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    Summary
    EudraCT Number:2021-004315-76
    Sponsor's Protocol Code Number:LIBERTY-CPUO-CHIC
    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:2021-11-19
    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 number2021-004315-76
    A.3Full title of the trial
    Master protocol of two randomized, double blind, placebo-controlled, multi-center, parallel group studies to evaluate the efficacy and safety of dupilumab in adult patients with chronic pruritus of unknown origin (CPUO)
    Protocolo maestro de dos estudios aleatorizados, doble ciegos, controlados con placebo, multicéntricos, de grupos paralelos para evaluar la eficacia y la seguridad de dupilumab en pacientes adultos con prurito crónico de origen desconocido (PCOD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of subcutaneous dupilumab for the treatment of adult participants with chronic pruritus of unknown origin (CPUO)
    Eficacia y seguridad de dupilumab por vía subcutánea para el tratamiento de participantes adultos con prurito crónico de origen desconocido (PCOD)
    A.4.1Sponsor's protocol code numberLIBERTY-CPUO-CHIC
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1253-9888
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis, S.A
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493485 94 00
    B.5.6E-mailes-reg-estudiosclinicos@sanofi.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 nameDupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic pruritus of unknown origin (CPUO)
    Prurito crónico de origen desconocido (PCOD)
    E.1.1.1Medical condition in easily understood language
    Chronic pruritus of unknown origin (CPUO)
    Prurito crónico de origen desconocido (PCOD)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level PT
    E.1.2Classification code 10037087
    E.1.2Term Pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study A and B:
    • To demonstrate the efficacy of dupilumab on itch response in participants with CPUO
    Estudio A y B:
    - Demostrar la eficacia de dupilumab en la respuesta al picor en participantes con PCOD
    E.2.2Secondary objectives of the trial
    Study A and B:
    • To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with CPUO
    • To demonstrate the improvement in sleep, anxiety and depression, and health-related quality of life (HRQoL)
    • To evaluate safety outcome measures
    • To evaluate immunogenicity of dupilumab
    Estudio A y B:
    - Demostrar la eficacia de dupilumab en criterios de valoración adicionales del picor en participantes con PCOD
    - Demostrar la mejora en el sueño, la ansiedad y la depresión, y en la calidad de vida relacionada con la salud (CVRS)
    - Evaluar las mediciones de los resultados de seguridad
    - Evaluar la inmunogenicidad de dupilumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.
    - Participants with chronic pruritus for at least 6 months before the screening visit.
    - Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).
    - Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
    - History of insufficient control of the chronic pruritus with prior treatment.
    - Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
    - Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient global impression of severity (PGIS) of pruritus scored “severe” at screening.
    - Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.
    - Participants scored “severe” in the PGIS of pruritus on Day 1.
    - El participante debe tener entre 18 años (o la edad legal de consentimiento en la jurisdicción en la que se realiza el estudio) y 90 años inclusive, en el momento de firmar el consentimiento informado.
    - Participantes con prurito crónico durante al menos 6 meses antes de la visita de selección.
    - Prurito crónico considerado de origen desconocido según la evaluación del investigador al inicio del estudio (excluyendo el prurito crónico secundario a afecciones dermatológicas o sistémicas, de origen neuropático o psicógeno o secundario a fármacos).
    - El prurito crónico debe afectar al menos a 2 de las siguientes zonas del cuerpo: piernas, brazos o tronco.
    - Antecedentes de control insuficiente del prurito crónico con tratamiento previo.
    - Los participantes deben recibir un tratamiento óptimo para las afecciones concomitantes que podrían afectar al prurito (p. ej., diabetes, ferropenia).
    - Los participantes deben tener antecedentes de picor intenso y una puntuación de peor picor ≥7 en la selección en la ECN-PP (la escala de puntuación va del 0 al 10; la puntuación más alta indica un peor picor) y una IGPG del prurito con una puntuación de “grave” en la selección.
    - Los participantes deben tener una puntuación media de peor picor de ≥7 en los 7 días anteriores a la visita de preinclusión y en los 7 días anteriores al día 1 en la ECN-PP.
    - Los participantes obtuvieron una puntuación "grave" en el IGPG del prurito en el día 1.
    E.4Principal exclusion criteria
    - Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study.
    - Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.
    - Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.
    - HIV infection.
    - Severe renal failure (dialysis).
    - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.
    - Known or suspected immunodeficiency.
    - Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
    - History of hypersensitivity or intolerance to non-sedative antihistamines.
    - Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
    - Enfermedad(es) concomitante(s) grave(s) que, a criterio del investigador, que pudieran(n) afectar negativamente a la participación del paciente en el estudio.
    - Pacientes con tuberculosis activa o infección por micobacterias no tuberculosas, o con antecedentes de tuberculosis tratada de forma incompleta, salvo que esté bien documentado por un especialista que el participante ha sido tratado adecuadamente y ahora puede iniciar el tratamiento con un agente biológico.
    - Diagnóstico, con sospecha o con alto riesgo de infección endoparasitaria, y/o uso de fármacos antiparasitarios en las 2 semanas anteriores a la visita de selección.
    - Infección por el VIH.
    - Insuficiencia renal grave (diálisis).
    - Infección crónica o aguda activa que requiera tratamiento con antibióticos sistémicos, antivíricos o antifúngicos en las 2 semanas anteriores a la visita de preinclusión.
    - Inmunodeficiencia conocida o sospechada.
    - Neoplasia activa o antecedentes de neoplasia en los 5 años previos a la visita inicial, excepto carcinoma de cuello uterino in situ completamente tratado y carcinoma de células escamosas o basales de la piel completamente tratado y resuelto.
    - Antecedentes de hipersensibilidad o intolerancia a los antihistamínicos no sedantes.
    - Participación en un estudio clínico previo de dupilumab o haber sido tratado con dupilumab comercial.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 12 ; WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 (“No itch”) to 10 (“Worst imaginable itch”).
    2 - Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12 ; WI-NRS is a PRO comprised of a single item rated on a scale from 0 (“No itch”) to 10 (“Worst imaginable itch”).
    Estudio A: Proporción de participantes con mejoría (reducción) ≥4 en la media semanal de la escala de clasificación numérica del peor picor diario (ECN-PP) desde el inicio hasta la semana 12; (ECN-PP) es un resultado notificado por el paciente (PRO) compuesto por un único elemento valorado en una escala de 0 ("Ningún picor") a 10 ("El peor picor imaginable").
    Estudio B: Proporción de participantes con una mejora (reducción) en la media semanal de la (ECN-PP) diaria en ≥4 desde el inicio hasta la semana 12; la (ECN-PP) es un PRO compuesto por un único ítem valorado en una escala de 0 ("Ningún picor") a 10 ("El peor picor imaginable").
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,2 : Baseline to Week 12
    Desde la visita basal a la semana 12
    E.5.2Secondary end point(s)
    1 - Study A: Proportion of participants who scored “none” or “mild” in Patient Global Impression of Severity (PGIS) of pruritus at Week 12
    2 - Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
    3 - Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12
    4 - Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
    5 - Study A: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 24
    6 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24
    7 - Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24
    8 - Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
    9 - Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24
    10 - Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 12
    11 - Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12
    12 - Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 12
    13 - Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 12
    14 - Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 12
    15 - Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 24
    16 - Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 24
    17 - Study A: Change from baseline in DLQI score at Week 24
    18 - Study A: Change from baseline in the ItchyQoL score at Week 24
    19 - Study A: Change from baseline in HADS total score at Week 24
    20 - Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)
    21 - Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab
    22 - Study B: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 12
    23 - Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
    24 - Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12
    25 - Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 12
    26 - Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 12
    27 - Study B: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12
    28 - Study B: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12
    29 - Study B: Change from baseline in DLQI score at Week 12
    30 - Study B: Change from baseline in the ItchyQoL score at Week 12
    31 - Study B: Change from baseline in HADS total score at Week 12
    32 - Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS
    33 - Study B: Incidence of treatment-emergent ADA against dupilumab
    1.- Estudio A: Proporción de participantes que obtuvieron una puntuación de "ninguno" o "leve" en la impresión global del paciente sobre la gravedad (IGPG) del prurito en la semana 12
    2.- Estudio A: Cambio absoluto con respecto a la visita basal en la media semanal de la ECN-PP diaria en la semana 12
    3. - Estudio A: Cambio porcentual con respecto a la visita basal en la media semanal de la ECN-PP diaria en la semana 12
    4. - Estudio A; Proporción de participantes con mejora (reducción) en la media semanal de la ECN-PP diaria en ≥4 desde el inicio hasta la semana 24
    5. - Estudio A: Proporción de participantes que puntuaron "ninguno" o "leve" en el IGPG de prurito en la semana 24
    6. - Estudio A: Proporción de participantes con una mejora (reducción) en la media semanal de la ECN-PP diaria en ≥4 desde el valor inicial hasta la semana 24
    7. - Estudio A: Tiempo hasta la primera respuesta de ECN-PP ≥4 puntos de reducción respecto al valor inicial en la semana 24
    8. - Estudio A: Cambio absoluto con respecto a la visita basal en la media semanal de la ECN-PP diaria en la semana 24
    9. - Estudio A: Cambio porcentual respecto a la visita basal en el promedio semanal de ECN-PP diario en la semana 24
    10. - Estudio A: Cambio absoluto con respecto al inicio en la media semanal de la escala de valoración numérica (EVN) de los trastornos del sueño diarios en la semana 12
    11. - Estudio A: Porcentaje de cambio con respecto a la visita basal en el promedio semanal de alteraciones diarias del sueño EVN en la semana 12
    12. - Estudio A: Cambio respecto al inicio en la puntuación del Índice de Calidad de Vida en Dermatología (DLQI) en la semana 12
    13. - Estudio A: Cambio desde el inicio en la puntuación de la CdV relacionado con picor (ItchyQoL) en la semana 12
    14. - Estudio A: Cambio respecto al inicio en la puntuación total de la Escala de Ansiedad y Depresión Hospitalaria (HADS) en la semana 12
    15. - Estudio A: Cambio absoluto con respecto a la visita basal en la media semanal de las alteraciones diarias del sueño EVN en la semana 24
    16. - Estudio A: Porcentaje de cambio con respecto a la visita basal en la media semanal de los trastornos diarios del sueño NRS en la semana 24
    17. - Estudio A: Cambio en la puntuación del DLQI en la semana 24 con respecto a la visita basal
    18. - Estudio A: Cambio en la puntuación de CdV relacionada con el picor en la semana 24 con respecto a la visita basal
    19. - Estudio A: Cambio desde el inicio en la puntuación total de la HADS en la semana 24
    20.- Estudio A: Porcentaje de participantes que experimentaron efectos adversos emergentes del tratamiento (AADT) o acontecimientos adversos graves (AAG) desde el inicio hasta el final del estudio (FdE)
    21.- Estudio A: Incidencia de anticuerpos antifármaco (AAF) emergentes del tratamiento contra dupilumab
    22. - Estudio B: Proporción de participantes que puntuaron "ninguno" o "leve" en el IGPG de prurito en la semana 12
    23. - Estudio B: Cambio absoluto con respecto a la visita basal en la media semanal de la ECN-PP diaria en la semana 12
    24. - Estudio B: Cambio porcentual con respecto a la visita basal en la media semanal de la ECN-PP diaria en la semana 12
    25. - Estudio B: Proporción de participantes con una mejora (reducción) en la media semanal de la ECN-PP diaria en ≥4 desde el punto de partida a lo largo del tiempo hasta la semana 12
    26. - Estudio B: Tiempo hasta la primera respuesta de ECN-PP ≥4 puntos de reducción respecto al valor inicial en la semana 12
    27. - Estudio B: Cambio absoluto con respecto a la visita basal en la media semanal de las alteraciones diarias del sueño NRS en la semana 12
    28. - Estudio B: Cambio de porcentaje con respecto a la visita basal en el promedio semanal de alteraciones diarias del sueño NRS en la semana 12
    29. - Estudio B: Cambio en la puntuación del DLQI en la semana 12 con respecto a la visita basal
    30. - Estudio B: Cambio en la puntuación de CdV relacionada con el picor en la semana 12 con respecto a la visita basal
    31. - Estudio B: Cambio desde el inicio en la puntuación total de la HADS en la semana 12
    32. - Estudio B: Porcentaje de participantes que experimentan AADT o AAG desde el inicio hasta el FdE
    33. - Estudio B: Incidencia de AAF emergente del tratamiento contra dupilumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 22 : Week 12
    2, 3, 10, 11, 12, 13, 14, 23, 24, 25, 26, 27, 28, 29, 30, 31 : Baseline to Week 12
    4, 6, 7, 8, 9, 15, 16, 17, 18, 19, 32, 33 : Baseline to Week 24
    5 : Week 24
    20, 21 : Baseline to Week 36
    1, 22: Semana 12
    2, 3, 10, 11, 12, 13, 14, 23, 24, 25, 26, 27, 28, 29, 30, 31: De la visita basal a la semana 12
    4, 6, 7, 8, 9, 15, 16, 17, 18, 19, 32, 33: De la visita basal a la semana 24
    5: Semana 24
    20, 21: De la visita basal a la semana 36.
    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 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) Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Canada
    China
    Japan
    Korea, Republic of
    United States
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    Argentina
    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
    La última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months40
    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: 227
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 226
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 453
    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
    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 Decision2022-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-29
    P. End of Trial
    P.End of Trial StatusOngoing
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