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    Summary
    EudraCT Number:2018-000075-33
    Sponsor's Protocol Code Number:OMS721-IGA-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000075-33
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN)
    Studio di fase III, randomizzato, in doppio cieco, controllato con placebo, sulla sicurezza e l’efficacia di OMS721 in pazienti con nefropatia da immunoglobulina A (IgA) (ARTEMIS-IGAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)
    OMS721 in pazienti con nefropatia IgA (ARTEMIS-IGAN)
    A.3.2Name or abbreviated title of the trial where available
    ARTEMIS-IGAN
    ARTEMIS-IGAN
    A.4.1Sponsor's protocol code numberOMS721-IGA-001
    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 SponsorOMEROS CORPORATION
    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 supportOmeros Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health LLC
    B.5.2Functional name of contact pointProject Management - Anita Burrough
    B.5.3 Address:
    B.5.3.1Street Address1030 Sync Street
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019197497949
    B.5.5Fax number0019197497949
    B.5.6E-mailanita.burroughs@syneoshealth.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/3/18/1984
    D.3 Description of the IMP
    D.3.1Product nameOMS721
    D.3.2Product code [OMS721]
    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 INNOMS721
    D.3.9.2Current sponsor codeOMS721
    D.3.9.4EV Substance CodeSUB190278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgA nephropathy (IgAN)
    Nefropatia IgA (IgAN)
    E.1.1.1Medical condition in easily understood language
    Nephritis caused by deposition of antibodies in the kidneys
    Nefrite causata dalla deposizione di anticorpi nei reni
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of OMS721 in patients with IgA nephropathy (IgAN) on proteinuria assessed by 24-hour urine protein excretion (UPE) in g/day at 36 weeks from baseline
    Valutare l’effetto di OMS721 sulla proteinuria in pazienti con nefropatia da IgA (IgAN) mediante l’escrezione di proteine urinarie delle 24 ore (UPE, urine protein excretion) misurata in g/giorno a 36 settimane dal basale.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of OMS721 in patients with IgAN on:
    • Proteinuria assessed by 24-hour UPE at 36 weeks from baseline in the
    subset of patients with high baseline proteinuria (defined as 24-hour
    UPE = 2 g)
    • Durability of proteinuria response from 36 weeks
    • Renal function as determined by the rate of change in estimated
    glomerular filtration rate (eGFR) up to 144 weeks from baseline
    • Safety and tolerability
    • Pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity
    of OMS721
    Valutare l’effetto di OMS721 in pazienti con IgAN per quanto riguarda:
    - Proteinuria valutata mediante l’UPE delle 24 ore a 36 settimane dal basale nel sottoinsieme di
    pazienti con proteinuria elevata al basale (definita come UPE delle 24 ore = 2 g/giorno)
    - Durata della risposta alla proteinuria a 36 settimane
    - Funzionalità renale determinata mediante il tasso di variazione della velocità di filtrazione
    glomerulare stimata (eGFR o VFG stimata) fino a 144 settimane dal basale
    - Sicurezza e tollerabilità
    - Farmacocinetica (PK), farmacodinamica (PD) e immunogenicità di OMS721
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older at the onset of Screening
    2. Understand and voluntarily sign an informed consent form in
    accordance with regulations and governing institutional review board
    (IRB) or independent ethics committee (IEC) requirements prior to any
    procedures or evaluations performed specifically for the sole purpose of
    the study
    3. Biopsy-confirmed diagnosis of IgAN within 8 years prior to Screening
    4. Documented history of proteinuria > 1 g/day within 6 months prior to
    Screening or uPCR > 0.75 by spot urine at Screening
    5. Mean of two proteinuria measurements > 1 g/day at baseline
    6. Estimated glomerular filtration rate of = 30 mL/min/1.73 m2
    calculated according to the Chronic Kidney Disease Epidemiology
    Collaboration (CKD-EPI) equation [Levey 2009] at Screening and
    baseline
    7. Females having heterosexual intercourse should either a) not be of
    childbearing potential (i.e., surgically sterilized or postmenopausal for >1 year), b) have a negative pregnancy test at Screening and baseline
    and, if sexually active, must agree to use two medically reliable forms of
    contraception throughout the study and for at least 12 week after the
    last dose of study drug, including possible retreatments, or c) have a
    medically sterilized male partner. Acceptable methods of contraception
    include a reliable intrauterine device, hormonal contraception, or a
    barrier method.
    8. Males having heterosexual intercourse should either a) not be of
    reproductive potential or b) if sexually active, must agree to use a
    medically reliable form of contraception throughout the study and for at
    least 12 weeks after the last dose of study drug, including possible
    retreatments. Acceptable methods of birth control include spermicide in
    combination with a barrier method, or patient's female partner is willing
    to use medically acceptable methods of birth control (i.e., intrauterine
    device, hormonal contraception, or a barrier method).
    9. Male patients must be willing to avoid fathering children for at least
    12 weeks following the last dose of study medication.
    - Età = 18 anni all’inizio del periodo di screening
    - Diagnosi di IgAN confermata da biopsia risalente a massimo 8 anni precedenti allo screening
    - Storia documentata di proteinuria > 1 g/giorno entro 6 mesi dallo screening o uPCR > 0,75 in spot
    urinario allo screening
    - Media di due misurazioni della proteinuria > 1 g/giorno al basale
    - Velocità di filtrazione glomerulare stimata = 30 mL/min/1,73 m2 allo screening e al basale
    7. Le donne che hanno un rapporto eterosessuale non dovrebbero essere a) potenzialmente fertili (vale a dire, chirurgicamente sterilizzato o in postmenopausa per> 1 anno), b) avere un test di gravidanza negativo allo Screening e al basale
    e, se sessualmente attive, devono accettare di utilizzare due forme di efficacia medica di contraccezione durante lo studio e per almeno 12 settimane dopo l'ultima dose di farmaco in studio, inclusi i possibili trattamenti, o c) avere un partner maschile sterilizzato dal punto di vista medico. Metodi contraccettivi accettabili includeno un dispositivo intrauterino affidabile, contraccettivi ormonali o un metodo di barriera.
    8. I maschi che hanno rapporti eterosessuali non dovrebbero essere a) potenziali riproduttori o b) se sessualmente attivi, devono accettare di usare una forma di contraccezione medicalmente affidabile per tutto lo studio e per almeno 12 settimane dopo l'ultima dose di farmaco in studio, incluso i possibili ritrattamenti. I metodi accettabili di controllo delle nascite comprendono lo spermicida in combinazione con un metodo di barriera, o la partner femminile del paziente che sia disponibile ad
    usare metodi di controllo delle nascite accettabili dal punto di vista medico (cioè, dispositivo intrauterino, contraccezione ormonale o metodo di barriera).
    9. I pazienti di sesso maschile devono essere disposti ad evitare di generare figli almeno 12 settimane dopo l'ultima dose di farmaco in studio.
    E.4Principal exclusion criteria
    1. Treatment with immunosuppressants (e.g., azathioprine or
    cyclophosphamide), or cytotoxic drugs, for IgAN within 8 weeks prior to
    Screening. Treatment with immunosuppressants or cytotoxic drugs for
    IgAN is not allowed during the Run-In Period. Treatment with
    immunosuppressants are allowed if such treatment is for indications
    other than IgAN.
    2. Treatment with eculizumab within 8 weeks prior to Screening.
    Treatment with eculizumab is not allowed during the Run-In Period.
    3. Treatment with systemic corticosteroids within 8 weeks prior to
    Screening. Treatment with systemic corticosteroids is not allowed during
    the Run-In Period.
    4. Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of >
    100 mmHg at rest despite the combination of two or more antihypertensives
    including ACEIs, ARBs, or direct renin inhibitors at
    Screening and baseline
    5. Female patients who are pregnant, breast feeding, or planning to
    become pregnant until 12 weeks after the last dose of study drug,
    including possible retreatments
    6. Clinical or biological evidence of Type 1 diabetes mellitus (DM) or
    poorly controlled DM with hemoglobin A1c > 7.5 or with evidence of
    diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA
    vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal
    disease during Screening and Run-In
    7. Presence of significant morbidity or other major illness or disease that
    may confound the interpretation of the clinical trial results or may result
    in death within 2 years of Screening
    8. History of renal transplantation
    9. Have a known hypersensitivity to any constituent of the
    investigational product
    10. Rapidly progressive glomerulonephritis, defined as a fall in eGFR of >
    30 mL/min/1.73 m2 within 24 weeks or > 15 mL/min/1.73 m2 within
    12 weeks of Screening. During the Run-In period a patient will be
    excluded if they experience a decrease in eGFR of > 15 mL/min/1.73 m2
    from their best eGFR from the beginning of Screening.
    11. Significant abnormalities in clinical laboratory values including any
    of the following at the time of evaluation during Screening and Run-In:
    a. hemoglobin < 9.0 g/dL
    b. platelet count < 100,000 cells/mm3
    c. absolute neutrophil count < 500 cells/mm3
    d. alanine transaminase or aspartate transaminase (AST) > 3.0 × the upper limit of normal (ULN)
    e. serum bilirubin > 2 × ULN
    12. History of HIV, evidence of immune suppression, active HCV infection
    (patients with positive anti-HCV antibody but a non-detected HCV RNA
    PCR can enroll), HBV infection (patients with positive HBsAg are
    excluded. For patients with isolated positive anti-HBc antibody, HBV DNA
    test by PCR must be non-detectable to enroll).
    13. Diagnosis of a malignancy except for adequately treated and cured
    basal or squamous cell skin cancer, curatively treated in situ disease, or
    other cancer from which the patient has been disease-free for = 5 years
    14. Have received any other investigational drug or device or
    experimental procedures within 30 days of the Screening Visit or within
    5 times the plasma half-life of the administered experimental drug,
    whichever is longer
    15. Previously received OMS721
    16. Is an employee of Omeros, the investigative site (whereas site is
    meant as the clinic, department, or Clinical Research Unit in which the
    Investigator works or conducts the trial), a study staff member, or their
    immediate family member
    17. Presence of any condition that the Investigator believes would put
    the patient at risk from participation
    18. Any patient who, in the opinion of the Investigator, is likely to be
    noncompliant or who is not suitable for the study
    19. Presence of active infection occurring within 7 days of Screening or
    at the time of Screening
    - Trattamento con immunosoppressori (per esempio, azatiopirina o ciclofosfamide), farmaci
    citotossici o eculizumab nelle 8 settimane precedenti allo screening, a meno che tale trattamento
    venga somministrato per patologie diverse da IgAN
    - Trattamento con corticosteroidi sistemici entro 8 settimane dallo screening
    - PA non controllata, PA sistolica > 150 mmHg e diastolica > 100 mmHg a riposo nonostante la
    combinazione di due o più farmaci anti-ipertensivi, inclusi inibitori ACE, ARB o inibitori diretti
    della renina
    - Stato di gravidanza, allattamento o gravidanza prevista nel periodo dello studio fino alla
    12 settimana dopo l’ultima dose di farmaco dello studio, compresi eventuali ritrattamenti
    - Evidenze cliniche o biologiche di diabete mellito di tipo 1 (DM) o DM mal controllato con
    emoglobina A1c > 7,5 o evidenza di nefropatia diabetica tramite biopsia, lupus eritematoso
    sistemico, vasculite da IgA (porpora di Schönlein-Henoch), IgAN secondaria o altra malattia
    renale durante lo screening o il periodo di run-in
    - Presenza di malattie significative o rilevanti di altro tipo che possono confondere l’interpretazione
    dei risultati della sperimentazione clinica o possono provocare la morte entro 2 anni dallo
    screening.
    - Storia clinica di trapianto renale
    - Ipersensibilità nota a qualunque componente del prodotto sperimentale
    - Glomerulonefrite a progressione rapida, definita come una riduzione dell’eGFR
    > 30 mL/min/1,73 m2 nelle 24 settimane precedenti lo screening o > 15 mL/min/1,73 m2 nelle
    12 settimane precedenti lo screening.
    - Anomalie significative nei risultati degli esami clinici di laboratorio
    - Storia clinica di virus dell’immunodeficienza umana (HIV), evidenza di immunosoppressione,
    infezione da virus dell’epatite C (HCV) attiva (sono arruolabili i pazienti con anticorpi anti-HCV
    con RNA di HCV non rilevato da test PCR), infezione da virus dell’epatite B (HBV) (sono esclusi
    i pazienti con HbsAg positivo. Sono arruolabili i pazienti positivi per anticorpo anti-HBc isolato e
    DNA di HBV non rilevabile da test PCR).
    - Diagnosi di neoplasia eccettuati i tumori a cellule basali o squamose dell’epidermide
    adeguatamente trattati e curati, neoplasie in situ trattate e curate o altri tipi di neoplasia da cui il
    paziente risulti curato da almeno 5 anni
    - Trattamento con qualunque altro farmaco o dispositivo sperimentale oppure con procedure
    sperimentali nei 30 giorni precedenti la visita di screening (VS) o entro 5 volte la durata
    dell’emivita plasmatica del farmaco sperimentale somministrato, a seconda dei quali dei due
    periodi è più lungo
    15. OMS721 precedentemente ricevuto
    16. È un dipendente di Omeros, il centro sperimentale (considerando che, il centro è inteso come la clinica, dipartimento o unità di ricerca clinica in cui lo sperimentatore lavora o conduce lo studio), un membro dello staff di studio o il loro
    componente della famiglia
    17. Presenza di qualsiasi condizione che l'Investigator ritiene possa porre il paziente a rischio di partecipazione
    18. Qualsiasi paziente che, secondo il parere dello sperimentatore, è probabile che sia non conforme o che non è adatto allo studio
    19. Presenza di infezione attiva che si verifica entro 7 giorni dallo screening o al momento dello Screening
    E.5 End points
    E.5.1Primary end point(s)
    • The primary endpoint of this study is the change from baseline in logtransformed
    24-hour UPE in g/day at 36 weeks from baseline
    - L’endpoint primario di questo studio è la variazione trasformata logaritmica rispetto al basale,
    dell’UPE delle 24 ore in g/giorno a 36 settimane dal basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 weeks
    36 settimane
    E.5.2Secondary end point(s)
    • Proteinuria responder, defined as having a 24-hour UPE of at least
    50% reduction from baseline as assessed at Week 36 (patients with = 2
    g/day UPE at baseline only)
    • The rate of change in eGFR up to 144 weeks from baseline
    Other Secondary Endpoints
    • Time-averaged change from baseline in the log-transformed 24-hour
    UPE between 36 weeks and 48 weeks
    • Time-averaged change from baseline in the log-transformed 24-hour
    UPE between 36 weeks and 72 weeks
    • Time-averaged 24-hour UPE from 36 weeks to 48 weeks to a level at
    least 50% reduced from the baseline 24-hour UPE (patients with = 2
    g/day UPE at baseline only)
    • Time-averaged 24-hour UPE from 36 weeks to 72 weeks to a level at
    least 50% reduced from the baseline 24-hour UPE (patients with = 2
    g/day UPE at baseline only)
    - Risposta del paziente, ossia una riduzione dell’UPE delle 24 ore di almeno 50% rispetto al
    basale alla settimana 36 (solo pazienti con UPE = 2 g/giorno al basale)
    - Tasso di variazione dell’eGFR fino a 144 settimane dal basale
    - Variazione media nel tempo trasformata logaritmica rispetto al basale dell’UPE delle 24 ore
    nell’arco di 36-48 settimane
    - Variazione media nel tempo trasformata logaritmica rispetto al basale dell’UPE delle 24 ore
    nell’arco di 36-72 settimane
    - Media dell’UPE a 24 ore nel tempo con riduzione di almeno 50% rispetto all’UPE delle 24 ore al
    basale nell’arco di 36-48 settimane (solo pazienti con UPE = 2 g/giorno al basale)
    - Media dell’UPE a 24 ore nel tempo con riduzione di almeno 50% rispetto all’UPE delle 24 ore al
    basale nell’arco di 36-72 settimane (solo pazienti con UPE = 2 g/giorno al basale)
    E.5.2.1Timepoint(s) of evaluation of this end point
    36, 48, and 72 weeks for UPE, and 144 week for the rate of change in eGFR.
    36, 48 e 72 settimane per UPE e 144 settimane per il tasso di variazione in eGFR.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 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 EEA42
    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 Information not present in EudraCT
    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
    Canada
    Korea, Democratic People's Republic of
    Malaysia
    Philippines
    Singapore
    Taiwan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 410
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 450
    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)
    Applicable local standard of care
    Cura locale standard applicabile
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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