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    Summary
    EudraCT Number:2019-004972-20
    Sponsor's Protocol Code Number:MS200527_0080
    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:2021-01-21
    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 number2019-004972-20
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety.
    Studio di fase III, multicentrico, randomizzato, a gruppi paralleli, in doppio cieco,
    con doppia simulazione, controllato con sostanza attiva per la valutazione
    dell’efficacia e della sicurezza di evobrutinib rispetto a teriflunomide in partecipanti con sclerosi multipla recidivante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis
    Evobrutinib rispetto a teriflunomide in partecipanti con Sclerosi Multipla
    Recidivante.
    A.3.2Name or abbreviated title of the trial where available
    Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1)
    Studio di fase III di evobrutinib nella SMR (EVOLUTION RMS 1)
    A.4.1Sponsor's protocol code numberMS200527_0080
    A.5.4Other Identifiers
    Name:AcronymNumber:Evolution RMS 1
    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 SponsorMERCK HEALTHCARE KGaA
    B.1.3.4CountryGermany
    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 supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.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 nameEvobrutinib
    D.3.2Product code [M2951]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEVOBRUTINIB
    D.3.9.1CAS number 1415823-73-2
    D.3.9.2Current sponsor codeM2951
    D.3.9.3Other descriptive nameMSC2364447C
    D.3.9.4EV Substance CodeSUB188608
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 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 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 AUBAGIO
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    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 nameAubagio
    D.3.2Product code [non applicabile]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    Sclerosi Multipla Recidivante
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    Sclerosi Multipla Recidivante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system 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 demonstrate superior efficacy with evobrutinib compared to Teriflunomide in terms of Annualized Relapse Rate (ARR)
    Dimostrare l’efficacia superiore con evobrutinib rispetto a teriflunomide in termini di tasso d recidiva annualizzato (ARR)
    E.2.2Secondary objectives of the trial
    a.To demonstrate the efficacy of evobrutinib relative to that of Teriflunomide on disability progression
    b.To demonstrate the efficacy of evobrutinib relative to that of Teriflunomide on patient reported symptoms and functional status
    c.To demonstrate the efficacy of evobrutinib relative to that of Teriflunomideon magnetic resonance imaging (MRI) lesion parameters
    d.To characterize the safety and tolerability of evobrutinib.
    e. OLE period: To evaluate the long-term safety, efficacy, and HRQoL of evobrutinib for an additional up to 144 weeks.
    a. Dimostrare l’efficacia di evobrutinib in relazione a quella di teriflunomide sulla progressione della disabilità
    b. Dimostrare l’efficacia di evobrutinib in relazione a quella di teriflunomide sui
    sintomi segnalati dal paziente e sullo stato funzionale
    c. Dimostrare l’efficacia di evobrutinib in relazione a quella di teriflunomide sui
    parametri di lesione della risonanza magnetica per immagini (RMI)
    d. Caratterizzare la sicurezza e la tollerabilità di evobrutinib
    e. Periodo di estensione in aperto: Valutare la sicurezza,
    l’efficacia e la qualità della vita associata alla salute (HRQoL) a lungo termine di evobrutinib per un periodo aggiuntivo di circa 144 settimane
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacokinetic (PK) and Pharmacodynamic (PD) substudies will be performed in selected sites as part of the main protocol. The objective of PK study is to
    characterize the PK profile of evobrutinib in participants with MS and to describe the exposure response relationship between evobrutinib and efficacy endpoints and safety endpoints. The objective of PD sub-study is to describe

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: I sottostudi di farmacocinetica (pharmacokinetics, PK) e di farmacodinamica (pharmacodynamic, PD) saranno eseguiti in centri selezionati nell’ambito del protocollo principale. L’obiettivo dello studio PK è quello di caratterizzare il profilo PK di evobrutinib nei partecipanti con SM e di descrivere il rapporto esposizione-risposta tra evobrutinib e gli endpoint di efficacia e di sicurezza.
    L’obiettivo del sottostudio PD è quello di descrivere il rapporto esposizione-risposta tra evobrutinib e i biomarcatori PD
    E.3Principal inclusion criteria
    - 18 years to 55 years female and male participants
    - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)
    - Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization
    - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
    - Participants are neurologically stable for >= 30 days prior to both screening and baseline
    - Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
    - Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
    - Participants have given written informed consent prior to any study-related procedure
    - Other protocol defined inclusion criteria could apply.
    - Partecipanti di sesso femminile e maschile di età compresa fra 18 anni e 55 anni
    - Partecipanti con diagnosi di SMR (sclerosi multipla recidivante remittente [SMRR] o sclerosi multipla secondaria progressiva [SMSP] con recidive) conformemente ai criteri McDonald aggiornati del 2017 (Thomson 2018).
    - I partecipanti con una o più recidive documentate nei 2 anni precedenti lo screening con: a. una recidiva, verificatasi entro l’ultimo anno prima della randomizzazione, OPPURE b. presenza di almeno 1 lesione captante il gadolinio (Gd+) pesata in T1 nei 6 mesi precedenti alla randomizzazione
    - Punteggio dei partecipanti sulla Scala di Invalidità Espansa (Expanded Disability Status Scale, EDSS) da 0 a 5,5 allo screening e al basale (Giorno 1). I partecipanti con un punteggio EDSS =2 allo Screening e al Basale (Giorno 1) sono idonei alla partecipazione solo se la durata della loro malattia (tempo trascorso dalla comparsa dei sintomi) è pari o inferiore a 10 anni
    - I partecipanti sono neurologicamente stabili per =30 giorni sia prima dello screening che prima del basale
    - Le partecipanti di sesso femminile non devono essere in gravidanza né allattare al seno né essere fertili (come definito da: sterilità da post-menopausa o chirurgica) oppure devono utilizzare un metodo contraccettivo efficace per tutta la durata dello studio e per almeno 2 anni dopo l’intervento dello studio, a causa del lungo periodo di eliminazione per teriflunomide di 2 anni, a meno che la partecipante sia sottoposta a una procedura di eliminazione accelerata
    - I partecipanti di sesso maschile devono astenersi dalla donazione di sperma e/o astenersi dai rapporti sessuali con donne fertili oppure devono usare un metodo contraccettivo efficace per tutta la durata dello studio e per almeno 2 anni dopo l’intervento dello studio, a causa del lungo periodo di eliminazione per teriflunomide di 2 anni, a meno che il partecipante sia sottoposto a una procedura di eliminazione accelerata
    - I partecipanti hanno fornito il consenso informato scritto prima di qualsiasi procedura correlata allo studio
    - Possono essere applicati altri criteri di inclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse.
    - Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening.
    - Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.
    -Other protocol defined exclusion criteria could apply.
    - Partecipanti con diagnosi di SM progressiva, conformemente ai criteri McDonald aggiornati del 2017 come segue: a) Partecipanti con SM primaria progressiva. b) Partecipanti con SM secondaria progressiva senza evidenza di recidiva.
    - Durata della malattia più di (>)10 anni nei partecipanti con un punteggio EDSS =2,0 allo screening.
    - Disturbo immunologico diverso dalla SM o da qualsiasi altra condizione che richieda una terapia corticosteroidea per via orale, endovenosa (EV), intramuscolare o intra-articolare, ad eccezione del diabete mellito di tipo 2 ben controllato o di una malattia tiroidea ben controllata.
    - Possono essere applicati altri criteri di esclusione definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    ARR based on qualified relapses at Week 96 in participants with RMS
    ARR in base alle recidive qualificate alla Settimana 96 nei partecipanti con SMR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 96
    Settimana 96
    E.5.2Secondary end point(s)
    a. Time to first occurrence of 12-week confirmed disability progression (CDP) as measured by the Expanded Disability Status Scale (EDSS) over 96 weeks
    b.Time to first occurrence of 24-week CDP as measured by EDSS over 96 weeks
    c.Change from Baseline (CFB) in Patient Reported Outcomes Measurement Information System [PROMIS] PF score at 96 weeks
    d.CFB in PROMIS Fatigue score at 96 weeks
    e.Total number of T1 Gd+ lesions based on assessments at Week 24, Week 48, and Week 96.
    f. Total number of new or enlarging T2 lesions based on assessments at Week 24, Week 48, and Week 96
    g.Safety as assessed by the nature, severity, and occurrence of adverse events (AEs) and adverse events of special interest (AESIs); vital signs; electrocardiograms (ECGs); absolute concentrations and change from Baseline in immunoglobulin (Ig) levels; and clinical laboratory safety parameters up to Week 108
    h. OLE period:
    •Efficacy and HRQoL endpoints at Weeks 48, 96, and 144
    oARR, based on protocol-defined qualified relapses
    oChange from Baseline in PROMIS PF score
    oChange from Baseline in PROMIS fatigue score
    oChange from Baseline in Medical Outcomes Study 36 Item Short Form Health Survey (SF-36v2)
    •Efficacy and HRQoL endpoints over 144 weeks
    oTime to first occurrence of 12-week confirmed EDSS progression over 144 weeks
    oTime to first occurrence of 24-week confirmed EDSS progression over 144 weeks
    oTime to first occurrence of 12-week confirmed PF deterioration compared to Baseline over 144 weeks
    •Efficacy endpoints at Weeks 24, 48, 96, and 144
    oTotal number of new or enlarging T2 lesions
    oTotal number of T1 Gd+ lesions
    •Safety as assessed by the nature, severity, and occurrence of AEs and AESIs; vital signs; ECGs; absolute concentrations and change from Baseline in Ig levels; clinical laboratory safety parameters up to Week 144
    a. Tempo al primo episodio di progressione della disabilità confermata (CDP) a 12 settimane misurato mediante la Scala dello stato di disabilità espansa (EDSS) nell’ arco di 96 settimane
    b. Tempo al primo episodio di CDP a 24 settimane misurato mediante la scala EDSS nell’ arco di 96 settimane
    c. Variazione rispetto al basale nel punteggio relativo alla funzionalità fisica (PF) secondo il sistema informativo per la misurazione degli esiti riferiti dal paziente (PROMIS) a 96 settimane
    d. Variazione rispetto al basale nel punteggio relativo all’affaticamento secondo il sistema PROMIS a 96 settimane
    e. Numero totale di lesioni Gd+ in T1 in base alle valutazioni della Settimana 24, Settimana 48 e Settimana 96
    f. Numero totale delle lesioni in T2 nuove o ingrandite in base alle valutazioni alla Settimana 24, Settimana 48 e Settimana 96
    g. Sicurezza secondo quanto valutato dalla natura, gravità ed insorgenza di eventi avversi (EA) ed eventi avversi di speciale interesse (AESI), segni vitali, elettrocardiogrammi (ECG), concentrazioni assolute e variazione dal basale nei livelli di immunoglobuline (Ig) e parametri clinici per la sicurezza in laboratorio fino alla Settimana 108
    h. Periodo di estensione in aperto (OLE):
    • Endpoint di efficacia e HRQoL alle Settimane 48, 96 e circa 144
    o ARR, in base alle recidive qualificate come definito nel protocollo
    o Variazione rispetto al basale nel punteggio PF secondo il PROMIS
    o Variazione rispetto al basale nel punteggio relativo all’affaticamento secondo il PROMIS
    o Variazione rispetto al basale nel questionario sullo stato di salute in forma breve a 36 voci per lo studio degli esiti medici (SF-36v2)
    • Endpoint di efficacia e HRQoL nell’arco di 144 settimane
    o Tempo al primo episodio di progressione confermata a 12 settimane in base all’EDSS
    nell’arco di circa 144 settimane
    o Tempo al primo episodio di progressione confermata a 24 settimane in base all’EDSS nell’arco di circa 144 settimane
    o Tempo al primo episodio di deterioramento PF confermato a 12 settimane rispetto al basale nell’arco di circa 144 settimane
    • Endpoint di efficacia alle Settimane 24, 48, 96 e circa 144
    o Numero totale di lesioni in T2 nuove o ingrandite
    o Numero totale di lesioni Gd+ in T1
    • Sicurezza valutata in base a natura, gravità e insorgenza di EA e AESI, segni vitali, ECG, concentrazioni assolute e variazione rispetto al basale nei livelli di Ig e parametri clinici di laboratorio relativi alla sicurezza fino a circa la Settimana 144
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. 12 week over 96 weeks
    b. 24-week over 96 weeks
    c, d: 96 weeks
    e, f: Week 24, Week 48, and Week 96.
    g. Week 108
    h. OLE period timepoints described in E.5.2
    a. 12 Settimane nell’arco di 96 settimane
    b. 24 settimane nell’arco di 96 settimane
    c,d: 96 settimane
    e, f: Settimana 24, Settimana 48, e Settimana 96.
    g. Settimana 108
    h. OLE period timepoints described in E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 Yes
    E.8.1.7.1Other trial design description
    Comparatore attivo (Aubagio) con doppia simulazione
    Active comparator (Aubagio), double-dummy
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA127
    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
    Bosnia and Herzegovina
    Canada
    Chile
    Colombia
    Georgia
    Hong Kong
    India
    Israel
    Korea, Republic of
    Mexico
    Peru
    Russian Federation
    Serbia
    Taiwan
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Czechia
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    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 years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 930
    F.1.3Elderly (>=65 years) No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 930
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2020-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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