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    Summary
    EudraCT Number:2017-001508-31
    Sponsor's Protocol Code Number:R1500-CL-1643
    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:2018-02-02
    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 number2017-001508-31
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
    Estudio aleatorizado, doble ciego, controlado con placebo, de la seguridad y la eficacia de diferentes dosis y pautas posológicas de evinacumab en pacientes con hipercolesterolemia crónica a pesar del tratamiento hipolipidemiante máximo tolerado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which patients will be assigned, by chance, to receive either the active drug Evinacumab or a dummy-drug, (a placebo), without anybody knowing what that are assigned to, to determine safety and efficacy of different dose regimens of Evinacumab in patients with persistent high cholesterol despite taking the maximum tolerated lipid modifying therapy
    Un estudio en el que se asignará a los pacientes al azar para recibir el fármaco activo evinacumab o un fármaco simulado (un placebo) sin que nadie sepa qué se les ha asignado, para determinar la seguridad y la eficacia de distintas pautas posológicas de evinacumab en pacientes con el colesterol alto de forma persistente a pesar de tomar la dosis máxima tolerada del tratamiento antidislipidémico.
    A.4.1Sponsor's protocol code numberR1500-CL-1643
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03175367
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEvinacumab (REGN1500)
    D.3.2Product code REGN1500
    D.3.4Pharmaceutical form Powder and solvent 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 INNEvinacumab
    D.3.9.1CAS number 1446419-85-7
    D.3.9.2Current sponsor codeREGN1500
    D.3.9.3Other descriptive nameEVINACUMAB
    D.3.9.4EV Substance CodeSUB181899
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 nameEvinacumab (REGN1500)
    D.3.2Product code REGN1500
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEvinacumab
    D.3.9.1CAS number 1446419-85-7
    D.3.9.2Current sponsor codeREGN1500
    D.3.9.3Other descriptive nameEVINACUMAB
    D.3.9.4EV Substance CodeSUB181899
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
    hipercolesterolemia crónica a pesar del tratamiento hipolipidemiante máximo tolerado
    E.1.1.1Medical condition in easily understood language
    Hypercholesterolemia, also called dyslipidemia, is the presence of high
    levels of cholesterol in the blood, despite previous and concomitant treatment with Maximally Tolerated Lipid Modifying Therapy
    La Hipercolesterolemia (dyslipidemia), es la presencia de un alto nivel de colesterol en sangre a pesar de haber recibido dosis máx. tolerada de un tratamiento antidislipidémico previo y concomitante
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with LDL-C ≥ 100 mg/dL (2.59 mmol/L), despite maximally tolerated statin and PCSK9 inhibitor antibody therapy.
    El objetivo principal del estudio es evaluar la reducción del colesterol de lipoproteínas de baja densidad (C-LDL) mediante evinacumab en comparación con placebo después de 16 semanas en pacientes con hipercolesterolemia primaria (hipercolesterolemia familiar heterocigótica [HFHe], o no HFHe con antecedentes de enfermedad cardiovascular aterosclerótica clínica [ECVA clínica]) con C-LDL ≥ 100 mg/dl (2,59 mmol/l) a pesar del tratamiento con anticuerpos inhibidores de estatinas y proproteína convertasa subtilisina/kexina tipo 9 (PCSK9) máximo tolerado.
    E.2.2Secondary objectives of the trial
    • To evaluate the dose-response effect of evinacumab on other lipid parameters (ie, ApoB, non-high-density lipoprotein cholesterol [non-HDL-C], total cholesterol [TC], Lp (a), triglycerides [TGs], ApoCIII), and total ANGPTL3 in patients with primary hypercholesterolemia
    • To evaluate the safety and tolerability of SC and IV doses of evinacumab in patients with primary hypercholesterolemia
    • To assess systemic serum concentrations of evinacumab in patients with primary hypercholesterolemia
    • To evaluate the potential development of anti-evinacumab antibodies
    • Evaluar el efecto de dosis-respuesta de evinacumab sobre otros parámetros lipídicos (es decir, apolipoproteína [Apo] B, colesterol de lipoproteínas de no alta densidad [C-no-HDL], colesterol total [CT], Lp(a), triglicéridos [TG], ApoCIII) y total de proteína 3 similar a la angiopoyetina (ANGPTL3) en pacientes con hipercolesterolemia primaria.
    • Evaluar la seguridad y tolerabilidad de dosis subcutáneas (s.c.) e intravenosas (i.v.) de evinacumab en pacientes con hipercolesterolemia primaria.
    • Evaluar las concentraciones séricas sistémicas de evinacumab en pacientes con hipercolesterolemia primaria.
    • Evaluar el desarrollo potencial de los anticuerpos antievinacumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional genomic sub-study will be conducted to identify genomic associations with clinical or biomarker response, other clinical outcome measures and possible AEs.
    Title : Genomic sub-study optional.
    Version and date: R1500-CL-1643.01, 22Jun2017
    Objectives: The purpose of the pharmacogenomic analyses is to identify genomic associations with clinical or biomarker response, other clinical outcome measures and possible AEs. In addition, associations between genomic variants and prognosis or progression of as well as other diseases may also be studied. These data may be used or combined with data collected from other studies to identify and validate genomic markers related to the study drug or and other diseases. Analyses may include sequence determination or single nucleotide polymorphism studies of candidate genes and surrounding genomic regions. Other methods, including whole exome sequencing, whole-genome sequencing, DNA copy number variation. The list of methods may be expanded to include novel methodology that may be developed during the course of this study or sample storage period.
    Se llevará a cabo un subestudio de genómica optativo para detectar asociaciones genómicas con respuesta clínica o en los biomarcadores, otras medidas de los resultados clínicos y posibles AA.
    Título: Subestudio de genómica optativo.
    Versión y fecha: R1500-CL-1643.01, 22jun2017
    Objetivos: La finalidad de los análisis de farmacogenómica es la de detectar asociaciones genómicas con respuesta clínica o en los biomarcadores, otras variables clínicas y posibles AA. Asimismo, es posible que también se estudien las asociaciones entre variantes genómicas y su pronóstico o evolución, así como otras enfermedades. Estos datos pueden usarse o combinarse con los recogidos en otros estudios para identificar y validar los marcadores genómicos relacionados con el fármaco del estudio o con otras enfermedades. Los análisis pueden incluir la determinación de secuencias o estudios de polimorfismos de un solo nucleótido de genes candidatos y las regiones genómicas circundantes. Otros métodos, como la secuenciación del exoma completo, la del genoma completo o la variación en el número de copias de ADN. La lista de métodos se puede ampliar para incluir nuevos métodos que se puedan llevar a cabo en el transcurso de este estudio o en el periodo de almacenamiento de las muestras
    E.3Principal inclusion criteria
    1. Men and women, ages 18 through 75 at the screening visit
    2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
    3. A history of clinical ASCVD, for those patients who are non-HeFH.
    4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
    5. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit
    6. Serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)
    7. Provide signed informed consent
    1. Hombres y mujeres que tengan entre 18 y 75 años en la visita de selección
    2. Diagnóstico de hipercolesterolemia primaria, tanto HFHe como no HFHe con ECVA sintomática
    3. Antecedentes de ECVA sintomática en aquellos pacientes que presenten hipercolesterolemia primaria no HFHe.
    4. Recibir una estatina estable a la dosis máxima tolerada (± ezetimiba) durante al menos 4 semanas en la selección
    5. Recibir alirocumab 150 mg s. c. c2s, O BIEN evolocumab 140 mg s. c. c2s o 420 mg s. c. c4s durante al menos 8 semanas antes de la visita de selección
    6. C-LDL sérico >=100 mg/dl en la selección (se permite 1 repetición del análisis)
    7. Proporcionar un consentimiento informado firmado
    E.4Principal exclusion criteria
    1. Known history of homozygous FH (clinically, or by previous genotyping)
    2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
    3. Newly diagnosed diabetes (within 3 months prior to screening)
    4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)
    5. Laboratory findings during screening period (not including randomization labs):
    - Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus
    - Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)
    - Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential
    - Estimated glomerular filtration rate < 30 mL/min/1.73 m^2
    - TSH > 1.5 x upper limit of normal (ULN)
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
    6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization
    7. History of heart failure (New York Heart Association [NYHA] Class II-IV) within 12 months before screening
    8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening
    9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)
    10. Having received LDL apheresis within 2 months before screening
    11. Pregnant or breast-feeding women
    12. Women of childbearing potential who are unwilling to practice a highly effective birth control method
    13. Sexually active men unwilling to use acceptable birth control
    1. Antecedentes conocidos de HF homocigótica (obtenidos clínicamente o mediante genotipado previo)
    2. Presencia de cualquier enfermedad endocrina de importancia clínica y no controlada que influya en los lípidos o en las lipoproteínas en suero
    3. Diagnóstico reciente de diabetes (en los 3 meses anteriores a la selección)
    4. Uso de fármacos para la tiroides (excepto los tratamientos sustitutivos que se hayan mantenido estables al menos durante 12 semanas antes de la selección)
    5. Resultados analíticos durante la fase de selección (sin incluir los análisis de la aleatorización):
    — Triglicéridos >400 mg/dl (>4,52 mmol/l) para los pacientes sin antecedentes conocidos de diabetes mellitus; O BIEN triglicéridos >300 mg/dl (>3,39 mmol/l) para los pacientes con antecedentes conocidos de diabetes mellitus
    — Prueba positiva para el antígeno de superficie del virus de la hepatitis B o para anticuerpos contra el virus de la hepatitis C (asociada a resultados positivos para ácido ribonucleico [ARN] del VHC en la reacción en cadena de la polimerasa)
    — Resultados positivos para gonadotropina coriónica humana β o en una prueba de embarazo en orina para las mujeres con capacidad de concebir
    — Filtración glomerular estimada <30 ml/min/1,73 m^2
    — TSH >1,5 x límite superior de la normalidad (LSN)
    — Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >2 x LSN
    6. Presión arterial sistólica >160 mmHg o presión arterial diastólica >100 mmHg en la visita de selección o en el momento de la aleatorización
    7. Antecedentes de insuficiencia cardiaca (clases II-IV de la Asociación de Cardiología de Nueva York [NYHA]) en los 12 meses anteriores a la selección
    8. Antecedentes de IM, angina de pecho inestable que requiera hospitalización, cirugía de RVC, ACTP, arritmia cardiaca sin controlar, cirugía o stent carotídeos, accidente cerebrovascular, AIT, revascularización carotídea, procedimiento o intervención quirúrgica endovascular por vasculopatía periférica en los 3 meses previos a la selección
    9. Antecedentes de cáncer en los 5 años anteriores (a excepción del cáncer cutáneo basocelular, cáncer cutáneo de células escamosas o cáncer de cuello uterino localizado tratados adecuadamente)
    10. Haberse sometido a alguna aféresis de LDL en los 2 meses anteriores a la selección
    11. Mujeres embarazadas o en periodo de lactancia
    12. Mujeres con capacidad de concebir que no estén dispuestas a utilizar métodos anticonceptivos de gran eficacia
    13. Hombres sexualmente activos que no estén dispuestos a usar métodos anticonceptivos válidos
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in calculated low-density lipoprotein cholesterol (LDL-C) from baseline to week 16 in the intent-to-treat (ITT) population, using all LDL-C values regardless of adherence to treatment
    Cambio porcentual en el C-LDL calculado desde el inicio hasta la semana 16 en la población por intención de tratar (IdT), usando todos los valores de C-LDL independientemente de la adherencia al tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 16
    Inicio y semana 16
    E.5.2Secondary end point(s)
    • Percent change in ApoB from baseline to week 16
    • Percent change in non-HDL-C from baseline to week 16
    • Percent change in TC from baseline to week 16
    • Proportion of patients with ≥ 30% reduction in calculated LDL-C at week 16
    • Proportion of patients with ≥ 50% reduction in calculated LDL-C at week 16
    • Percent change in TGs from baseline to week 16
    • Percent change in Lp(a) from baseline to week 16
    • Proportion of patients with calculated LDL-C < 100 mg/dL (2.59 mmol/L) at week 16
    • Proportion of patients with calculated LDL-C < 70 mg/dL (1.181 mmol/L) at week 16
    • Percent change in calculated LDL-C, ApoB, non-HDL-C, TC, TG, and Lp(a) from baseline to week 24 (only applicable to those patients receiving IV route of study treatment administration)
    • Cambio porcentual en ApoB desde el inicio hasta la semana 16.
    • Cambio porcentual en C-no-HDL desde el inicio hasta la semana 16.
    • Cambio porcentual en CT desde el inicio hasta la semana 16.
    • Proporción de pacientes con una reducción >= 30 % en el C-LDL calculado en la semana 16.
    • Proporción de pacientes con una reducción >= 50 % en el C-LDL calculado en la semana 16.
    • Cambio porcentual en TG desde el inicio hasta la semana 16.
    • Cambio porcentual en Lp(a) desde el inicio hasta la semana 16.
    • Proporción de pacientes con una reducción < 100 mg/dl (2,59 mmol/l) en el C LDL calculado en la semana 16.
    • Proporción de pacientes con una reducción < 70 mg/dl (1,181 mmol/l) en el C-LDL calculado en la semana 16.
    • Cambio porcentual en C-LDL calculado, ApoB, C-no-HDL, CT, TG y Lp(a) desde el inicio hasta la semana 24 (solo aplicable a aquellos pacientes que reciben la administración del tratamiento del estudio por vía i.v.).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 16 for all endpoints except last endpoint regarding the Percent change in calculated LDL-C, ApoB, non-HDL-C, TC, TG, and Lp(a) that will be calculated on Baseline and week 24
    Inicio y en la Semana 16 para todos los criterios de valoración, excepto el último criterio de valoración en cuanto al cambio porcentual en los valores de C-LDL calculado, Apo-B, C-no-HDL, CT, TG y Lp(a), que se calcularán al inicio y en la Semana 24
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Estudio de búsqueda de dosis para evaluar diversas dosis de pautas s. c. e i. v.
    dose ranging study to assess varying doses of SC and IV regimens
    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 trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Canada
    Czech Republic
    Denmark
    Israel
    Italy
    Netherlands
    New Zealand
    Norway
    Poland
    Russian Federation
    South Africa
    Sweden
    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
    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 years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days10
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 252
    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 are no plans for treatment or care after the subject has ended
    the participation in the trial. Care will be determined and provided by
    subject's physician.
    No hay planes de tratamiento o cuidado después de que el paciente haya terminado la participación en el ensayo. La atención será determinada y proporcionada por el médico del paciente.
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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