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    Summary
    EudraCT Number:2017-004865-28
    Sponsor's Protocol Code Number:CLAG525B2101
    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:2018-09-25
    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 number2017-004865-28
    A.3Full title of the trial
    A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer
    Estudio de fase II, multicéntrico, aleatorizado, abierto, de tres grupos, de LAG525 administrado en combinación con spartalizumab (PDR001), o con spartalizumab y carboplatino, o con carboplatino, como primera o segunda línea de tratamiento en pacientes con cáncer de mama triple negativo avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of efficacy and safety of LAG525 in combination with spartalizumab, or with spartalizumab and carboplatin, or with carboplatin, in patients with advanced triple-negative breast cancer.
    Estudio de la eficacia y seguridad de LAG525 en combinación con spartalizumab, o con spartalizumab y carboplatino, o con carboplatino, en pacientes con cáncer de mama triple negativo avanzado.
    A.4.1Sponsor's protocol code numberCLAG525B2101
    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 SponsorNovartis Farmacéutica, S.A
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJavier Malpesa
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493306 44 64
    B.5.6E-maileecc.novartis@novartis.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 LAG525
    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 INNnot established
    D.3.9.2Current sponsor codeLAG525
    D.3.9.3Other descriptive nameLAG525
    D.3.9.4EV Substance CodeSUB177020
    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.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 namespartalizumab
    D.3.2Product code PDR001
    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 INNSPARTALIZUMAB
    D.3.9.2Current sponsor codePDR001
    D.3.9.4EV Substance CodeSUB191185
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 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 Yes
    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 namecarboplatin
    D.3.4Pharmaceutical form 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 INNCARBOPLATIN
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Triple negative breast cancer
    Cáncer de mama triple negativo.
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Cáncer de mama
    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 LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the antitumor activity of the three treatment arms LAG525 + spartalizumab, LAG525 + spartalizumab + carboplatin and LAG525 + carboplatin, in subjects with advanced TNBC in first
    or second line therapy, as measured by the objective response rate (ORR) per investigator’s
    assessment according to RECIST v1.1
    Evaluar la actividad antitumoral de los tres grupos de tratamiento LAG525 + spartalizumab, LAG525 + spartalizumab + carboplatino y LAG525 + carboplatino en sujetos con CMTN avanzado en primera o segunda línea de tratamiento, según la tasa de respuesta objetiva (ORR) conforme a la evaluación del investigador según RECIST v1.1.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of the three treatment arms with respect to DOR per investigator’s assessment according to RECIST v1.1
    - To assess Overall Survival for each treatment arm
    - To characterize the PK parameter, Ctrough, of LAG525, spartalizumab, and carboplatin in the three investigated combinations
    - To assess the efficacy of the three treatment arms with respect to TTR per investigator’s assessment according to RECIST v1.1
    - To assess the efficacy of the three treatment arms with respect to PFS per investigator’s assessment according to RECIST v1.1
    - To assess the efficacy of the three treatment arms with respect to CBR per investigator’s assessment according to RECIST v1.1
    - To characterize the PK parameter, Cmax, of LAG525,
    spartalizumab, and carboplatin in the three investigated combinations
    - To assess immunogenicity of LAG525 and spartalizumab in the three investigated combinations
    -Evaluar la eficacia de los tres grupos de tratamiento respecto a la duración de respuesta (DOR), tiempo hasta la respuesta (TR), supervivencia libre de progresión (PFS) y tasa de beneficio clínico (TBC) conforme a la evaluación del
    investigador según RECIST v1.1.
    - Evaluar la supervivencia global en cada grupo de tratamiento.
    - Caracterizar el perfil de seguridad de cada grupo de tratamiento.
    - Caracterizar la farmacocinética (PK) de LAG525, spartalizumab y carboplatino en las tres combinaciones investigadas.
    - Evaluar la inmunogenicidad de LAG525 y spartalizumab en las tres
    combinaciones investigadas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient has advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
    • Patient must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other loco-regional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented)
    • Patient progressed after adjuvant or 1 prior systemic treatment in the metastatic setting. Patients with de novo metastatic disease are eligible if they received 1 prior line of therapy
    • Patient must have received prior systemic treatment that included taxane-based chemotherapy for adjuvant or metastatic disease
    • Patient must have a site of disease amenable to biopsy, and must be willing to undergo a new tumor biopsy at screening and during therapy on this study, the latter if medically feasible. Patients with an available archival tumor tissue do not need to perform a tumor biopsy at screening if patient has not received anti-cancer therapy since the biopsy was taken.
    • Patient has histologically and/or cytologically confirmed diagnosis of TNBC (based on most recently analyzed biopsy, local lab) meeting the following criteria: HER2 negative in situ hybridization test or an IHC status of 0 or 1+, and ER and PR expression is <1 percent as determined by immunohistochemistry (IHC)

    Other protocol-defined inclusion criteria may apply
    -Pacientes con cáncer de mama avanzado (locorregionalmente recurrente no susceptible de recibir tratamiento curativo o metastásico).
    -Pacientes con enfermedad medible, es decir, al menos una lesión medible según los criterios RECIST v1.1 (las lesiones tumorales previamente irradiadas o sometidas a otro tratamiento locorregional solo se considerarán medibles si la progresión de la enfermedad en el lugar tratado después de la finalización del tratamiento está claramente documentada).
    -Pacientes que hayan progresado tras el tratamiento adyuvante o tras una línea previa de tratamiento sistémico para la enfermedad metastásica. Los pacientes con enfermedad metastásica de novo son elegibles si han recibido una línea previa de tratamiento.
    -Pacientes que hayan recibido tratamiento sistémico previo que incluyera quimioterapia basada en taxanos para la enfermedad adyuvante o metastásica.
    -Pacientes con una zona de enfermedad en la que pueda realizarse una biopsia y dispuestos a que se les realice una nueva biopsia del tumor en la selección y durante el tratamiento de este estudio, este último si es médicamente factible. Los pacientes con un tejido tumoral archivado disponible no deben someterse a una biopsia tumoral en la selección si no han recibido tratamiento contra el cáncer desde que se realizó la biopsia.
    -Pacientes con diagnóstico histológica o citológicamente confirmado de CMTN (basado en la biopsia analizada más recientemente, laboratorio local) que cumpla los siguientes criterios: HER2 negativo en la prueba de hibridación in situ o un estado 0 o 1+ de IHQ, y expresión de ER y PR < 1 % según la determinación mediante inmunohistoquímica (IHQ).
    Se pueden aplicar otros criterios de inclusión definidos por el protocolo.
    E.4Principal exclusion criteria
    • Patient has received prior treatment with anti-LAG-3, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (any line of therapy).
    • Patient received prior therapy with a platinum agent or mitomycin and experienced recurrence within 12 months after the end of the platinum-based or mitomycin containing therapy
    • Patient has had major surgery within 14 days prior to starting study treatment or has not recovered to grade 1 or less from major side effects.
    • Patient with presence of CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are
    excluded if ≥ CTCAE grade 3) due to prior cancer therapy.
    • Patient has received radiotherapy ≤ 4 weeks prior to randomization (≤ 2 weeks for limited field radiation for palliation), and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
    • Patient has a known hypersensitivity to other monoclonal antibodies, platinumcontaining compounds, or to any of the excipients of LAG525, spartalizumab, or carboplatin.
    • Patient with history or presence of central nervous system (CNS) metastases, treated or untreated.

    Other protocol-defined exclusion criteria may apply
    -Pacientes que hayan recibido tratamiento previo con anticuerpos anti-LAG-3, anti-PD-1, anti-PD-L1 o anti-PD-L2 (cualquier línea de tratamiento).
    -Pacientes que hayan recibido tratamiento previo con un fármaco basado en platino o mitomicina y que hayan experimentado recurrencia durante los 12 meses posteriores al final del tratamiento basado en platino o que contiene mitomicina.
    -Pacientes que hayan sido sometidos a cirugía mayor durante los 14 días anteriores al inicio del tratamiento del estudio o cuyos efectos secundarios mayores no se hayan resuelto a grado 1 o inferior.
    -Pacientes con toxicidad de grado ≥ 2 de los CTCAE (excepto alopecia, neuropatía periférica y ototoxicidad, que se excluyen en caso de grado ≥ 3 de los CTCAE) debido a un tratamiento previo contra el cáncer.
    -Pacientes que hayan recibido radioterapia ≤ 4 semanas antes de la aleatorización (≤ 2 semanas en caso de radioterapia paliativa de campo limitado) y los efectos secundarios relacionados con dicho tratamiento no se hayan resuelto a grado 1 o inferior (salvo alopecia).
    -Pacientes con hipersensibilidad conocida a otros anticuerpos monoclonales, compuestos que contengan platino o cualquiera de los excipientes de LAG525, spartalizumab o carboplatino.
    -Pacientes con antecedentes o presencia de metástasis en el sistema nervioso central (SNC), tratadas o no tratadas.
    Se pueden aplicar otros criterios de exclusión definidos por el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) per RECIST v1.1 per investigators'assessment
    Tasa de respuesta objetiva (ORR) conforme a la evaluación del investigador según RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks for the first 6 months and every 12 weeks thereafter
    Cada 6 semanas durante los primeros 6 meses y cada 12 semanas a partir de entonces
    E.5.2Secondary end point(s)
    1) Duration of response (DOR)
    2) Overall Survival (OS)
    3) Pharmacokinetics (PK) parameter, Ctrough, of
    LAG525, spartalizumab and carboplatin
    4) Time to response (TTR)
    5) Progression free survival (PFS)
    6) Clinical Benefit Rate (CBR)
    7) PK parameter, Cmax of LAG525, spartalizumab and
    carboplatin
    8) Anti-drug antibodies (ADA) prevalence at baseline
    and ADA incidence on-treatment for LAG525 and
    spartalizumab
    1) Duración de respuesta (DOR)
    2) Superviviencia global (SG)
    3) Parámetro de farmacocinética (PK), Ctrough, de
    LAG525, spartalizumab y carboplatino
    4) Duración de respuesta (DOR)
    5) Supervivencia libre de progresión (PFS)
    6) Tasa de beneficio clínico (TBC)
    7)Parámetro PK, Cmax de LAG525, spartalizumab y
    carboplatino
    8)Prevalencia de anticuerpos antidroga (ADA) al inicio del estudio
    y la incidencia de ADA en el tratamiento para LAG525 y
    spartalizuma
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Every 6 weeks for the first 6 months and every 12 weeks thereafter
    1) Every 12 weeks until death, lost to follow-up, or withdrawal of consent
    2) From cycle 1 to cycle 7 and at EOT with more timepoints at C1 and C3
    3, 4 & 5) Every 6 weeks for the first 6 months and every 12 weeks thereafter
    6) From cycle 1 to cycle 7 and at EOT with more timepoints at C1 and C3
    7) At Day 1 of each cycle until cycle 7 and at EOT
    - Cada 6 semanas durante los primeros 6 meses y cada 12 semanas a partir de entonces
    1) Cada 12 semanas hasta la muerte, pérdida durante el seguimiento o retiro del consentimiento.
    2) Del ciclo 1 al ciclo 7 y en el final de ensayo con más momentos de evaluación en C1 y C3
    3, 4 y 5) Cada 6 semanas durante los primeros 6 meses y cada 12 semanas a partir de entonces
    6) Del ciclo 1 al ciclo 7 y en el final de ensayo con más momentos de evaluación en C1 y C3
    7) En el día 1 de cada ciclo hasta el ciclo 7 y en EOT
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Canada
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Lebanon
    Singapore
    Spain
    Taiwan
    Thailand
    United Kingdom
    United States
    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
    Study completion is defined as when the last subject finishes their Study Completion visit, and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator, or in the event of an early study termination decision, the date of that decision.
    La finalización del estudio se define como se realiza la última visita del último paciente, y alguna otra evaluación asociada con esta visita la cual el investigador ha documentado y ha seguido apropiadamente, o en el caso de una decisión de terminación anticipada del estudio, la fecha de tal decisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years2
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 96
    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)
    At the end of the study, every effort will be made to continue provision of study treatment outside this study through an alternative setting to patients who in the opinion of the Investigator are still deriving clinical benefit
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-25
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