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    Summary
    EudraCT Number:2017-001368-40
    Sponsor's Protocol Code Number:M-41008-41
    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:2017-07-04
    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 number2017-001368-40
    A.3Full title of the trial
    Open clinical study to assess long-term efficacy and safety of dimethyl fumarate in adults with moderate to severe chronic plaque psoriasis in real practice (DIMESKIN 1 Trial)
    Estudio clínico abierto para evaluar la eficacia y la seguridad a largo plazo de dimetilfumarato en adultos con psoriasis crónica en placas moderada-grave en la práctica clínica (Estudio DIMESKIN 1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the efficacy and safety of dimethyl fumarate in adults with moderate to severe chronic plaque psoriasis in real practice (DIMESKIN 1 Trial)
    Estudio para evaluar la eficacia y la seguridad de dimetilfumarato en adultos con psoriasis crónica en placas moderada-grave en la práctica clínica (Estudio DIMESKIN 1)
    A.3.2Name or abbreviated title of the trial where available
    DIMESKIN 1
    DIMESKIN 1
    A.4.1Sponsor's protocol code numberM-41008-41
    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 SponsorAlmirall 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 supportAlmirall S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic
    B.5.2Functional name of contact pointDepartamento de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-mailensayosclinicos@dynasolutions.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-severe chronic plaque psoriasis
    Psoriasis crónica en placas moderada-grave
    E.1.1.1Medical condition in easily understood language
    Moderate-severe chronic plaque psoriasis
    Psoriasis crónica en placas moderada-grave
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    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 assess the efficacy of dimethylfumarate (DMF) at treatment week 24 by reducing at least 75% in the Psoriasis Area and Severity Index (PASI75) compared to baseline in adults with moderate to severe chronic plaque psoriasis .
    Evaluar la eficacia de dimetilfumarato (DMF) en la semana 24 de tratamiento mediante la reducción de al menos el 75% en el índice Psoriasis Area and Severity Index (PASI75) en comparación con el valor basal en adultos con psoriasis crónica en placas moderada-grave.
    E.2.2Secondary objectives of the trial
    Progress of PASI75, PASI50, PASI90, PASI100 in the treatment with DMF in the 52 weeks.
    Progress of the absolute value of the PASI in the treatment with DMF in the 52 weeks.
    Progress of the Physician's Global Assessment index in patients treated with DMF in the 52 weeks.
    Progress of the Body Surface Area index in DMF treatment in the 52 weeks.
    Progress in Visual Analogue Scale (EVA) of pruritus in the treatment with DMF in the 52 weeks.
    Progress of the Dermatology Life Quality index Index treatment with DMF in the 52 weeks.
    Patients´satisfaction with DMF treatment by EVA after 52 weeks.
    Safety of DMF treatment in the 52 weeks.
    Demographic and clinical features in patients with chronic moderate-severe plaque psoriasis initiating DMF.
    Describe treatments for moderate to severe plaque psoriasis (topical, phototherapy or systemic) prior to initiation with DMF.
    Safety of DMF during treatment.
    Evolución del PASI75, PASI50, PASI90, PASI100 en el tratamiento con DMF en las 52 semanas.
    Evolución del valor absoluto del PASI en el tratamiento con DMF en las 52 semanas.
    Evolución del índice Physician’s Global Assessment en pacientes tratados con DMF en las 52 semanas.
    Evolución del índice Body Surface Area en el tratamiento con DMF en las 52 semanas.
    Evolución en la Escala Visual Analógica (EVA) de prurito en el tratamiento con DMF en las 52 semanas.
    Evolución del índice Dermatology Life Quality Index en el tratamiento con DMF en las 52 semanas.
    Satisfacción de los pacientes del tratamiento con DMF mediante EVA tras 52 semanas.
    Seguridad del tratamiento con DMF en las 52 semanas.
    Características demográficas y clínicas en pacientes con psoriasis crónica en placas moderada-grave que inician DMF.
    Describir los tratamientos para la psoriasis en placas moderada-grave (tópicos,fototerapia o sistémicos) previos al inicio con DMF.
    Seguridad de DMF durante el tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed and personally dated written informed consent
    (2) Male / female
    (3) Aged 18 years or older
    (4) With a diagnosis of chronic plaque psoriasis for at least 6 months before enrolment in the study
    (5) With the severity of psoriasis defined as moderate to severe, as reflected in meeting one of the following criteria:
    - PASI ≥ 10
    - BSA ≥ 10 + PASI ≥ 5
    - DLQI ≥ 10 + PASI ≥ 5
    (6) With general good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the investigator based upon results of medical history, laboratory results and physical examination
    (7) Candidate for systemic treatment.
    (8) With a complete record of at least 6 months of other previous topical and systemic treatments, if any.
    (9) Adhering to the following wash-out periods:
    Topical treatment: Wash-out Period: 2 weeks: Corticosteroids,Vitamin A analogues, Vitamin D analoguess, Tar, Salicylic acid preparations.
    Systemic treatment: Wash-out Period: 4 weeks: Conventional systemic antipsoriatic drugs (methotrexate, cyclosporine, acitretin), apremilast and phototherapy.
    (10) For females of child-bearing potential: a negative serum pregnancy test at screening and willing to use highly effective methods of birth control during the study period.
    1) Consentimiento informado firmado y fechado personalmente
    2) Hombre o mujer
    3) Edad igual o mayor de 18 años
    4) Diagnóstico de psoriasis crónica en placas al menos 6 meses antes de la inclusión en el estudio
    5) Severidad de la psoriasis moderada-grave definida por al menos uno de los siguientes criterios:
    - PASI ≥ 10
    - BSA ≥ 10 y PASI ≥ 5
    - DLQI ≥ 10 y PASI ≥ 5
    6) Buena salud general o con una condición médica estable que no interfiera con la realización del estudio clínico, según determine el investigador en base a los resultados de la historia clínica, de la exploración física y de los resultados de laboratorio.
    7) Candidato/a a tratamiento sistémico de la psoriasis
    8) Registro completo en la historia clínica de al menos 6 meses de otros tratamientos previos
    (tratamiento tópico, fototerapia o tratamientos sistémicos), si los hubiera
    9) Cumplimiento de los siguientes períodos de reposo farmacológico:
    Tratamiento tópico: Período de reposo farmacológico: 2 semanas: Corticosteroides, Análogos de vitamina A, Análogos de vitamina D, Alquitrán de hulla, Preparaciones de ácido salicílico
    Tratamiento sistémico: Período de reposo farmacológico: 4 semanas: Fármacos antipsoriásicos sistémicos convencionales (metotrexato, ciclosporina, acitretina), apremilast y fototerapia.
    10) Para las mujeres en edad fértil: prueba de embarazo en suero negativa en la visita de selección y estar dispuesta a utilizar métodos anticonceptivos adecuados durante el período de estudio.
    E.4Principal exclusion criteria
    1. For females: pregnant or willing to be pregnant or breastfeeding
    2. With a diagnosis of guttate, erythrodermic or pustular psoriasis
    3. With a haematological abnormality as white blood cell (WBC) count 3,0 x 10^9/l or lymphocyte count <1,0 x 10^9/l
    4. With a history of malignancies except for non-melanoma skin cancer
    5. Suffering from significant gastrointestinal problems (ulcers, diarrhoea, etc.)
    6. Known to have severe renal impairment (creatinine clearance <30 mL/min, estimated glomerular filtration rate (eGFR) using CKD-EPI Creatinine Equation or significant proteinuria (3+ or higher) measured by dipstick at screening.
    7. Were detected to have abnormal liver enzymes:
    a) if an enzyme was >3x the upper limit of the normal range (ULN): aspartate amino transferase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine amino transferase (ALT; serum glutamic pyruvic transaminase [SGPT]), gamma-glutamyl-transferase (gamma-GT), alkaline phosphatase (ALP)
    b) if bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary
    8. With active infectious disease
    9. With a history of alcohol or drug abuse
    10. Known suffering from any other immunosuppressive disease or treated with any immunosuppressive drug
    11. Known to be hypersensitive to ingredients of DMF
    12. Known to be intolerant to lactose
    13. Previously enrolled in this study or participating in any drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment.
    14. Previously treated with biologic drug with antipsoriatic activity
    15. Unable to comply with the requirements of the study or who in the opinion of the investigator should not have participated in the study
    1) Mujeres embarazadas, con intensión de quedar embarazadas o estén en período de lactancia.
    2) Con un diagnóstico de psoriasis guttata, eritrodérmica o pustular
    3) Con anomalía hematológica como un recuento de glóbulos blancos inferior a 3,0 x 10^9/l o un recuento de linfocitos inferior a 1,0 x 10^9/l
    4) Con antecedentes de neoplasias, excepto cáncer cutáneo no melanoma.
    5) Que padezca problemas gastrointestinales significativos (úlceras, diarrea, etc.)
    6) Con insuficiencia renal grave en base a tasa de filtrado glomerular estimada [eGFR] inferior a 30 mL/min/1.73 m2 utilizando la fórmula CKD-EPI, o proteinuria significativa [3+ o superior] medida con tira reactiva, en el momento de la selección.
    7) Con detección de enzimas hepáticas anormales:
    a. Si un enzima supera en al menos 3 veces el límite superior del rango normal (LSN): aspartato aminotransferasa/transaminasa oxalacética glutámica sérica (AST/SGOT), alanina aminotransferasa/transaminasa pirúvica glutámica sérica (ALT/SGPT), gamma- glutamil-transferasa (gamma-GT), fosfatasa alcalina (FA)
    b. Si un enzima supera en al menos dos veces el LSN: bilirrubina
    8) Con enfermedad infecciosa activa
    9) Con antecedentes de abuso de alcohol o drogas
    10) Que padezca cualquier otra enfermedad inmunosupresora o tratado con cualquier fármaco inmunosupresor
    11) Conocimiento de hipersensibilidad a los componentes de DMF
    12) Conocimiento de intolerancia a la lactosa
    13) Participando en cualquier ensayo de investigación de fármacos dentro de los 30 días (o cinco semividas, el que sea más largo) antes de la inclusión.
    14) Previamente tratado con fármacos biológicos con actividad antipsoriásica.
    15) Incapaz de cumplir con los requisitos del estudio o que en opinión del investigador no deba participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving a reduction equal to greater than 75% in PASI compared to baseline (PASI75)
    Porcentaje de pacientes que logran una reducción igual o superior al 75% en el PASI en comparación con el valor basal (PASI75)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    - Percentage of patients achieving PASI75 at w4, w8, w12, w36, w48 and w52
    - Percentage of patients achieving PASI50 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PASI90 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PASI100 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PASI ≤ 5 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PASI ≤ 3 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PASI ≤ 1 at w4, w8, w12, w24, w36, w48 and w52
    - Mean % change from baseline in PASI at w4, w8, w12, w24, w36, w48 and w52
    - Mean % change from baseline in BSA at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PGA 0-1 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving PGA ≤ 2 at w4, w8, w12, w24, w36, w48 and w52
    - Mean % change from baseline in DLQI at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving DLQI ≤ 5 at w4, w8, w12, w24, w36, w48 and w52
    - Percentage of patients achieving DLQI 0-1 at w4, w8, w12, w24, w36, w48 and w52
    - Mean % change from baseline in pruritus/pain (VAS) at w4, w8, w12, w24, w36, w48 and w52
    - Mean patient satisfaction (VAS) at w24 and w52
    • Porcentaje de pacientes que alcanzan un PASI75 en las semanas 4, 8, 12, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan un PASI50 (reducción igual o superior al 50% en PASI) en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan un PASI90 (reducción igual o superior al 90% en PASI) en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan un PASI100 (reducción igual o superior al 100% en PASI) en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan una puntuación PASI igual o menor de 5 en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan una puntuación PASI igual o menor de 3 en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan una puntuación PASI igual o menor de 1 en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Cambio porcentual medio con respecto al valor basal en el PASI en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Cambio porcentual medio con respecto al valor basal en el Body Surface Area (BSA) en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan una puntuación de 0-1 en el Physician’s Global Assessment (PGA) en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan una puntuación igual o menor de 2 en el PGA en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Cambio porcentual medio con respecto al valor basal en el Dermatology Life Quality Index (DLQI) en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan un DLQI igual o menor de 5 en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Porcentaje de pacientes que alcanzan un DLQI de 0-1 en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Cambio porcentual medio con respecto al valor basal en la Escala Visual Analógica (EVA) de prurito en las semanas 4, 8, 12, 24, 36, 48 y 52
    • Satisfacción media del paciente según la puntuación obtenida en la EVA en las semanas 24 y 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12, 24, 36, 48 and 52
    Semanas 4, 8, 12, 24, 36, 48 y 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned37
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state300
    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)
    Expected normal treatment.
    Práctica clínica habitual.
    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 Decision2017-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-02
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