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    Summary
    EudraCT Number:2019-000638-20
    Sponsor's Protocol Code Number:M19-130
    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:2019-09-27
    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 number2019-000638-20
    A.3Full title of the trial
    A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
    Estudio en fase II para investigar la seguridad y la eficacia de ABBV-105 y upadacitinib administrados solos o en combinación (combinación ABBV-599) en pacientes con lupus eritematoso sistémico de actividad moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
    Un estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia y seguridad de ABBV-105 y upadacitinib administrados solos o en combinación (ABBV-599 en Combinación) en sujetos con lupus eritematoso sistémico de actividad moderada a grave
    A.4.1Sponsor's protocol code numberM19-130
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU clinical trials helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwell Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901200103
    B.5.6E-mailabbvie_reec@abbvie.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.3.2Product code ABBV-105
    D.3.4Pharmaceutical form Capsule
    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 INNABBV-105
    D.3.9.1CAS number 1643570-24-4
    D.3.9.2Current sponsor codeABBV-105
    D.3.9.3Other descriptive nameABBV-105
    D.3.9.4EV Substance CodeSUB192702
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 nameUpadacitinib
    D.3.2Product code ABT-494
    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 INNUPADACITINIB
    D.3.9.1CAS number 2050057-56-0
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB187251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 3
    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 nameUpadacitinib
    D.3.2Product code ABT-494
    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 INNUPADACITINIB
    D.3.9.1CAS number 2050057-56-0
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB187251
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    SLE is a chronic disease where the body’s immune system may attack the body’s own skin, joints, kidneys, brain, and/or other organs. Women and people of African descent are more often affected.
    SLE es una enf cróni, el sist inmun del cuerpo ataca la propia piel del cuerpo,
    articul, riñones, cerebro y / u otros órg. Mujeres y pers afrodescendientes son a los que afecta con mayor frecuencia.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib and ABBV-599 vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) at 24 and 48 weeks in subjects with moderately to severely active SLE and to define optimal dose(s) for further development.
    El objetivo principal es evaluar la seguridad y la eficacia de ABBV-105, upadacitinib y ABBV-599 en comparación con un placebo para el tratamiento de los signos y
    síntomas del LES al cabo de 24 y 48 semanas en pacientes con LES de actividad
    moderada a grave y definir las dosis para el desarrollo ulterior.
    E.2.2Secondary objectives of the trial
    Not applicable.
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult male or female, 18 -65 years of age, inclusive, at Screening
    •SLE by ACR 2012 or SLICC Diagnostic Criteria
    • At Screening, must have at least one of the following:
    ∙ ANA+ (titer ≥ 1:80)
    ∙ anti-dsDNA+
    ∙ anti-Smith+
    • SLEDAI-2K ≥ 6 despite background therapy as reported and independently adjudicated (excluding lupus headache and/or organic brain syndrome) (clinical score ≥ 4) at Screening. If 4 points of the required entry points are for arthritis there must also be a minimum of 3 tender and 3 swollen joints
    • Background treatment, stable for 30 days, with prednisone (≤20mg), antimalarials, azathioprine (≤ 150mg), mycophenolate (≤ 2g), leflunomide (≤ 20mg) and/or methotrexate (MTX) (≤ 20mg), cyclosporine, tacrolimus;
    • The combination of background treatment with antimalarial(s) and/or prednisone (or equivalent) and a single, but not multiple, additional immunosuppressant is permitted.
    • Adultos de ambos sexos, de 18 a 65 años, ambos inclusive, en el periodo de
    selección. • LSE por criterios de clasificación ACR 2012 or SLICC • En la visita de
    selección, presencia de al menos uno de los siguientes: · ANA+ (título # 1:80) ·
    anti-ADNdc+ · anti-Smith+ • Puntuación SLEDAI-2K # 6, según una notificación y
    validación independiente (puntuación clínica # 4, excluida la cefalea lúpica o el
    síndrome cerebral orgánico) en la selección. Si 4 de los puntos requeridos para la
    entrada corresponden a la artritis, también debe haber un mínimo de 3
    articulaciones dolorosas y 3 articulaciones inflamadas. • Tratamiento de base,
    estable durante 30 días, en el momento basal con prednisona (# 20 mg),
    antipalúdicos, azatioprina (# 150 mg), micofenolato (# 2 g), leflunomida (# 20 mg),
    ciclosporina, tacrólimus o metotrexato (MTX) (# 20 mg). • Se permite la
    combinación del tratamiento de fondo con antipalúdicos y / o prednisona (o
    equivalente) y un único (pero no múltiple) inmunosupresor adicional.
    E.4Principal exclusion criteria
    • Women of childbearing potential must not have a positive serum pregnancy test at the screening visit and must have a negative urine pregnancy test at baseline prior to the first dose of study drug. Note: Subjects with borderline serum pregnancy tests at Screening must have a serum pregnancy test ≥ 3 days later to document continued lack of positive result.
    • Must not be using IV or IM corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days weeks of planned randomization
    • Must not have active lupus nephritis (progressive Class IV or >1g/d proteinuria) or have undergone induction therapy within the last 6 months.
    • Must not have active neuropsychiatric SLE as defined by the CNS portion of SLEDAI-2K (excluding lupus headache).
    Subjects must be naïve or have discontinued, if not currently benefiting from, the following prior to the first dose of study drug per the applicable washout period below or should be at least 5 times the mean terminal elimination half-life of a drug:
    ∙ ≥6 months for Plasmapheresis
    ∙ ≥3 months for Benlysta
    ∙ ≥1 year for rituximab OR ≥ 6 months if B cells have returned to ≥ 50 B cells per microliter
    ∙ ≥3 months for cyclophosphamide
    • Las mujeres en edad fértil no deben tener una prueba de embarazo en suero
    positiva en el visita de selección y debe tener una prueba de embarazo de orina
    negativa al inicio del estudio antes de la primera dosis de fármaco de estudio. Nota:
    los sujetos con pruebas de embarazo séricas límite en la selección deben tener una
    prueba de embarazo en suero # 3 días después para documentar la falta continua
    de resultados positivos. • No se podrán estar utilizando corticosteroides IV o IM en
    dosis iguales o superiores a un bolo equivalente a 40 mg de prednisona en los 30
    días previos a la aleatorización prevista. • No debe tener nefritis por lupus activa
    (proteinuria progresiva de clase IV o> 1 g / d) o haber estado sometido a terapia de
    inducción en los últimos 6 meses. • No debe tener LES neuropsiquiátrico activo
    como lo define la parte del SNC de SLEDAI-2K (excluida la cefalea lúpica). Los
    sujetos no tienen que haber recibido tratamiento previo o haber suspendido los
    siguientes fármacos antes de la primera dosis de estudio medicamento según el
    período de lavado detallado a continuación ó debe ser al menos 5 veces la vida
    media de eliminación terminal de un fármaco: · #6 meses para la plasmaféresis · #3
    meses para Benlysta · #1 año para rituximab O # 6 meses si las células B han
    regresado a # 50 células B por microlitro · #3 meses para ciclofosfamida
    E.5 End points
    E.5.1Primary end point(s)
    SLE Responder Index (SRI)-4 and steroid dose ≤ 10 mg prednisone equivalent QD.
    Índice de respuesta del LES de 4 (SRI-4) y dosis de esteroides equivalente a #10 mg de prednisona una vez al día (1 v/d).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24.
    Semana 24
    E.5.2Secondary end point(s)
    1. SRI-4 (without ≤ 10 mg prednisone equivalent QD requirement)
    2. SRI-5, -6, -7, -8 (and steroid dose ≤ 10 mg prednisone equivalent QD at Weeks 24 and 48; without ≤ 10 mg prednisone equivalent QD requirement at all other visits)
    3. British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA)
    4. Lupus Low Disease Activity State (LLDAS)
    5. Change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
    6. Steroid burden, assessed as change from baseline
    7. Number of flares by Safety of Estrogens in Lupus Erythematosus National Assessment SELENA SLEDAI flare index, assessed by number and types of flare per patient compared across treatment arms
    8. Time to first flare by SELENA SLEDAI flare index after first study drug administration
    9. Reduction of tender or swollen lupus joints (of those starting with ≥6 joints)
    10. 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score (of those starting with CLASI ≥10)
    11. Change in SLEDAI-2K from Baseline
    12. Change in BILAG from Baseline
    13. Change in Physician’s Global Assessment from Baseline
    14. Change from baseline Functional Assessment of Chronic Illness Therapy – fatigue (FACIT-F) at Weeks 2, 12, 24, and 48
    15. Change from baseline in SF-36 at Weeks 2, 12, 24 and 48
    16. Change from baseline Lupus Quality of Life questionnaire (LupusQoL) at Weeks 2, 12, 24 and 48
    17. Change from baseline Pain NRS at Weeks 2, 12, 24 and 48
    1. SRI-4 (sin necesidad de dosis equivalentes a # 10 mg de prednisona 1 v/d). 2.
    SRI-5, 6, 7 y 8 (y dosis de esteroides equivalente a # 10 mg de prednisona 1 v/d en
    las semanas 24 y 48; sin necesidad de dosis equivalente a # 10 mg de prednisona
    1 v/d en todas las demás visitas). 3. Evaluación combinada del lupus basada en el
    índice BILAG (British Isles Lupus Assessment Group) (BICLA). 4. Estado de
    actividad baja de la enfermedad en el lupus (LLDAS). 5. Variación del índice de
    actividad de la enfermedad en el lupus eritematoso sistémico (SLEDAI)-2K. 6.
    Carga de esteroides, evaluada como la variación con respecto al valor basal. 7.
    Número de brotes según el índice SELENA (evaluación nacional de la seguridad de
    los estrógenos en el lupus eritematoso) SLEDAI, evaluado por el número y los tipos
    de brotes por paciente comparado entre los grupos de tratamiento. 8. Tiempo hasta
    el primer brote según el índice SELENA SLEDAI después de la primera
    administración del fármaco del estudio. 9. Reducción del número de articulaciones
    con lupus dolorosas o inflamadas (en los pacientes que comienzan con # 6
    articulaciones afectadas). 10. Reducción del 50 % en la puntuación de actividad del
    índice CLASI (índice de extensión y gravedad de la enfermedad en el lupus
    eritematoso cutáneo) (en los pacientes que comienzan con una puntuación en el índice CLASI # 10). 11. Variación del índice SLEDAI-2K con respecto al valor basal.
    12. Variación de la puntuación BILAG con respecto al valor basal. 13. Variación de
    la evaluación global por el médico con respecto al valor basal. 14. Variación del
    cuestionario de evaluación funcional del tratamiento de las enfermedades crónicas
    – cansancio (FACIT-F) entre el momento basal y las semanas 2, 12, 24 y 48 15.
    Variación de la puntuación del SF-36 entre el momento basal y las semanas 2, 12,
    24 y 48. 16. Variación del cuestionario de calidad de vida en el lupus (LupusQoL)
    entre el momento basal y las semanas 2, 12, 24 y 48. 17. Variación de la escala
    numérica de valoración (ENV) del dolor entre el momento basal y las semanas 2,
    12, 24 y 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    At all visits unless indicated otherwise.
    En todas las visitas a menos que se indique lo contrario.
    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 Yes
    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 EEA43
    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
    Argentina
    Australia
    Canada
    China
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Poland
    Puerto Rico
    Romania
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the date of the last subject's last contact, which will be a follow-up phone call 30 days after the last dose
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 315
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Those that cannot consent on their own to the study for certain purposes per local regulations. The legally authorized representative would fulfil all statutory requirements for the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 325
    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 patient will return to standard of care.
    El paciente volverá a la atención estándar.
    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 Decision2019-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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