor prurito diario entre el momento basal y la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    - Mean change from Baseline at Week 16 in PBC-40 Scale.
    In participants meeting the criteria for high risk of PBC progression:
    - Mean change from Baseline at Week 16 in serum ALP concentrations.
    - Proportion of participants having serum ALP concentrations <1.67x ULN and total bilirubin concentrations ≤ULN at Week 16.
    ‚óŹ Mean change from Baseline at Week 16 in serum ALT, AST, GGT, total bilirubin and albumin concentrations and PT/INR.
    - Variación media de la escala PBC-40 entre el momento basal y la semana 16.
    En los participantes que cumplan los criterios de alto riesgo de progresión de la CBP:
    - Variación media de la concentración sérica de ALP entre el momento basal y la semana 16.
    - Proporción de participantes con una concentración sérica de ALP < 1,67 x LSN y una concentración de bilirrubina total ≤ LSN en la semana 16.
    - Variación media entre el momento basal y la semana 16 de las concentraciones séricas de alanina aminotransferasa (ALT), aspartato aminotransferasa (AST), gammaglutamiltranspeptidasa (GGT), bilirrubina total, y del tiempo de protrombina/índice normalizado internacional (TP/INR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    France
    Japan
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente.
    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 months17
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial days0
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 150
    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)
    The Sponsor will not provide treatment after the end of the study; participants should be managed according to their treating physician.
    El promotor no proporcionará tratamiento después del final del estudio, y se tratará a los participantes según el criterio de su médico responsable del tratamiento.
    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 Decision2017-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-15
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