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    Summary
    EudraCT Number:2014-004633-96
    Sponsor's Protocol Code Number:D3461C00005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-004633-96
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3
    Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in
    Adult Subjects with Active Systemic Lupus Erythematosus
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, di fase 3, per la valutazione dell'efficacia e della sicurezza di due dosi di Anifrolumab in soggetti adulti con lupus eritematoso sistemico attivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus
    Studio per valutare l'efficacia e la sicurezza di due dosi di Anifrolumab in confronto a placebo in pazienti adulti con lupus eritematoso sistemico attivo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberD3461C00005
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorASTRAZENECA AB
    B.1.3.4CountryUnited Kingdom
    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 supportAstra Zeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstra Zeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 nameAnifrolumab
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnifrolumab
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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.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 nameAnifrolumab
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnifrolumab
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus
    Lupus eritematoso sistemico
    E.1.1.1Medical condition in easily understood language
    Lupus, an autoimmune disease
    Lupus, malattia autoimmune
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of anifrolumab 300 mg compared to placebo on disease activity as
    measured by the difference in the proportion of subjects who achieve an SLE Responder Index of ≥4 (SRI[4]) at Week 52
    Valutare l’effetto di anifrolumab 300 mg rispetto al placebo sull’attività della malattia misurata con la differenza nella percentuale di soggetti che ottengono un indice di Responder LES (SLE Responder Index, SRI) ≥4 (SRI[4]) in Settimana 52
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of anifrolumab 300mg compared to placebo on:
    a. The proportion of subjects with SRI(4) at Week 52 in the IFN testhigh
    sub-group
    b. The proportion of subjects who achieve an OCS dose ≤7.5 mg/day at
    Week 40, which is maintained through Week 52 in the sub-group of
    subjects with baseline OCS ≥10 mg/day
    c. The proportion of subjects with a ≥50% reduction in CLASI activity
    score at Week 12 in the sub-group of subjects with baseline CLASI
    activity score ≥10
    d. The proportion of subjects with SRI(4) at Week 24
    e. The annualised flare rate through 52 weeks
    2. To evaluate the effect of anifrolumab 150 mg compared to placebo on
    disease activity as
    measured by the difference in the proportion of subjects who achieve
    SRI(4) at Week 52
    3. To evaluate the safety and tolerability of anifrolumab
    1.Valutare l’effetto di anifrolumab 300 mg rispetto al placebo su:
    a.La percentuale di soggetti con SRI(4) in Settimana 52 nel sottogruppo con risultati elevati al test IFN
    b.La percentuale di soggetti che raggiunge una dose di corticosteroidi orali ≤7,5 mg/die in Settimana 40, che viene mantenuta fino alla Settimana 52 nel sottogruppo di soggetti con corticosteroidi orali al basale ≥10 mg/die
    c.La percentuale di soggetti con una riduzione ≥50% nel punteggio delCLASI, in Settimana 12 nel sottogruppo di soggetti con un punteggio dell’attività CLASI al basale ≥10
    d.La percentuale di soggetti con SRI(4) in Settimana 24
    e.il tasso di riesacerbazione annualizzato nelle 52 settimane
    2.Valutare l’effetto di anifrolumab 150 mg rispetto al placebo sull’attività della malattia misurata con la differenza nella percentuale di soggetti che raggiungono (SRI[4]) in Settimana 52
    3.Valutare la sicurezza e la tollerabilità di anifrolumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 through 70 years at the time of screening
    2. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according
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    to the ACR 1982 revised criteria ≥24 weeks prior to signing the Informed
    Consent form (ICF)
    3. Currently receiving at least 1 of the following:
    (a) A dose of oral prednisone (≤40 mg/day) for a minimum of 2 weeks
    prior to signing of the ICF.
    (b) Any of the following medications administered for a minimum of 12
    weeks prior to signing the informed consent, and at a stable dose for a
    minimum of 8 weeks prior to signing the informed consent and until Day
    1:
    (i) Azathioprine ≤200 mg/day
    (ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine)
    (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
    (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25
    mg/week
    (v) Mizoribine ≤150 mg/day
    4. Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for
    SLE, at least 1 of which must be:
    (a) Positive antinuclear antibody (ANA) test at screening by
    immunofluorescent assay (IFA) at the central laboratory with titre ≥
    1:80; OR
    (b) Elevated anti-dsDNA antibodies OR anti-Smith (anti-Sm) antibody at
    screening as determined by the central laboratory
    5. At Screening, Disease Activity Adjudication Group confirmation of:
    SLEDAI-2K Criteria: SLEDAI-2K score ≥6 points and "Clinical" SLEDAI-2K
    score ≥4 points. The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment
    score without the inclusion of points attributable to any urine or
    laboratory results including immunologic measures:
    6. Must not have active or latent TB on either chest radiograph or by
    quantiferon gold test
    7. Day 1 "Clinical" SLEDAI-2K score ≥4 points
    8. OCS dose stable for at least 2 weeks
    9. Stable SLE SOC treatment
    10. Women of child-bearing potential must have a negative serum β-hCG
    test at screening and negative urine pregnancy test prior to
    administration of investigational product
    1. Età tra i 18 e i 70 anni al momento dello screening
    2. Diagnosi di LES adulto o pediatrico con diagnosi di LES secondo i criteri ACR 1982 rivisti ≥24 settimane prima della firma del Modulo di consenso informato (ICF)
    3. Assume attualmente almeno 1 dei farmaci seguenti:
    (a) una dose di prednisone orale (≤40 mg/die) per almeno 2 settimane prima della firma del ICF
    (b) Uno dei seguenti farmaci assunti per almeno 12 settimane prima della firma del consenso informato e a una dose stabile per almeno 8 settimane prima della firma del consenso informato e fino al Giorno 1:
    (i) azatioprina ≤200 mg/die
    (ii) antimalarico (ad esempio clorochina, idrossiclorochina, quinacrina)
    (iii) micofenolato mofetile ≤2 g/die o acido micofenolico ≤1,44 g/die
    (iv) metotrexato orale, sottocutaneo (SC) o intramuscolare ≤25 mg/settimana
    (v) mizoribina ≤150 mg/die
    4. Soddisfa almeno 4 degli 11 criteri di classificazione ACR 1982 modificati per il LES, almeno 1 dei quali deve essere:
    (a) test anticorpi antinucleo (ANA) positivo allo screening con il test di immunofluorescenza (IFA) presso il laboratorio centrale con un titolo ≥1:80; OPPURE
    (b) elevati anticorpi anti-dsDNA OPPURE anticorpi anti-Smith (anti-Sm) allo screening in base alla determinazione del laboratorio centrale
    5. Allo screening, conferma dal gruppo di valutazione (Adjudication Group) dell’attività della malattia di: Criteri SLEDAI-2K: punteggio SLEDAI-2K ≥6 punti e punteggio SLEDAI-2K “clinico” ≥4 punti. Lo SLEDAI-2K “clinico” è il punteggio di valutazione dello SLEDAI-2K senza l’inclusione di punti attribuibili a risultati delle urine o di laboratorio inclusi i parametri immunologici.
    6. Non deve avere TB attiva o latente alla radiografia toracica o al Quantiferon Gold Test
    7. Giorno 1 SLEDAI-2K “clinico” ≥4 punti
    8. Dose di OCS stabile per almeno 2 settimane
    9. Trattamento SOC stabile per il LES
    10. Le donne potenzialmente fertili devono avere un test sierico β-hCG negativo allo screening e un test di gravidanza urinario negativo prima della somministrazione del prodotto sperimentale
    E.4Principal exclusion criteria
    1. Receipt of any investigational product (small molecule or biologic
    agent) within 4 weeks or 5 half-lives prior to signing of the ICF,
    whichever is greater
    2. Receipt of any of the following:
    (a) Intra-articular, intramuscular or IV glucocorticosteroids within 6
    weeks
    prior to Day 1
    3. History of, or current diagnosis of, a clinically significant non SLErelated
    vasculitis syndrome. 4. Active severe or unstable
    neuropsychiatric SLE
    5. Active severe SLE-driven renal disease
    6. Diagnosis (within 1 year of signing the ICF) of mixed connective
    tissue disease or any history of overlap syndromes of SLE or SSc.
    7. History of, or current, inflammatory joint or skin disease other than
    SLE
    8. History of any non-SLE disease that has required treatment with oral
    or parenteral corticosteroids for more than 2 weeks within the 24 weeks
    prior to enrollment
    9. Confirmed positive test for hepatitis B or hepatitis C
    10. Any severe herpes infection at any time prior to Week 0 (Day 1)
    11. Opportunistic infection requiring hospitalisation or parenteral
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    antimicrobial treatment within 3 years prior to randomization
    12. History of cancer, apart from:
    (a) Squamous or basal cell carcinoma of the skin that has been
    successfully treated
    (b) Cervical cancer in situ that has been successfully treated
    1. Assunzione di qualunque prodotto sperimentale (piccola molecola o agente biologico) durante le 4 settimane o 5 emivite prima della firma del ICF, dei due il periodo più lungo.
    2. Aver assunto uno dei seguenti farmaci:
    (a) glucocorticosteroidi intraarticolari, intramuscolari o EV durante le 6 settimane precedenti al Giorno 1
    3. Anamnesi di, o attuale diagnosi di, una sindrome di vasculite clinicamente significativa non correlata al LES.
    4. LES neuropsichiatrico attivo severo o instabile
    5. Malattia renale indotta dal LES severo attivo
    6. Diagnosi (nell’anno precedente alla firma del ICF) di malattia del tessuto connettivo misto o anamnesi di sindrome da sovrapposizione di LES o sclerosi sistemica (SSc)
    7. Anamnesi di, o attuale, patologia infiammatoria delle articolazioni o della cute diversa dal LES
    8. Anamnesi di qualunque patologia non LES che abbia richiesto il trattamento con corticosteroidi orali o parenterali per più di 2 settimane durante le 24 settimane precedenti all’arruolamento
    9. Test positivo confermato per l’epatite B o per l’epatite C
    10. Qualunque infezione erpetica grave in qualunque momento prima della Settimana 0 (Giorno 1)
    11. Infezione opportunistica che richiede il ricovero ospedaliero o trattamento antimicrobico parenterale nei 3 anni precedenti alla randomizzazione
    12. Anamnesi di cancro, esclusi:
    (a) carcinoma a cellule squamose o carcinoma basocellulare della cute trattato con successo
    (b) cancro della cervice in situ trattato con successo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in proportions of subjects
    achieving Systemic Lupus Erythematosus Responder Index SRI(4) at
    Week 52 comparing anifrolumab 300mg to placebo
    L’endpoint primario è la differenza nelle percentuali di soggetti che raggiungono lo SRI(4) in Settimana 52 confrontando anifrolumab 300 mg al placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    1a. The composite endpoint SRI4 will be the measure of this objective.
    1b. Maintained OCS reduction defined by the following criteria:
    - Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by
    Week 40 and
    - Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from
    Week 40 to Week 52 and
    - No discontinuation of investigational product or use of restricted
    medications beyond the protocol-allowed threshold before assessment
    1c. 50% reduction in CLASI activity score compared to baseline defined
    by the following criteria:
    - Achieve ≥50% reduction of CLASI activity score at Week 12 compared
    to baseline and
    - No discontinuation of investigational product or use of restricted
    medications beyond the protocol-allowed threshold before assessment
    1d. The composite endpoint SRI4 will be the measure of this objective
    1e. Annualised flare rate with flare defined as either 1 or more new
    BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the
    previous visit
    2. The composite endpoint SRI4 will be the measure of this objective
    3. The following safety data will be collected: vital signs, physical
    examination, 12-lead ECG, haematology, clinical chemistry, urinalysis, CSSRS,
    PHQ-8, modified SLEDAI Flare Index based flares, and reported
    AEs
    1a.lL'Endpoint composito SRI(4) sarà la misura di questo obiettivo
    1b.Mantenimento della riduzione dei corticosteroidi orali definito dai criteri seguenti:
    - raggiungimento di una dose di corticosteroidi orali ≤7,5 mg/die di prednisone o equivalente entro la Settimana 40 e
    - mantenimento di una dose di corticosteroidi orali ≤7,5 mg/die di prednisone o equivalente dalla Settimana 40 alla Settimana 52 e
    - nessuna sospensione del prodotto sperimentale o uso di farmaci soggetti a restrizione oltre la soglia consentita dal protocolloa prima della valutazione
    1c.50% di riduzione nel punteggio dell’attività CLASI rispetto al basale definito dai criteri seguenti:
    - raggiungimento di una riduzione ≥50% nel punteggio dell’attività CLASI in Settimana 12 rispetto al basale e
    - nessuna sospensione del prodotto sperimentale o uso di farmaci soggetti a restrizione oltre la soglia consentita dal protocolloa prima della valutazione
    1d.L'Endpoint composito SRI(4) sarà la misura di questo obiettivo
    1.e Il tasso di riesacerbazione annualizzato ove riesacerbazione viene definita come 1 o più nuove voci BILAG-2004 A oppure 2 o più nuove voci BILAG-2004 B rispetto alla visita precedente
    2.L'Endpoint composito SRI(4) sarà la misura di questo obiettivo
    3.sarannor accolti is eguenti dati sulal sicurezza:parametri vitali, esame obiettivo, elettrocardiogrammi a 12 derivazioni,(ematologia, clinica chimica, esame delle urine,C-SSRS, PHQ-8,sull’Indice di riesacerbazione SLEDAI modificato ed eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1a. - Week 52
    1b. - Week 52
    1c. - Week 12
    1d. - Week 24
    1e. - Weeks 0- 52
    2. - Week 52
    3. - Weeks 0-52
    1a. - Settimana 52
    1b. - Settimana 52
    1c. - Settimana12
    1d. - Settimana 24
    1e. - Settimane0- 52
    2. - Settimana 52
    3. - Settimane 0-52
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Argentina
    Australia
    Brazil
    Chile
    Colombia
    Germany
    Israel
    Italy
    Korea, Republic of
    New Zealand
    Peru
    Poland
    Romania
    Taiwan
    Ukraine
    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
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 338
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 131
    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)
    Subjects who participate in this study may have the option of entering
    a separate long-term extension study, if eligible.
    I pazienti che partecipano a questo studio possono avere l'opzione di partecipare ad uno studio di estensione a lungo termine separato, se elegibili
    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 Decision2015-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
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