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    Summary
    EudraCT Number:2019-000733-39
    Sponsor's Protocol Code Number:ABX464-104
    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:2021-01-22
    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 number2019-000733-39
    A.3Full title of the trial
    A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
    Studio di fase 2b, in aperto, per valutare l’efficacia e la sicurezza di ABX464 come terapia di mantenimento in pazienti con colite ulcerosa da moderata a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients
    Terapia di mantenimento in aperto in pazienti con colite ulcerosa da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberABX464-104
    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 SponsorAbivax
    B.1.3.4CountryFrance
    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 supportABIVAX
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABIVAX
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address5 Rue de la Baume
    B.5.3.2Town/ cityParigi
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033153830961
    B.5.6E-mailPaul.Gineste@abivax.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 nameABX464
    D.3.2Product code [ABX464]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Ulcerative Colitis
    Colite ulcerosa da moderata a grave
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous.This causes abdominal discomfort and frequent emptying of the colon (diarrhoea).
    Nella colite ulcerosa il rivestimento del colon si infiamma e sviluppa minuscole piaghe aperte che producono pus e muco. Questo provoca disagio addominale e frequenti svuotamenti del colon (diarrea).
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 assess in all patients the long-term efficacy of ABX464 given at 50 mg QD on clinical remission at week 48 compared to the induction study baseline (ISB).
    L’obiettivo primario dello studio è valutare in tutti i pazienti l’efficacia a lungo termine di ABX464 somministrato a una dose di 50 mg QD alla remissione clinica alla Settimana 48 rispetto al basale dello studio di induzione (ISB).
    E.2.2Secondary objectives of the trial
    To evaluate:
    -the clinical remission at week 48 compared to the baseline of the open label study (BOLS)
    - the proportion of patients with glucocorticoid-free clinical remission at W48
    -the effect of ABX464 50 mg QD:
    ~on Modified Mayo Score at week 48 and on partial MMS, among patients, at every study visit compared to ISB (Induction study baseline)
    ~on endoscopic improvement and remission and sustained endoscopic improvement and remission, by segment at W48 compared to ISB and BOLS
    ~on stool and rectal bleeding frequency at every study visit compared to BOLS
    ~on fecal calprotectin and CRP levels at W24 and W48 visits compared to BOLS
    ~on clinical response at W48 compared to ISB and BOLS
    ~on miR-124 expression in colon tissue (RNA later) and at W48 and in total blood at W24 and W48
    ~on patients' quality of life at W24 and W48 compared to BOLS
    ~on the rectal/sigmoidal infiltrates at W48 compared to ISB and BOLS
    -the long-term safety profile of ABX464 50 mg QD
    Valutare:
    - la remissione clinica alla wk48 rispetto al basale dello studio in aperto (BOLS)
    - la percentuale di pazienti con remissione clinica libera da glucocorticoidi alla wk48
    - l’effetto di ABX464 50 mg QD su:
    punteggio Mayo modificato (MMS) alla wk48 e sul pMMS, tra tutti i pazienti, in occasione di ogni visita dello studio rispetto all’ISB
    miglioramento e la remissione endoscopici e sul miglioramento e la remissione endoscopici sostenuti, per segmento, alla wk48 rispetto all’ISB e al BOLS
    frequenza di defecazione e la proctorragia in occasione di ogni visita dello studio rispetto al BOLS
    livelli di calprotectina fecale e di PCR alle visite della wk24 e della wk48 rispetto al BOLS
    risposta clinica alla wk48 rispetto all’ISB e al BOLS
    espressione di miR-124 nel tessuto del colon (RNAlater) alla wk48 e nel sangue tot alla wk24 e wk48
    QoL dei pazienti misurata tramite IBDQ alla wk24 e wk48 rispetto al BOLS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following:
    criteria are met:¿ Patients must have completed the 16-week induction treatment period (ABX464-103);
    ¿ Patients are able and willing to comply with study visits and procedures as per protocol;
    ¿ Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed;
    ¿ Patients should be affiliated to a social security regimen (for French sites only);
    ¿ Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6
    months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile or if of childbearing potential must use a highly
    effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required.
    Un paziente sarà ritenuto idoneo a partecipare a questo studio se soddisfa TUTTI i seguenti criteri:
    ¿ I pazienti devono avere completato il periodo di trattamento di induzione di 16 settimane (ABX464-103);
    ¿ I pazienti sono in grado e disposti a rispettare le visite e le procedure dello studio come da protocollo;
    ¿ I pazienti devono comprendere, firmare e datare il modulo di consenso informato volontario scritto prima dell’esecuzione di qualsiasi procedura specifica del protocollo;
    ¿ I pazienti devono essere iscritti a un sistema di previdenza sociale (solo per i centri francesi);
    ¿ Le donne e gli uomini che ricevono il trattamento in studio (potenzialmente in combinazione con un immunosoppressore), e i relativi compagni, devono acconsentire a utilizzare un metodo contraccettivo altamente efficace durante lo studio e nei 6 mesi (180 giorni) successivi al termine dello studio o alla sua interruzione anticipata. La contraccezione deve essere in atto almeno 2 settimane prima dello screening. Le donne devono essere chirurgicamente sterili o, se fertili, devono utilizzare un metodo contraccettivo altamente efficace. Le donne fertili (WOCBP) inizieranno lo studio dopo una mestruazione confermata e un risultato negativo al test di gravidanza. I metodi contraccettivi altamente efficaci includono l’astinenza completa, i dispositivi intrauterini (IUD) o i contraccettivi ormonali mirati all’inibizione dell’ovulazione, i sistemi intrauterini a rilascio ormonale, la legatura delle tube bilaterale, la vasectomia del compagno. L’astinenza completa è definita quando ciò è in linea con lo stile di vita preferito e usuale del paziente. Per ogni caso di ritardo delle mestruazioni (su un periodo di un mese tra le mestruazioni) è richiesta la conferma dell’assenza di gravidanza. Questo è valido anche per le WOCBP con cicli mestruali infrequenti o irregolari. I pazienti di sesso femminile e maschile non devono stare pianificando una gravidanza nel periodo della sperimentazione e nei 6 mesi successivi al completamento della loro partecipazione alla sperimentazione. Inoltre, i pazienti di sesso maschile devono utilizzare il preservativo durante la sperimentazione e per 6 mesi (180 giorni) dopo il termine della loro partecipazione allo studio. I pazienti di sesso maschile non devono donare sperma per tutto il periodo in cui è richiesta la contraccezione.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
    ¿ Patients who had major protocol deviation(s) in the induction study;
    ¿ Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product;
    ¿ Patients who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or
    she participates in the study;
    ¿ Patients with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
    ¿ Patients who are participating or plan to participate in other investigational studies (other than induction study) during the study.
    I pazienti che soddisfano uno qualsiasi dei seguenti criteri di esclusione devono essere esclusi dallo studio:
    ¿ I pazienti che presentavano una o più deviazioni importanti dal protocollo nello studio di induzione;
    ¿ I pazienti che hanno interrotto permanentemente il trattamento dello studio di induzione (ABX464-103) a causa di un evento avverso (EA), indipendentemente dalla correlazione con il prodotto sperimentale;
    ¿ I pazienti che hanno sviluppato qualsiasi malattia/condizione maggiore o evidenza di una condizione clinica instabile (eccetto la CU) che, a giudizio dello sperimentatore, aumenterebbe sostanzialmente il rischio per il soggetto se questi partecipasse allo studio;
    ¿ I pazienti con altre condizioni mediche o psichiatriche acute o croniche gravi o anomalie negli esami di laboratorio o nell’elettrocardiogramma (ECG) che potrebbero aumentare il rischio associato alla partecipazione allo studio o alla somministrazione di prodotti sperimentali o potrebbero interferire con l’interpretazione dei risultati dello studio e che, a parere dello sperimentatore, renderebbero il paziente inadatto all’inclusione in questo studio;
    ¿ I pazienti che stanno partecipando o che hanno in programma di partecipare ad altri studi sperimentali (diversi dallo studio di induzione) durante lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with clinical remission at week 48 compared to induction study baseline.
    Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, AND an endoscopy sub-score =1 (excluding friability), AND at least 1- point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score =1.
    Percentuale di pazienti con remissione clinica alla Settimana 48 rispetto al basale dello studio di induzione.
    La remissione clinica (sulla base del sistema di punteggio Mayo) è definita come: un sottopunteggio di proctorragia = 0 E un sottopunteggio endoscopico =1 (esclusa la friabilità) E una riduzione di almeno 1 punto nel sottopunteggio della frequenza di defecazione rispetto al basale con ottenimento di un sottopunteggio della frequenza di defecazione =1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 48
    Alla Settimana 48
    E.5.2Secondary end point(s)
    ¿Reduction relative to baseline in Modified Mayo Score at week 48 and in partial Modified Mayo Score at every study visit among all patients.
    ¿Proportion of patients with either endoscopic improvement or/and endoscopic remission by segment at week 48 among all patients.
    Endoscopic improvement is defined as a Mayo endoscopic sub score of =1 (excluding friability). Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
    ¿Proportion of patients with sustained endoscopic improvement at week 48. Sustained endoscopic improvement is defined as the number of patients with endoscopic improvement at week 48 among patients who had endoscopic improvement during the Induction study (at week 8 or week 16).
    ¿Proportion of patients with glucocorticoid-free clinical remission at week 48. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 8 weeks prior to week 48.
    ¿Reduction relative to baseline in stool and rectal bleeding frequency at every study visit.
    ¿Reduction relative to baseline in fecal calprotectin and CRP levels at week 24 and 48.
    ¿Proportion of patients with clinical response at week 48.
    Clinical response is defined as: a reduction in Mayo Score = 3 points and = 30 % from baseline with an accompanying decrease in rectal bleeding sub-score = 1 point or absolute rectal bleeding sub-score = 1 point.
    ¿Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
    ¿Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domains at week 24 and 48.
    ¿ Reduction relative to ISB of infiltrate/histopathology (rectal/sigmoidal biopsies) using the Robarts Histopathology Index (RHI), the Geboes and Nancy Histology Scoring Scales at week 48.
    ¿Number and rate of all adverse events, causally-related adverse events, all SAE and causallyrelated SAEs classified by severity.
    ¿Incidence of treatment-emergent serious adverse event, hospitalizations, total inpatient days.
    ¿Incidence of adverse events leading to investigational product discontinuation.
    ¿Number of clinically significant laboratory abnormalities.
    ¿ Riduzione rispetto al basale nel punteggio Mayo modificato alla Settimana 48 e nel punteggio Mayo modificato parziale in occasione di ogni visita dello studio tra tutti i pazienti.
    ¿ Percentuale di pazienti con miglioramento endoscopico o/e remissione endoscopica per segmento alla Settimana 48 fra tutti i pazienti
    Il miglioramento endoscopico è definito da un sottopunteggio endoscopico Mayo =1 (esclusa la friabilità). La remissione endoscopica è definita come un sottopunteggio pari a 0.
    ¿ Percentuale di pazienti con miglioramento endoscopico sostenuto alla Settimana 48. Il miglioramento endoscopico sostenuto è definito come il numero di pazienti con miglioramento endoscopico alla Settimana 48 fra i pazienti che hanno avuto un miglioramento endoscopico durante lo studio di induzione (alla Settimana 8 e alla Settimana 16).
    ¿ Percentuale di pazienti con remissione clinica libera da glucocorticoidi alla Settimana 48.
    La remissione clinica libera da glucocorticoidi è definita come remissione clinica in aggiunta alla non necessità di trattamento con glucocorticoidi per almeno 8 settimane prima della Settimana 48.
    ¿ Riduzione rispetto al basale della frequenza di defecazione e della proctorragia in occasione di ogni visita dello studio.
    ¿ Riduzione rispetto al basale dei livelli di calprotectina fecale e PCR alla Settimana 24 e 48.
    ¿ Percentuale di pazienti con una risposta clinica alla Settimana 48.
    La risposta clinica è definita come: una riduzione nel punteggio Mayo =3 punti e =30% rispetto al basale, che si accompagna a una riduzione del sottopunteggio di proctorragia =1 punto o un sottopunteggio assoluto di proctorragia =1 punto.
    ¿ Variazione rispetto al basale dell’espressione di miRNA-124 nelle biopsie rettali/sigmoidee alla Settimana 48 e nel sangue intero alla Settimana 24 e alla Settimana 48.
    ¿ Punteggi e variazioni dal basale nei domini del Questionario sulla malattia infiammatoria intestinale (IBDQ) alla Settimana 24 e 48.
    ¿ Riduzione rispetto all’ISB dell’infiltrato/istopatologia (biopsie rettali/sigmoidee) utilizzando l’indice istopatologico dell’Istituto di ricerca Robarts (RHI) e le scale di valutazione istologica di Geboes e Nancy alla Settimana 48.
    ¿ Numero e percentuale di tutti gli eventi avversi (EA), degli eventi avversi con correlazione casuale, di tutti gli eventi avversi seri (EAS) e di tutti gli EAS con correlazione casuale, classificati in base alla gravità.
    ¿ Incidenza di eventi avversi seri emergenti dal trattamento, ricoveri ospedalieri, giorni di ricovero totali.
    ¿ Incidenza di eventi avversi che determinano l’interruzione del prodotto sperimentale.
    ¿ Numero di anomalie di laboratorio clinicamente significative.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) MMS at week 48 and pMMS at every visit
    2) at week 48
    3) at week 48
    4) at week 48
    5) at every study visit
    6) at week 24 and 48
    7) at week 48
    8) at week 24 and 48
    9) at week 24 and 48
    10) at week 48
    11) through the study
    12) through the study
    13) through the study
    14) through the study
    1) MMS alla Settimana 48 e pMMS a ogni altra visita
    2) alla Settimana 48
    3) alla Settimana 48
    4) alla Settimana 48
    5) a ogni altra visita
    6) at week 24 and 48
    7) alla Settimana 48
    8) alla Settimana 24 e 48
    9) alla Settimana 24 e 48
    10) alla settimana 48
    11) per tutto lo studio
    12) per tutto lo studio
    13) per tutto lo studio
    14) per tutto lo studio
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Austria
    Belarus
    Belgium
    Canada
    Czechia
    France
    Germany
    Hungary
    Ireland
    Netherlands
    Poland
    Serbia
    Slovakia
    Slovenia
    Spain
    Ukraine
    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 years2
    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 years2
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 202
    F.4.2.2In the whole clinical trial 232
    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)
    No plans for treatment post-trial participation
    Non ci sono piani per il trattamento post-sperimentazione.
    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 Decision2020-01-08
    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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