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    Summary
    EudraCT Number:2018-002442-37
    Sponsor's Protocol Code Number:ACT15320
    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:2018-10-25
    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 number2018-002442-37
    A.3Full title of the trial
    A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma
    Estudio de fase I/II, abierto y multicéntrico para evaluar la seguridad, la eficacia preliminar y la farmacocinética (FC) de isatuximab en combinación con otros tratamientos antineoplásicos en participantes con linfoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Isatuximab-based Therapy in Participants with Lymphoma
    Estudio sobre el tratamiento con isatuximab en participantes con linfoma
    A.4.1Sponsor's protocol code numberACT15320
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1211-9010
    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 & developpement
    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 & developpement
    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 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 number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@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 nameisatuximab
    D.3.2Product code SAR650984
    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 INNisatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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.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 namecemiplimab
    D.3.2Product code REGN2810
    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 INNcemiplimab
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB179369
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lymphoma
    Linfoma
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    Linfoma
    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 10025310
    E.1.2Term Lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1
    -To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin’s lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D).
    Phase 2
    - Cohort A1 (anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] naive cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab.
    - Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab.
    Fase I:
    Caracterizar la seguridad y la tolerabilidad de isatuximab en combinación con cemiplimab en participantes con linfoma de Hodgkin clásico (LHc) recidivante y resistente, linfoma B difuso de células grandes (LBDCG) y linfoma de células T periférico (LCTP), así como confirmar la dosis recomendada para la fase II (DRF2).
    Fase II:
    1. Cohorte A1 (LHc sin tratamiento previo con anti-PD-1/PD-L1): evaluar la tasa de remisión completa (RC) de isatuximab en combinación con cemiplimab.
    2. Cohorte A2 (LHc que ha progresado tras el tratamiento con PD-1/PD-L1), B (LBDCG) y C (LCTP): evaluar la tasa de respuesta objetiva (TRO) de isatuximab en combinación con cemiplimab.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab.
    - To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in patients with cHL.
    - To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination.
    - To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination.
    -To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.
    1. Evaluar la seguridad de la DRF2 de isatuximab en combinación con cemiplimab.
    2. Evaluar la seguridad de la combinación de isatuximab con cemiplimab y radioterapia en participantes con LHc.
    3. Evaluar la inmunogenicidad de isatuximab y cemiplimab cuando se administran en combinación.
    4. Determinar el perfil farmacocinético (FC) de isatuximab y cemiplimab cuando se administran en combinación.
    5. Evaluar la eficacia general de isatuximab en combinación con cemiplimab e isatuximab en combinación con cemiplimab y radioterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants must be ≥ 12 years of age inclusive, at the time of signing the informed consent
    - Disease location amenable to tumor biopsy at baseline
    - Measurable disease
    - For Cohort A1 (classic Hodgkin's lymphoma [cHL] anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] inhibitor naïve): Histologically confirmed advanced cHL that has relapsed or progressed after at least 3 lines of systemic therapy that may include autologous hematopoietic stem cell transplant (auto-HSCT) or auto-HSCT and brentuximab vedontin (BV)
    - For Cohort A2 (cHL anti-PD-1/PD-L1inhibitor progressor): Histologically confirmed advanced cHL which has relapsed or progressed after one previous anti-PD-1/PD-L1 containing regimen as the most recent prior therapy but no more than 4 lines of previous chemotherapy including the anti-PD-1/PD-L1 containing regimen and documentation of benefit during or after the anti-PD-1/PD-L1 containing regimen within 4 months prior to initiation of investigational medicinal product (IMP)
    - For Cohort B (diffuse large B-cell lymphoma [DLBCL]):Histologically confirmed advanced DLBCL that has relapsed or progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of systemic therapy for participants who are not eligible for auto-HSCT
    - For Cohort C (peripheral T-cell lymphoma [PTCL]): Histologically confirmed advanced PTCL that has relapsed or progressed after either first-line chemotherapy and auto-HSCT as consolidation of first remission or first-line chemotherapy if participants are ineligible for auto-HSCT
    - Body weight of > 45 kg
    - Los participantes deben tener 12 años de edad o mayores de 12, en el momento de firmar el consentimiento informado.
    - Localización de la enfermedad susceptible de biopsia tumoral al inicio del estudio.
    - Enfermedad medible
    - Para la cohorte A1 (linfoma de Hodgkin clásico [LHc] proteína de muerte celular anti-programada 1 / ligando 1 [PD-1 / PD-L1] sin tratamiento previo): LHc avanzado confirmado histológicamente que ha recaído o ha progresado después de al menos 3 líneas de terapia que puede incluir trasplante autólogo de células madre hematopoyéticas (auto-HSCT) o auto-HSCT y brentuximab vedontin (BV)
    - Para la cohorte A2 (LHc que ha progresado tras el tratamiento con PD-1/PD-L1)): LHc avanzado confirmado histológicamente que ha recaído o progresado después de un régimen anterior que contenía anti-PD-1 / PD-L1 como la terapia anterior más reciente, pero no más más de 4 líneas de quimioterapia previa, incluido el régimen que contiene anti-PD-1 / PD-L1 y la documentación de beneficios durante o después del régimen que contiene anti-PD-1 / PD-L1 dentro de los 4 meses anteriores al inicio del medicamento en investigación (IMP) )
    - Para la cohorte B (linfoma difuso de células B grandes [DLBCL]): DLBCL avanzada confirmada histológicamente que ha recaído o ha progresado después de 2 líneas de terapia sistémica, incluyendo auto-HSCT o 2 líneas de terapia sistémica para participantes que no son elegibles para auto HSCT
    - Para la cohorte C (linfoma periférico de células T [PTCL]): PTCL avanzado confirmado histológicamente que ha recaído o ha progresado después de la quimioterapia de primera línea y el auto-HSCT como consolidación de la primera remisión o quimioterapia de primera línea si los participantes no son elegibles para la auto -HSCT
    - Peso corporal de más de 45 kg.
    E.4Principal exclusion criteria
    -Prior exposure to agent that blocks CD38
    - For patients with cHL (PD-1/PD-L1 naïve), DLBCL or PTCL prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1, PD-L2, CD137, CTLA-4 or LAG-3
    - Evidence of other immune related disease /conditions
    - Has received a live-virus vaccination within 28 days of planned treatment start; seasonal flu vaccines that do not contain live virus are permitted
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2
    - Poor bone marrow reserve
    - Poor organ function
    -Exposición previa al agente que bloquea CD38.
    - Para pacientes con LHc (PD-1 / PD-L1), DLBCL o PTCL antes de la exposición a cualquier agente (aprobado o en investigación) que bloquee el PD-1 / PD-L1, PD-L2, CD137, CTLA-4 o LAG-3
    - Evidencia de otras enfermedades / condiciones relacionadas con el sistema inmune
    - Ha recibido una vacuna de virus vivos dentro de los 28 días del inicio del tratamiento planeado; Se permiten las vacunas contra la gripe de temporada que no contienen virus vivos.
    - Escala del Grupo de Oncología Cooperativa del Este (ECOG) (PS) superior o igual a 2
    - Mala reserva de médula ósea.
    - Mala función de los órganos.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    1) Dose limiting toxicities (DLTs): DLTs as observed during DLT-observation period
    2) Recommended Phase 2 dose (RP2D): Dose selected for the Phase 2 portion
    Phase 2
    3) Cohort A1 (anti-PD-1/PD-L1 naive cHL): Complete Remission Rate: The proportion of participants who have a Complete Remission as a best overall response during the isatuximab + cemiplimab therapy period using the 5-point scale per the Lugano classification where 1 is No uptake, 2 is Uptake ≤ mediastinum, 3 is Uptake > mediastinum but ≤ liver, 4 is Moderately increased uptake compared to the liver and 5 is Markedly increased uptake compared to the liver and/or new lesions
    4) Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): Response Rate : The proportion of participants who have a Complete Response or Partial Response as a best overall response during isatuximab + cemiplimab therapy period using the 5-point scale per the Lugano classification where 1 is No uptake, 2 is Uptake ≤ mediastinum, 3 is Uptake > mediastinum but ≤ liver, 4 is Moderately increased uptake compared to the liver and 5 is Markedly increased uptake compared to the liver and/or new lesions
    Fase 1
    1) toxicidad limitante de dosis (TLD): TLD observados durante el período de observación de TLD
    2) Dosis recomendada de Fase 2 (DRF2): dosis seleccionada para la porción de Fase 2

    Fase 2
    1. Cohorte A1: la tasa de RC, definida como la proporción de participantes que presenten RC como la mejor respuesta general durante el periodo de tratamiento de isatuximab + cemiplimab y evaluada según la escala de 5 puntos de la clasificación de Lugano
    4) Cohorte A2 (LHc que ha progresado tras el tratamiento con PD-1/PD-L1), B (LBDCG) y C (LCTP): Tasa de respuesta: la proporción de participantes que presentan RC o remisión parcial (RP) como mejor respuesta global durante el periodo de tratamiento de isatuximab + cemiplimab y evaluada según la escala de 5 puntos de la clasificación de Lugano
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) and 2) 1st Cycle - 28 days
    3) and 4) Up to 24 weeks after last patient treated in a given cohort
    1) y 2) 1er Ciclo - 28 días
    3) y 4) Hasta 24 semanas después del último paciente tratado en una cohorte determinada
    E.5.2Secondary end point(s)
    1) Adverse Events (AEs)/Serious Adverse Events (SAEs) for isatuximab + cemiplimab: Number of patients with AEs/SAEs
    2) Adverse Events/Serious Adverse Events for isatuximab + cemiplimab + radiotherapy: Number of patients with AEs/SAEs in cohorts A1 and A2
    3) Immunogenicity: Anti-drug antibody (ADA) levels against isatuximab and against cemiplimab
    4) Pharmacokinetic evaluation: Pharmacokinetic evaluation using non-compartmental analysis for both compounds using serum concentrations for cemiplimab and plasma concentrations for isatuximab
    5) Tumor burden change: The best percent-change from baseline
    6) Disease control rate: The sum of complete responses (CR) + partial responses (PR) + stable disease (SD)
    7) Duration of response: The time from the date of the first response (PR or CR in radiographic objective response) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever occurs first.
    8) Progression free survival: The time from the first study treatment administration to the date of first documentation of progressive disease or death, whichever comes first.
    1) Acontecimientos adversos (AA) / Acontecimientos adversos graves (AAG) para isatuximab + cemiplimab: Número de pacientes con AA / AAG
    2) Acontecimientos adversos (AA) / Acontecimientos adversos graves (AAG) para isatuximab + cemiplimab + radioterapia: Número de pacientes con AA / AAG en las cohortes A1 y A2
    3) Inmunogenicidad: niveles de anticuerpos antifármaco (AAF) contra isatuximab y contra cemiplimab
    4) Evaluación farmacocinética: evaluación farmacocinética mediante el análisis no compartimental de ambos compuestos utilizando concentraciones séricas de cemiplimab y concentraciones plasmáticas de isatuximab
    5) Cambio en la carga tumoral: el mejor cambio porcentual desde el inicio
    6) Tasa de control de la enfermedad: la suma de las respuestas completas (RC) + respuestas parciales (RP) + enfermedad estable (EE)
    7) Duración de la respuesta: el tiempo desde la fecha de la primera respuesta (RP o RC en la respuesta objetiva radiográfica) que se confirma posteriormente hasta la fecha de la primera progresión o muerte confirmada de la enfermedad, lo que ocurra primero.
    8) Supervivencia libre de progresión: el tiempo desde la administración del primer tratamiento de estudio hasta la fecha de la primera documentación de enfermedad progresiva o muerte, lo que ocurra primero.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) to 4) Up to 90 days after last study treatment administration (Up to approximately 27 months after first study treatment administration)
    5) to 8) Up to 24 weeks after last patient treated in a given cohort
    1) a 4) Hasta 90 días después de la administración del tratamiento del último estudio (hasta aproximadamente 27 meses después de la administración del primer tratamiento del estudio)
    5) a 8) Hasta 24 semanas después del último paciente tratado en una cohorte determinada
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    France
    Italy
    Korea, Republic of
    Netherlands
    Portugal
    Spain
    Taiwan
    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
    Última visita del último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 15
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 88
    F.4.2.2In the whole clinical trial 145
    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 Decision2019-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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