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    Summary
    EudraCT Number:2018-000840-24
    Sponsor's Protocol Code Number:CQGE031C2303
    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:2021-02-02
    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 number2018-000840-24
    A.3Full title of the trial
    A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo e farmaco attivo per valutare l’efficacia e la sicurezza di ligelizumab (QGE031) nel trattamento dell’Orticaria Cronica Spontanea (CSU) in adolescenti e adulti inadeguatamente controllati con H1- antistaminici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III study of efficacy and safety of ligelizumab in the treatment of Chronic Spontaneous Urticaria in adolescents and adults inadequately controlled with H1-antihistamines
    Studio di fase III per valutare l’efficacia e la sicurezza di ligelizumab (QGE031) nel trattamento dell’Orticaria Cronica Spontanea (CSU) in adolescenti e adulti inadeguatamente controllati con H1- antistaminici
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCQGE031C2303
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    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 SponsorNOVARTIS PHARMA AG
    B.1.3.4CountrySwitzerland
    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 organisationNovartis Farma SpA
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio (VA)
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390296541
    B.5.5Fax number0039029659066
    B.5.6E-mailinfo.studiclinici@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.3.1Product nameLigelizumab
    D.3.2Product code [QGE031]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIGELIZUMAB
    D.3.9.2Current sponsor codeQGE031
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB177843
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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.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 nameLigelizumab
    D.3.2Product code [QGE031]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIGELIZUMAB
    D.3.9.2Current sponsor codeQGE031
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB177843
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Xolair
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameomalizumab
    D.3.2Product code [IGE025]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOMALIZUMAB
    D.3.9.1CAS number 242138-07-4
    D.3.9.2Current sponsor codeIGE025
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Spontaneous Urticaria
    Orticaria Cronica Spontanea
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    Orticaria
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10046735
    E.1.2Term Urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    The primary objective of the study is to demonstrate that ligelizumab is superior to placebo and superior to omalizumab 300 mg q4w in change from baseline in UAS7 at Week 12
    L’obiettivo primario dello studio è quello di dimostrare la superiorità di ligelizumab rispetto a placebo e a omalizumab 300mg q4w in termini di cambiamento rispetto al basale dell’UAS7 a 12 settimane
    E.2.2Secondary objectives of the trial
    To demonstrate that a greater proportion of subjects achieve UAS7=0 at Week 12 who are treated with ligelizumab 72 mg q4w and/or 120 mg q4w compared to placebo-treated subjects and compared with omalizumab 300 mg q4w treated subjects

    To demonstrate the superiority of ligelizumab 72 mg q4w and/or 120 mg q4w treated subjects with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated subjects and omalizumab 300 mg q4w treated subjects

    To demonstrate that a greater proportion of subjects who are treated with ligelizumab q4w achieve DLQI= 0-1 at Week 12 compared to placebo-treated subjects and omalizumab 300 mg q4w treated subjects

    To demonstrate that the ligelizumab 72 mg q4w and/or 120 mg q4w treated subjects have a longer angioedema occurrence-free period compared with placebo-treated subjects and omalizumab 300 mg q4w treated subjects.

    To demonstrate the safety and tolerability of ligelizumab 72 mg q4w and 120 mg q4w
    Obiettivo 1: dimostrare che una proporzione maggiore di pazienti raggiungono un UAS7=0 quando trattati con ligelizumab 72mg q4w e/o 120mg q4w rispetto a placebo e rispetto a omalizumab 300mg q4w
    Obiettivo2: dimostrare la superiorità di ligelizumab 72mg q4w e/o 120q4w rispetto a placebo e omalizumab 300mg q4w in termini di riduzione settimanale del tasso di gravità del prurito.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed.
    ¿ Male and female subjects = 12 years of age at the time of screening.
    ¿ CSU diagnosis for = 6 months.
    ¿ Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
    ¿ The presence of itch and hives for = 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
    ¿ UAS7 score (range 0-42) = 16 and HSS7 (range 0-21) = 8 during the 7 days prior to randomization (Visit 110, Day 1)
    ¿ Subjects must be on H1-antihistamine at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
    ¿ Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
    ¿ Other protocol-defined inclusion criteria may apply
    ¿ Il consenso informato firmato deve essere ottenuto prima della partecipazione allo studio. Il consenso informato scritto firmato del genitore, o del tutore legale e il consenso del minore, devono essere ottenuti prima di eseguire qualsiasi valutazione. Da notare, se il soggetto raggiunge l'età del consenso adulto (età secondo la legge locale) durante lo studio, dovrà anche firmare il corrispondente modulo di consenso informato (ICF) dello studio alla successiva visita di studio.
    ¿ Soggetti maschi e femmine di età = 12 anni al momento dello screening.
    (NOTA: il reclutamento di soggetti adolescenti, da = 12 a <18 anni, sarà conforme ai requisiti locali).
    ¿ Diagnosi CSU per = 6 mesi.
    ¿ Diagnosi di CSU refrattaria a H1-AH alle dosi approvate al momento della randomizzazione, come definito da quanto segue:
    o La presenza di prurito e ponfi per = 6 settimane consecutive in qualsiasi momento prima di Visit 1 (Giorno - 28 a giorno -14) nonostante l'uso corrente di H1-AH non sedativo
    o Punteggio UAS7 (range 0-42) = 16 e HSS7 (range 0-21) = 8 durante i 7 giorni precedenti la randomizzazione (visita 110, giorno 1)
    o I soggetti devono essere in H1-AH alle sole dosi approvate per il trattamento della CSU a partire dalla visita 1 (giorno da -28 a giorno -14)
    ¿ Volontà e capacità di completare un diario elettronico per i sintomi quotidiani per tutta la durata dello studio e adesione agli orari delle visite di studio.
    E.4Principal exclusion criteria
    History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
    ¿ Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergicor contact-urticaria.
    ¿ Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
    ¿ Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
    ¿ Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
    ¿ Prior exposure to ligelizumab or omalizumab.
    ¿ Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.
    ¿ Other protocol-defined exclusion criteria may apply
    ¿ Storia di ipersensibilità a uno qualsiasi dei farmaci in studio o dei loro eccipienti o a farmaci simili alle classi chimiche (cioè agli anticorpi murini, chimerici o umani).
    ¿ Soggetti con una causa chiaramente definita della loro orticaria cronica, diversa dalla CSU. Ciò include, ma non è limitato a quanto segue: dermografismo sintomatico (uritaria factitia), freddo, calore, solare, pressione, da compressione ritardata, acquageno, colinergico o orticaria da contatto.
    ¿ Malattie, diverse dall'orticaria cronica, con sintomi di orticaria o angioedema come vasculite urticarica, eritema multiforme, mastocitosi cutanea (orticaria pigmentosa) e angioedema ereditario o acquisito (ad es. A causa di deficit di inibitore di C1).
    ¿ Soggetti con evidenza di infezione parassitaria da elminti, come evidenziato dalle feci positive per un organismo patogeno secondo le linee guida locali. Tutti i soggetti saranno screenati per ciò alla Visita 1. Se il test delle feci è positivo per l'organismo patogeno, il soggetto non sarà randomizzato e non potrà essere ri-screenato.
    ¿ Qualsiasi altra malattia della pelle associata a prurito cronico che potrebbe influenzare l’opinione del ricercatore, le valutazioni e i risultati dello studio (ad es. dermatite atopica, bollosa) pemfigoide, dermatite erpetiforme, prurito senile, ecc.).
    ¿ Esposizione precedente a ligelizumab o omalizumab.
    ¿ Qualsiasi antistaminico H2, LTRA (montelukast o zafirlukast) o antistaminici H1 utilizzati a dosi superiori a quelle approvate dopo la visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change from baseline in UAS7 at Week 12
    Cambiamento assoluto rispetto al basale in UAS7 alla settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    ¿ Complete absence of hives and itch at Week 12, assessed as percentage of subjects achieving UAS7 = 0
    ¿ Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12
    ¿ No impact on subjects quality of life at Week 12, assessed as % of subjects achieving DLQI = 0-1
    ¿ Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12
    ¿ Occurrence of treatment emergent adverse events during the study
    ¿ Occurrence of treatment emergent serious adverse events during the study
    Completa assenza di orticaria e prurito alla settimana 12, valutata come percentuale di soggetti che raggiungono UAS7 = 0
    ¿Miglioramento della gravità del prurito, valutato come variazione assoluta rispetto al basale nel punteggio ISS7 alla settimana 12
    ¿Nessun impatto sulla qualità della vita dei soggetti alla settimana 12, valutata come % dei soggetti che raggiungono DLQI = 0-1
    ¿Numero cumulativo di settimane in cui i soggetti ottengono AAS7 = 0 risposte tra il basale e la settimana 12
    Occorrenza di eventi avversi emergenti durante lo studio
    Occorrenza di trattamento per eventi avversi gravi emergenti durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks and at each protocol defined study visit
    12 settimane e ad ogni visita come definito nel protocollo
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    To evaluate the use of rescue medication
    Qualità della vita e valutazione dell'utilizzo della rescue medication
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    Egypt
    India
    Israel
    Japan
    Lebanon
    Mexico
    Philippines
    Russian Federation
    Taiwan
    Tunisia
    United States
    Vietnam
    Belgium
    Estonia
    Finland
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    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
    Completion of the study will be considered when all patients will have
    completed 52 weeks of treatment epoch and the full follow up epoch or
    have prematurely withdrawn from the study
    Il completamento dello studio sarà considerato quando tutti i pazienti avranno
    completato 52 settimane di trattamento e di follow-up oppure si sono ritirati prematuramente dallo studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months29
    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: 950
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 473
    F.4.2.2In the whole clinical trial 1050
    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)
    Patients will be eligible for post-trial access after completion of the
    study.
    Patients will be eligible for post-trial access after completion of the
    study.
    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 Decision2018-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
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