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    Summary
    EudraCT Number:2018-003748-22
    Sponsor's Protocol Code Number:MRG106-11-203
    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:2019-04-12
    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 number2018-003748-22
    A.3Full title of the trial
    PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study
    PRISM: Un estudio de ampliación abierto y multicéntrico para investigar la eficacia y seguridad de Cobomarsen (MRG-106) después del tratamiento sistémico en sujetos con linfoma cutáneo de células T (CTCL), subtipo de micosis fungoide (MF) y que hayan completado el estudio SOLAR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects with Mycosis Fungoides, who have completed the SOLAR Study
    PRISM: Eficacia y seguridad de Cobomarsen (MRG-106) en sujetos con micosis fungoide y que hayan completado el estudio SOLAR
    A.3.2Name or abbreviated title of the trial where available
    PRISM
    A.4.1Sponsor's protocol code numberMRG106-11-203
    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 SponsormiRagen Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportmiRagen Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmiRagen Therapeutics, Inc.
    B.5.2Functional name of contact pointSOLAR Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address6200 Lookout Road
    B.5.3.2Town/ cityBoulder
    B.5.3.3Post codeCO 80301
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34691765 107
    B.5.6E-mailSOLAR@miragen.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1872
    D.3 Description of the IMP
    D.3.1Product namecobomarsen
    D.3.2Product code MRG-106
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBOMARSEN
    D.3.9.1CAS number 1848257-52-2
    D.3.9.2Current sponsor codeMRG-106
    D.3.9.4EV Substance CodeSUB192820
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number141
    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
    Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
    Cutáneo de Células T (CTCL), micosis fungoide (MF) Subtipo
    E.1.1.1Medical condition in easily understood language
    A cancer of the lymphatic system that affects the skin
    Cáncer del Sistema linfático que afecta a la piel
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028483
    E.1.2Term Mycosis fungoides
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of
    cobomarsen in subjects with MF who have shown disease progression
    following treatment with vorinostat in the SOLAR study.
    El objetivo principal del estudio es evaluar la eficacia de cobomarsen en sujetos con MF en lo que sehaya confirmado la progresión de la enfermedad después del tratamiento con vorinostat en el estudio SOLAR.
    E.2.2Secondary objectives of the trial
    • Investigate the safety and tolerability of cobomarsen in subjects with MF.
    • Investigar la seguridad y tolerabilidad de cobomarsen en sujetos con MF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must provide written informed consent (signed and dated), and any
    authorizations required by law and be able to comply with all study
    requirements.
    2. Must have participated in the comparator arm of the SOLAR clinical
    trial and completed the study (confirmed disease progression). Subjects
    who discontinued from SOLAR for any reason other than confirmed
    disease progression on the comparator arm are not eligible.
    3. Meets the following criteria per the central laboratory at Screening:
    a. Calculated creatinine clearance ≥ 40 mL/min using 24-hour creatinine
    clearance OR modified Cockcroft-Gault equation (using ideal body mass
    [IBM] instead of mass).
    b. AST and ALT ≤ 2.5 × the ULN; bilirubin ≤ 1.5 × ULN (except subjects
    with Gilbert's Syndrome who may have bilirubin ≤ 3.0 × ULN following
    discussion with the Sponsor).
    4. Females who had a menstrual cycle within 2 years of Screening must
    have a negative serum pregnancy test at Screening and a negative urine
    pregnancy test on their first dosing day.
    5. Subjects of childbearing potential must agree to use highly effective
    methods of contraception.
    1. Debe presentar el consentimiento informado por escrito (firmado y fechado) y cualquier autorización que se solicite legalmente además de poder cumplir con todos los requisitos del estudio.
    2. Debe haber participado en el grupo comparativo del ensayo clínico SOLAR y haber completado el estudio (con la confirmación de la progresión de la enfermedad). Los sujetos que hayan interrumpido su participación en SOLAR por cualquier otro motivo aparte de la confirmación de la progresión de la enfermedad en el grupo comparativo no son aptos.
    3. Cumplen con los siguientes criterios por el laboratorio central en la Selección:
    a. Aclaramiento de creatinina calculado ≥ 40 mL/min usando el aclaramiento de 24 horas de creatinina o la ecuación modificada de Cockcroft-Gault (utilizando como masa corporal ideal [IBM] en lugar de masa);
    b. Valores de aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 2,5 × LSNI; bilirrubina ≤ 1,5 × LSNI (exceptuando sujetos con síndrome de Gilbert que tengan la bilirrubina ≤ 3,0 × LSNI siguiendo la deliberación con el promotor).
    4. Las mujeres que hayan tenido el ciclo menstrual en los 2 años previos a la Selección deben dar negativo en la prueba de embarazo en suero realizada durante la selección y dar negativo en la prueba de embarazo en orina realizada el primer día de la dosis.
    5. Los sujetos potencialmente fértiles deben estar de acuerdo en utilizar métodos anticonceptivos altamente efectivos como se define en el protocolo.
    E.4Principal exclusion criteria
    1. Sézary syndrome or mycosis fungoides with B2 involvement, defined
    as a documented history of B2 and/or B2 staging at the Screening visit.
    B2 means T-cell clone in peripheral blood + one of the following at
    Screening:
    a. ≥ 1000/μL Sézary cells by direct examination OR
    b. ≥ 1000/μL CD4+ CD26- OR
    c. ≥ 1000/μL CD4+ CD7-
    2. Evidence of large cell transformation.
    3. Evidence of visceral involvement related to MF at Screening.
    4. Unresolved toxicities from prior vorinostat treatment, defined as
    having not resolved to National Cancer Institute (NCI) Common
    Terminology Criteria for Adverse Events (CTCAE, version 5.0), grade 0 or
    1.
    5. Receipt of any the following treatments:
    • Macrolide or tetracycline antibiotics within 28 days prior to Screening;
    • More than 3 short courses of prednisone equivalent > 10 mg per day
    within 8 weeks prior to Screening; however, a stable regimen of
    systemic prednisone equivalent to ≤ 10 mg per day (or steroid
    equivalent) is permitted;
    • Any CTCL systemic therapy after completion of the SOLAR study and
    prior to Day 1 for PRISM.
    6. Positive test for blood (including trace) on urinalysis. Subjects with
    non-clinically significant etiology such as menstrual blood are allowed.
    7. An active or uncontrolled infection defined as subjects who require
    systemic antibacterial, antiviral, or antifungal therapy within the last 7
    days prior to Screening.
    8. Clinically significant anemia (hemoglobin < 8 g/dL), neutropenia
    (absolute neutrophil count [ANC] < 1000/mm3) or thrombocytopenia
    (platelets < 50,000/mm3) at Screening.
    9. Presence on ECG of QT interval corrected for heart rate using
    Fridericia's formula (QTcF) > 450 msec for males or > 470 msec for
    females or > 480 msec for subjects with bundle branch block, based on a
    mean of the triplicate ECG measurements collected at Screening.
    10. Unwillingness to comply with study procedures, including follow-up,
    as specified by this protocol, or inability to communicate or cooperate
    fully with the Investigator.
    11. Lactating or pregnant.
    12. Major surgery within 4 weeks of the first dose of study treatment.
    13. Any active, clinically significant, unresolved adverse event (related
    or unrelated to study drug) from the prior study at the time of Screening.
    14. Unable to understand the purpose and risks of the study and to
    provide a signed and dated informed consent form (ICF) and
    authorization to use protected health information (in accordance with
    national and local subject privacy regulations).
    15. Clinically significant abnormalities in medical history, physical
    examination, or laboratory values that, in the opinion of the
    Investigator, would make the subject unsuitable for inclusion in the
    study.
    1. El síndrome de Sézary o micosis fungoides B2 involucrado, definido como historia documentada de B2 y estadio B2 en la visita de selección. B2 significa clon de células T en sangre periférica + uno de los siguientes en el periodo de selección:
    a. ≥ 1000/µL de células Sézary a través del examen directo;
    b. ≥ 1000/µL CD4+ CD26;
    c. ≥ 1000/µL CD4+ CD7.
    2. Evidencia de transformación de células grandes.
    3. Evidencia de implicación visceral asociada con la MF en el periodo de selección.
    4. Toxicidad no resuelta a causa de tratamiento previo con vorinostat, definida como no resuelta a grado 0 o 1 en base a los Criterios comunes de terminología para eventos adversos (CTCAE por sus siglas en inglés, versión 5.0) del Instituto Nacional del Cáncer (INC) grado 0 o 1.
    5. Estar recibiendo los siguientes tratamientos:
    • Antibióticos macrólidos o tetraciclinas dentro de los 28 días previos a lavisita de selección;
    • Más de 3 ciclos cortos de prednisona equivalentes a > 10 mg por día dentro de las 8 semanas previas a la visita de selección; sin embargo, se permite un régimen estable de prednisona sistémica equivalente a ≤ 10 mg por día (o un tratamiento esteroide equivalente);
    • Cualquier terapia sistémica de CTCL después de completar el estudio SOLAR y previo al día 1 para PRISM.
    6. Presencia de sangre (incluyendo restos) en el análisis de orina. Se permitirán sujetos con una etiología no clínica significativa, como sangrado menstrual.
    7. Una infección activa o descontrolada definida como sujetos que requieran de tratamientos sistemáticos antibacteriano, antivírico o antimicótica dentro de los 7 días previos a la visita de selección.
    8. Anemia clínicamente significativa (hemoglobina < 8 g/dL), neutropenia (recuento absoluto de neutrófilos [RAN] < 1000/mm3) o trombocitopenia (plaquetas < 50000/mm3) en la visita de selección.
    9. Presencia en el ECG del intervalo QT corregido para la frecuencia cardíaca utilizando la fórmula Fridericia (QTcF) > 450 msec para los hombres > 470 msec para las mujeres o > 480 msec para los sujetos con bloqueo de rama, basado en una media significativa de ECG recogidos por triplicado en la visita de selección.
    10. Incapacidad para completar los procedimientos del estudio, incluyendo el seguimiento, como se especifica en este protocolo o la incapacidad de comunicarse o cooperar plenamente con el Investigador.
    11. Lactancia o embarazo.
    12. Intervención quirúrgica importante dentro de las 4 semanas de la primera dosis de tratamiento del estudio.
    13. Cualquier acontecimiento adverso activo, clínicamente significativo; no resuelto (relacionado o no con el medicamento en estudio) del estudio anterior (SOLAR) en el momento de la selección.
    14. Incapacidad para comprender la finalidad y los riesgos del estudio y para proporcionar el consentimiento informado (ICF) firmado y fechado y dar autorización para usar su información de salud protegida (de acuerdo con las regulaciones nacionales y locales objeto de privacidad).
    15. Anomalías clínicamente significativas en la historia médica, exámenes físicos o valores de laboratorio que, bajo la opinión del Investigador, hacen al sujeto no apto para su participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Evaluation:
    Proportion of subjects achieving an objective response (complete response [CR] or partial response [PR]) of at least 4 months duration (ORR4) using composite global response criteria, including radiological imaging, flow cytometry, and the mSWAT scoring.
    Evaluación de eficacia primaria:
    Proporción de sujetos que alcancen una respuesta objetiva (respuesta completa [RC] o respuesta parcial [RP]) como mínimo durante 4 meses (ORR4) usando como criterio la tasa de respuesta global integrada. Esto incluye imágenes radiológicas, citometría de flujo y la puntuación de la herramienta de evaluación ponderada de severidad modificada (mSWAT por sus siglas en inglés).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Global response criteria collected 4 weeks after 4 months of sustained response (PR or CR) in the skin, and every 12 weeks thereafter.
    Criterio de respuesta global recogido 4 semanas después de 4 meses de respuesta mantenida (complete o parcial) en la piel y cada 12 semanas a partir de entonces.
    E.5.2Secondary end point(s)
    Efficacy measures:
    • Key Secondary Endpoint: Progression-free survival (PFS).
    • Change from baseline and longitudinally during the study in Pruritus Numerical Rating Scale (NRS).
    • Change from baseline and longitudinally during the study in Skindex-29 total score.
    • Change from baseline and longitudinally during the study in Skindex-29 Subdomains (Symptoms, Emotion and Functionality).
    • Change from baseline and longitudinally during the study in Pain NRS.
    • Difference in drug tolerability by Patient Impression of Treatment Side Effects
    • Duration of composite global response for responding subjects.
    • Complete response rate (CRR).
    • Time to progression (TTP).
    • Time to maximal effect in mSWAT.
    • Proportion of subjects achieving ≥ 50% improvement in mSWAT of at least 4 months duration.
    • Proportion of subjects achieving ≥ 50% improvement in mSWAT of at least 28 days in duration.
    • Percent of subjects achieving ≥ 50% improvement in mSWAT from baseline at 28 days and at 4 months.
    • Time to ≥ 50% improvement in mSWAT.
    • Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT).
    • Change in pruritus medication utilization from baseline and incidence of pruritus medication utilization.
    • Overall survival.
    • Time to next treatment

    Safety and Tolerability Evaluations:
    • Incidence and severity of clinically significant AEs (including grade 3 and 4 AEs, treatment-related AEs, SAEs, and AEs requiring discontinuation), physical examination findings, changes in electrocardiogram (ECGs), changes in laboratory parameters and changes in vital signs.

    Pharmacokinetic Evaluation:
    • Pharmacokinetic Cmax and trough concentration analysis
    Medidas de eficacia:
    • Criterio de evaluación secundario clave: Supervivencia libre de progresión (SLP).
    • Cambio desde el inicio del estudio y a lo largo del estudio en la Escala Numérica (NRS por sus siglas en inglés) del Prurito.
    • Cambio desde el inicio del estudio y a lo largo del estudioen la puntuación total de Skindex-29.
    • Cambio desde el inicio del estudio y a lo largo del estudio en los subdominios de Skindex-29 (síntomas, emoción y funcionalidad).
    • Cambios desde el inicio del estudio y a lo largo del estudio en la escala numérica (NRS) del dolor.
    • Diferencias en la tolerabilidad al medicamento según la escala de Impresión del paciente de los efectos secundarios del tratamiento
    • Duración de la respuesta integrada global de los sujetos que responden al tratamiento.
    • Tasa de respuesta completa (RC)
    • Tiempo transcurrido hasta la progresión (TTP)
    • Tiempo para efecto máximo en mSWAT.
    • Proporción de sujetos que alcanzan el ≥ 50% de mejoría en mSWAT en, al menos, 4 meses de duración.
    • Proporción de sujetos que alcanzan el ≥ 50% de mejoría en mSWAT en, al menos, 28 días en duración.
    • Proporción de los sujetos que alcanzan el ≥ 50% de mejoría mSWAT desde el inicio del estudio en 28 días y en 4 meses.
    • Tiempo para alcanzar ≥50% de mejoría en mSWAT.
    • Duración de la respuesta en la piel (tiempo sin progresión después de alcanzar ≥ 50% de mejoría en mSWAT).
    • Cambio en la utilización de medicamentos contra el prurito desde el inicio del estudio e incidencia de la utilización de medicamentos antiprurito.
    • Supervivencia global.
    • Tiempo hasta el siguiente tratamiento.

    Evaluación de seguridad y tolerancia:
    • Incidencia y severidad de acontecimientos adversos clínicamente significativos (AAS) (incluidos los grados 3 y 4 de AA, AA relacionados con el tratamiento, acontecimientos adversos graves [AAGs] y AA que requieran interrupción del tratamiento), resultados de losexámenes físicos, cambios en los electrocardiogramas (ECG), cambios en los parámetros del laboratorio y cambios en los signos vitales.

    Evaluación farmacocinética:
    • Cmax farmacocinético y análisis de concentración
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression free survival, time to progression, overall survival, complete response rate: assessed throughout study
    Pruritus & pain score, Patient Impression of Treatment Side Effects: from Day 1 until follow up visit.
    Skindex-29, mSWAT: every 4 weeks to week 81, every 8 weeks thereafter
    Safety and tolerability: assessed throughout study
    PK: Days 1, 2, 3, 5, 8, 15, 29, every 4 weeks through week 81 and every 8 weeks thereafter.
    Supervivencia libre de Progresión, tiempo hasta progresión, supervivencia general, tipo de respuesta completa: evaluada durante todo el estudio.
    Puntuación de prurito y dolor, Impresión del paciente de los efectos secundarios del tratamiento: día 1 hasta visita de seguimiento.
    Skindex-29, mSWAT: cada 4 semanas hasta semana 81, cada 8 semanas a partir de entonces.
    Seguridad y tolerabilidad: determinado durante todo el estudio.
    PK: Días 1,2,3,5,8,15,29 cada 4 semanes hasta la semana 81 y cada 8 semanas a partir de entonces.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 60
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-27
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