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    Summary
    EudraCT Number:2018-003933-14
    Sponsor's Protocol Code Number:GLPG0634-CL-227
    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:2019-05-21
    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 number2018-003933-14
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.
    Estudio en fase II, aleatorizado, doble ciego, controlado con placebo para evaluar el efecto de filgotinib en los parámetros de semen en varones adultos con artritis reumatoide, artritis psoriásica, espondilitis anquilosante o espondiloartritis axial no radiográfica activas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.
    Un estudio evaluando el efecto de filgotinib en los parámetros de esperma en varones adultos con artritis reumatoide, artritis psoriásica, espondilitis anquilosante o espondiloartritis axial no radiográfica activas.
    A.4.1Sponsor's protocol code numberGLPG0634-CL-227
    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 SponsorGalapagos NV
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal De Wittelaan L11 A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number+34981566801
    B.5.5Fax number+3215342901
    B.5.6E-mailrd@glpg.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 nameFilgotinib
    D.3.2Product code GLPG0634
    D.3.4Pharmaceutical form Film-coated 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 INNFILGOTINIB
    D.3.9.3Other descriptive nameFILGOTINIB
    D.3.9.4EV Substance CodeSUB182273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
    Artritis reumatoide, artritis psoriásica, espondilitis anquilosante o espondiloartritis axial no radiográfica activas.
    E.1.1.1Medical condition in easily understood language
    Rheumatic diseases
    Enfermedades reumáticas
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a ≥ 50% decrease from Baseline in sperm concentration at Week 13
    Evaluar el efecto de filgotinib en la función testicular, determinado por la proporción de sujetos con una reducción, en la semana 13, en la concentración de espermatozoides de ≥50 % desde el inicio.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a ≥ 50% decrease from Baseline in sperm concentration at Week 26
    - To evaluate the effect of filgotinib on sperm total motility at Weeks 13 and 26
    - To evaluate the effect of filgotinib on total sperm count at Weeks 13 and 26
    - To evaluate the effect of filgotinib on the change from Baseline in sperm concentration at Weeks 13 and 26
    - To evaluate the effect of filgotinib on ejaculate volume at Weeks 13 and 26
    - To evaluate the effect of filgotinib on sperm morphology at Weeks 13 and 26
    - Evaluar el efecto de filgotinib en la función testicular, determinado por la proporción de sujetos con una reducción, en la semana 26, en la concentración de espermatozoides de ≥50 % desde el inicio.
    - Evaluar el efecto de filgotinib en la movilidad total de los espermatozoides en las semanas 13 y 26.
    - Evaluar el efecto de filgotinib en el recuento total de espermatozoides en las semanas 13 y 26.
    - Evaluar el efecto de filgotinib en el cambio, desde el inicio, en la concentración de espermatozoides en las semanas 13 y 26.
    - Evaluar el efecto de filgotinib en el volumen de eyaculación en las semanas 13 y 26.
    - Evaluar el efecto de filgotinib en la morfología de los espermatozoides en las semanas 13 y 26.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male between the ages of 21 and 65 (inclusive) on the day of signing informed consent.
    - Diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nrAxSpA) for at least 12 weeks prior to screening, meeting the corresponding specific classification criteria:
    a) RA, American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010
    b) PsA, Classification criteria for Psoriatic Arthritis (CASPAR) criteria
    c) AS or nrAxSpA, Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis
    - For RA, PsA, AS, or nrAxSpA, meets the following criteria:
    a) RA:
    i) Inadequate response or intolerant to an ≥12-week course of csDMARD or biological DMARD (bDMARD) therapy for RA
    ii) Have a Clinical Disease Activity Index (CDAI) >10 at screening
    b) PsA
    i) Inadequate response or intolerant ≥12-weeks’ course of csDMARD or bDMARD therapy for PsA
    ii) Have a Disease Activity in Psoriatric Arthritis (DAPSA) score >14 at screening
    c) Axial Spondyloarthritis (applicable to those with diagnosis of AS or nrAxSpA)
    i) Inadequate response or intolerant to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), which may include cyclooxygenase-2 (COX-2 inhibitors) prescribed for a total period of ≥4 weeks OR to an at least 12 weeks’ course of csDMARD or bDMARD therapy for spondyloarthritis
    ii) Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 at screening
    iii) At screening, subjects should have a C-reactive protein (CRP) >0.3 mg/dL OR sacroiliitis according to the modified New York (NY) criteria OR a history of active inflammation on magnetic resonance imaging (MRI) consistent with sacroiliitis within two year of screening
    - If using csDMARD therapy, subjects are permitted to use one of the following drugs, alone or in combination and must have been on a stable dose of the drug for at least 4 weeks prior to Baseline and remain on a stable dose for the first 13 weeks in the study (stable dose in all cases is defined as no change in prescription):
    a) MTX oral or parenteral up to 25 mg/week (with concomitant use of folic or folinic acid supplementation as per local standard of care)
    b) Leflunomide (LEF) up to 20 mg/day orally
    c) Hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day orally
    d) Apremilast orally up to 30 mg twice daily orally
    Note that sulfasalazine is not permitted at any time, beginning 26 weeks prior to Screening until the end of the study, and cannot be included in the standard of care arthritis regimen, due to its potential impact on semen parameters
    - The mean of 2 separate semen samples collected at Screening must meet the following minimum criteria: semen volume ≥ 1.5 mL, total sperm per ejaculate ≥ 39 million, sperm concentration ≥ 15 million per mL, sperm total motility ≥ 40% and normal sperm morphology ≥ 30%
    - LH, FSH, inhibin B, and total testosterone values within 20% of laboratory reference ranges at Screening

    This list only contains the key inclusion criteria.
    - Sujetos con edades comprendidas entre los 21 y los 65 años (ambos incluidos) en el día de la firma del consentimiento informado.
    - Diagnóstico de la artritis reumatoide (AR), artritis psoriásica (PsA), espondilitis anquilosante (AS) o la espondiloartritis axial no radiográfica (nr-AxSpA) durante, al menos, 12 semanas antes de la selección, una vez cumplidos los correspondientes criterios específicos de clasificación:
    a) AR: Colegio Estadounidense de Reumatología (ACR)/Liga Europea contra el Reumatismo (EULAR) 2010.
    b) PsA, Criterios de clasificación para la artritis psoriásica (CASPAR).
    c) AS o nr-AxSpA: Criterios de evaluación de la Sociedad Internacional de Espondiloartritis (ASAS) para la espondiloartritis axial.
    - Para la AR, PsA, AS o nr-AxSpA, cumple los siguientes criterios:
    a) AR:
    i) Respuesta inadecuada o intolerancia a un tratamiento de ≥12 semanas con FARMEsc o FARME biológicos (FARMEb) para el tratamiento de la AR.
    ii) Tener un índice clínico de actividad de la enfermedad (CDAI) >10 en la selección.
    b) PsA:
    i) Respuesta inadecuada o intolerancia a un tratamiento de ≥12 semanas con terapia FARMEsc o FARMEb para el tratamiento de la PsA.
    ii) Tener una puntuación >14 en la actividad de la enfermedad de la artritis psoriásica (DAPSA) en la selección.
    c) Espondiloartritis axial (aplicable a aquellos pacientes con diagnóstico de AS o nr-AxSpA):
    i) Respuesta inadecuada o intolerancia a, al menos, 2 fármacos antiinflamatorios no esteroides (AINE), lo que puede incluir la ciclooxigenasa-2 (inhibidores de la COX-2) prescrita, para un periodo total de ≥4 semanas; O BIEN, a un tratamiento de, al menos, 12 semanas con FARMEsc o FARMEb para el tratamiento de la espondiloartritis.
    ii) Tener un Índice de Bath para la actividad de la enfermedad espondilitis anquilosante (BASDAI) de ≥4 en la selección.
    iii) Durante la selección, los sujetos deben tener una concentración de la proteína C reactiva (PCR) de >0,3 mg/dl; O BIEN, sacroileitis conforme a los criterios modificados de Nueva York (NY); O BIEN, antecedentes de inflamación activa en la resonancia magnética (RM) que obedece a sacroileitis, en un plazo de dos años desde la selección.
    - Si se utiliza la terapia con FARMEsc, se permite a los pacientes el uso de uno de los siguientes fármacos, en monoterapia o en combinación; asimismo, deben haber recibido una dosis estable del fármaco durante, al menos, 4 semanas antes del inicio del estudio y permanecer en una dosis estable durante las primeras 13 semanas del estudio (en todos los casos, se entiende «dosis estable» como la ausencia de cambios en la prescripción):
    a) MTX por vía oral o parenteral hasta 25 mg/semana (con uso concomitante del suplemento de ácido fólico o folínico, según la práctica clínica habitual).
    b) Leflunomida (LEF) hasta 20 mg/día, por vía oral.
    c) Hidroxicloroquina hasta 400 mg/día, o cloroquina hasta 250 mg/día, por vía oral.
    d) Apremilast, por vía oral, hasta un máximo de 30 mg dos veces al día.
    Tenga en cuenta que la sulfasalazina no está permitida en ningún momento, desde las 26 semanas anteriores a la selección hasta el final del estudio; tampoco puede incluirse en la práctica clínica habitual del tratamiento de la artritis, debido a su posible efecto sobre los parámetros de semen.
    - La media de 2 muestras separadas de semen recogidas en la selección debe cumplir los siguientes criterios mínimos: volumen de semen, ≥1,5 ml; espermatozoides totales por eyaculación, ≥39 millones; concentración de espermatozoides, ≥15 millones por ml; movilidad total de los espermatozoides, ≥40 %; y morfología normal de los espermatozoides, ≥30 %.
    - Los intervalos de referencia del laboratorio de LH, FSH, inhibina B y testosterona total deben situarse dentro del 20 % en la selección.

    Esta lista solo contiene los criterios de inclusión principales.
    E.4Principal exclusion criteria
    - Previously documented problems with male reproductive health including, but not limited to, known hypothalamic-pituitary disorders (eg, pituitary macroadenomas, pituitary infarction, hyperprolactinemia, panhypopituitarism), primary hypogonadism (eg, cryptorchidism, Klinefelter’s syndrome)
    - Prior diagnosis of male infertility (including reduced fertility), or history of anti-sperm antibodies
    - Clinically significant (per judgment of investigator) varicocele or spermatocele
    - History of radiation to the testicles
    - History of clinically significant trauma to, or surgery on, the testicles, including vasectomy
    - Current prior treatment with antiandrogen therapy (including but not limited to spirinolactone, oral ketoconazole, or cyproterone acetate), or treatment within 4 weeks of Screening
    - Presence of disorders of sperm transport, including but not limited to retrograde ejaculation and immotile cilia syndrome.
    - Clinically significant urinary tract infection, prostatitis, epididymitis, including sexually transmitted infection within 4 weeks of Screening
    - Any sexual dysfunction of a nature that would prevent sperm collection in accordance with protocol guidance (phosphodiesterase inhibitors, however, are permitted during the study)

    This list only contains the key exclusion criteria.
    Problemas en la salud del aparato reproductor masculino previamente documentados, incluidos, entre otros: trastornos hipotálamo-hipofisarios ya conocidos (p. ej., macroadenoma hipofisario, infarto hipofisario, hiperprolactinemia o panhipopituitarismo), hipogonadismo primario (p. ej., criptorquidia o síndrome de Klinefelter).
    - Diagnóstico anterior de esterilidad masculina (incluida reducción de la fertilidad) o antecedentes de anticuerpos antiespermatozoides.
    - Varicocele o espermatocele clínicamente significativa (a juicio del investigador).
    - Antecedentes de radiación en los testículos.
    - Antecedentes de traumatismo clínicamente significativo en los testículos, o cirugía de estos, incluida la vasectomía.
    - Tratamiento actual y previo con antiandrógenos (incluidos, entre otros, espirinolactona, ketoconazol por vía oral, o acetato de ciproterona), o tratamiento dentro de las 4 semanas siguientes a la selección.
    - Presencia de trastornos en la movilidad del esperma, incluidos, entre otros, la eyaculación retrógrada y el síndrome de inmovilidad ciliar.
    - Infección de las vías urinarias clínicamente significativa, prostatitis, epididimitis, incluida infección de transmisión sexual, dentro de las 4 semanas desde la selección.
    - Cualquier disfunción sexual de naturaleza tal que pudiera impedir la obtención de espermatozoides, de conformidad con las directrices del protocolo (los inhibidores de la fosfodiesterasa, sin embargo, están permitidos durante el estudio).

    Esta lista solo contiene los criterios de exclusión principales.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with a ≥ 50% decrease from Baseline in sperm concentration at Week 13.
    Proporción de sujetos con una reducción en la concentración de espermatozoides de ≥50 % desde el inicio en la semana 13.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at week 13.
    Al inicio y en la semana 13.
    E.5.2Secondary end point(s)
    - The proportion of subjects with a ≥ 50% decrease from Baseline in sperm concentration at Week 26
    - Change from Baseline in percent motile sperm at Weeks 13 and 26
    - Change from Baseline in total sperm count at Weeks 13 and 26
    - Change from Baseline in sperm concentration at Weeks 13 and 26
    - Change from Baseline in ejaculate volume at Weeks 13 and 26
    - Change from Baseline in percent normal sperm morphology at Weeks 13 and 26
    - Proporción de sujetos con una reducción en la concentración de espermatozoides de ≥50 % desde el inicio en la semana 26.
    - Cambio, desde el inicio, en el porcentaje de espermatozoides móviles en las semanas 13 y 26.
    - Cambio, desde el inicio, en el total de espermatozoides en las semanas 13 y 26.
    - Cambio, desde el inicio, en la concentración de espermatozoides en las semanas 13 y 26.
    - Cambio, desde el inicio, en el volumen de eyaculación en las semanas 13 y 26.
    - Cambio, desde el inicio, en el porcentaje de la morfología normal de los espermatozoides en las semanas 13 y 26.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, at week 13 and at week 26
    Al inicio y en las semana 13 y 26.
    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 No
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Open label after week 13
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Czech Republic
    Estonia
    Georgia
    Germany
    India
    Latvia
    Moldova, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    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
    End of Study is reached when the last scheduled study visit occurred. This can be a Week 156 visit, a Follow-up visit, or the last visit of a Monitoring Phase.
    El final del estudio se alcanzará cuando se produzca la última visita programada del estudio. Esto puede ser en la visita de la semana 156, en una visita de seguimiento o en la última visita de la fase de supervisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 250
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 106
    F.4.2.2In the whole clinical trial 250
    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
    Ninguno
    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 Decision2019-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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