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    Summary
    EudraCT Number:2015-001600-64
    Sponsor's Protocol Code Number:RPC01-3102
    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:2021-01-28
    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 number2015-001600-64
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as
    Therapy for Moderate to Severe Ulcerative Colitis
    Sperimentazione di estensione di fase 3, multicentrica, in aperto di RPC1063 per uso orale come terapia per la colite ulcerosa da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).
    Lo scopo di questa sperimentazione ¿ valutare la sicurezza e l¿efficacia a lungo termine di RPC1063 come trattamento per pazienti affetti/e da CU da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis
    Studio dell'efficacia e sicurezza a lungo termine di RPC1063 nella colite ulcerosa
    A.4.1Sponsor's protocol code numberRPC01-3102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02531126
    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 SponsorCELGENE INTERNATIONAL II SàRL
    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 supportCelgene International II S¿rl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReceptos Services, LLC
    B.5.2Functional name of contact pointTruenorth Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address3033 Science Park Road, Suite 300
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018442669299
    B.5.5Fax number0018442669299
    B.5.6E-mailtruenorth@quintiles.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 name0.25 mg RPC1063
    D.3.2Product code RPC1063
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.3Other descriptive name(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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 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 name1.0 mg RPC1063
    D.3.2Product code RPC1063
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.3Other descriptive name(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite Ulcerosa
    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 10045365
    E.1.2Term 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
    To evaluate the long-term safety and efficacy of RPC1063 for the treatment of patients with moderate to severe ulcerative colitits
    L¿obiettivo di questa sperimentazione ¿ valutare la sicurezza e l¿efficacia a lungo termine di RPC1063 come trattamento per pazienti affetti/e da Colite Ulcerosa da moderata a grave.
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabili
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previously participated in a trial of RPC1063 for UC and meet the
    criteria for participation in the open label extension as outlined in the
    prior trial
    2. Men and women of childbearing potential must agree to use adequate
    birth control measures during the trial. Acceptable methods of birth
    control in this trial include: surgical sterilization, intrauterine device,
    oral contraceptive, contraceptive patch, long acting injectable
    contraceptive, partner's vasectomy, double-barrier method (condom
    or diaphragm with spermicide or condom and diaphragm) or abstinence
    during trial participation and for 30 days after their last dose of
    investigational drug. Patients must follow the strictest applicable local
    requirement as specified by the Regulatory Agency or Ethics Committee
    approving the trial
    3. Must be able and willing to adhere to the trial visit schedule and
    comply with other protocol requirements
    4. Provide written informed consent, which must be obtained prior to
    any trial-related procedures
    Pazienti che hanno già partecipato a una sperimentazione con RPC1063 per CU e che soddisfano i criteri per la partecipazione all’estensione in aperto, come illustrato nella precedente sperimentazione
    2. I soggetti di sesso maschile e femminile fertili devono acconsentire all’adozione di misure per il controllo delle nascite adeguati durante la sperimentazione. Le misure per il controllo delle nascite in questa sperimentazione includono: sterilizzazione chirurgica, dispositivo intrauterino, contraccettivo orale, cerotto contraccettivo, contraccettivo iniettabile a lunga durata d’azione, vasectomia del compagno, metodo di doppia barriera (preservativo o diaframma con spermicida o preservativo con diaframma) o astinenza durante la partecipazione alla sperimentazione e per 30 giorni successivi all’ultima dose del farmaco sperimentale. I/le pazienti devono seguire i requisiti locali in vigore più rigorosi come specificato dall’Agenzia regolatoria o dal Comitato etico che ha approvato la sperimentazione.
    3. Disponibilità e capacità di rispettare il programma delle visite della sperimentazione e gli altri requisiti del protocollo.
    4. Fornire un consenso informato scritto, che deve essere ottenuto prima di qualsiasi procedura correlata alla sperimentazione.
    E.4Principal exclusion criteria
    Exclusions Related to Medications:
    1. Have received any of the following therapies since the first dose of investigational drug in the prior RPC1063 trial:
    • Treatment with a biologic agent
    • Treatment with an investigational agent other than RPC1063
    • Treatment with D-penicillamine, leflunomide, thalidomide, natalizumab or fingolimod
    • Treatment with lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
    • Treatment with a live vaccine within 4 weeks prior to Visit 1 of this trial
    2. Are currently receiving or require initiation of any of the following therapies:
    • Treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg
    • Treatment with immunosuppressive agents (e.g., azathioprine, 6-MP, or methotrexate)
    • Chronic treatment with therapies that strongly inhibit or induce cytochrome P450 3A4 (CYP3A4) metabolism
    • Chronic non-steroidal anti-inflammatory drug (NSAID) use (Note: occasional use of NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day is permitted)
    • Treatment with medications with a known impact on the cardiac conduction system (e.g., beta blockers, diltiazem, verapamil, and Class Ia or Class III anti-arrhythmic drugs)
    Exclusions Related to General Health:
    3. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG)
    4. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial difficult or that would put the patient at risk by participating in the trial or that would have required a patient to discontinue treatment in previous RPC1063 trial
    5. Clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea
    Exclusions Related to Laboratory Results:
    6. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN), or direct bilirubin 3 times the ULN
    7. FEV1 or FVC < 50% of predicted values
    Esclusioni correlate ai farmaci:
    1. Avere ricevuto una qualsiasi delle seguenti terapie dalla prima dose del farmaco sperimentale nella precedente sperimentazione con RPC1063:
    • Trattamento con un agente biologico
    • Trattamento con un agente sperimentale diverso da RPC1063
    • Trattamento con D-penicillamina, leflunomide, talidomide, natalizumab o fingolimod
    • Trattamento con terapie per la deplezione dei linfociti (ad es. Campath, anti-CD4, cladribina, rituximab, ocrelizumab, ciclofosfamide, mitoxantrone, irradiazione corporea totale, trapianto di midollo osseo, alemtuzumab, daclizumab)
    • Trattamento con un vaccino vivo nelle 4 settimane precedenti la Visita 1 di questa sperimentazione
    2. Ricevere attualmente o richiedere l’avvio di una qualsiasi delle seguenti terapie:
    • Trattamento con corticosteroidi ad una dose che superi l’equivalente di prednisone da 40 mg
    • Trattamento con agenti immunosoppressivi (ad es. azatioprina, 6-MP o metotrexato)
    • Trattamento cronico con terapie che inibiscano fortemente o inducano il metabolismo del citocromo P450 3A4 (CYP3A4)
    • Uso di farmaci anti-infiammatori non steroidei (FANS) cronici. (Nota: è consentito l’uso occasionale di FANS e acetaminofene [ad es. per cefalea, artrite, mialgie o dolori mestruali] e aspirina fino a 325 mg/die)
    • Trattamento con farmaci con un noto impatto sul sistema di conduzione cardiaca (ad es. beta-bloccanti, diltiazem, verapamil e farmaci antiaritmici di classe Ia o di classe III)
    Esclusioni correlate alla salute generale:
    3. Gravidanza, allattamento, o positività all’esame su siero della subunità ß della gonadotropina corionica umana (ß-human chorionic gonadotropin, ß-hCG)
    4. Malattia epatica, neurologica, polmonare, oftalmologica, endocrina, psichiatrica clinicamente rilevante, o altre importanti malattie sistemiche che rendono difficile l’attuazione del protocollo o l’interpretazione della sperimentazione o che metterebbero il/la paziente a rischio con la partecipazione alla sperimentazione o che avrebbero richiesto il ritiro di un/a paziente dal trattamento nella precedente sperimentazione con RPC1063
    5. Condizioni cardiovascolari clinicamente rilevanti, tra cui storia o presenza di recente infarto miocardico, angina instabile, ictus, attacco ischemico transitorio, scompenso cardiaco richiedente il ricovero, insufficienza cardiaca di classe III/IV, sindrome del seno malato o grave apnea del sonno non trattata
    Esclusioni correlate alle risultanze di laboratorio:
    6. Alterazione della funzionalità epatica o persistenti aumenti dei livelli di aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) ¿ 5 volte il limite superiore della norma (upper limit of normal, ULN) o di bilirubina diretta ¿ 3 volte l’ULN
    7. Volume espiratorio forzato a 1 secondo (forced expiratory volume in the first second, FEV1) o capacità vitale forzata (forced vital capacity, FVC) < 50% dei valori attesi
    E.5 End points
    E.5.1Primary end point(s)
    En:
    Due to the open-label nature of the trial and the lack of a control group, all data will be summarized and no hypothesis testing will be performed. Each efficacy endpoint will be summarized and 95% confidence intervals around the estimates may also be presented. Efficacy Endpoints: • Proportion of patients in clinical remission. • Proportion of patients with a clinical response • Proportion of patients with endoscopic improvement • Proportion of patients with mucosal healing • Proportion of patients with corticosteroid-free remission • Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score• Proportion of patients with histologic remission • Proportion of patients with clinical response, clinical remission, or endoscopic improvement in patients who had previously received anti-TNF therapy
    Safety Endpoints:
    The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), TEAEs leading to discontinuation of investigational drug, and TEAEs of special interest will be summarized, as well as changes from Baseline for clinical laboratory measures, vital signs, ECGs, and pulmonary function tests.
    A causa della natura in aperto della sperimentazione e della mancanza di un gruppo di controllo, tutti i dati saranno riepilogati e non sarà effettuata alcuna verifica dell’ipotesi. Ogni endpoint di efficacia sarà riassunto e potranno anche essere presentati intervalli di confidenza del 95% attorno alle stime.. Endpoint di Efficacia : • Percentuale di pazienti in remissione clinica • Percentuale di pazienti con una risposta clinica • Percentuale di pazienti con miglioramento endoscopico • Percentuale di pazienti con guarigione mucosale • Percentuale di pazienti con remissione senza corticosteroidi • Variazione rispetto al basale nel punteggio Mayo completo, parziale, e nella scala a 9 punti • Percentuale di pazienti con remissione istologica • Percentuale di pazienti con risposta clinica, remissione clinica o miglioramento endoscopico in pazienti che hanno ricevuto in precedenza una terapia anti-TNF
    Gli endpoint di sicurezza: L’incidenza, la gravità e il rapporto di eventi avversi emergenti dal trattamento (TEAE), eventi avversi seri (SAE), TEAE che comportano l’interruzione del farmaco sperimentale e TEAE di particolare interesse. Variazioni clinicamente significative dal basale su misure di laboratorio cliniche, segni vitali, ECG, test di funzionalità polmonare, esami obiettivi e tomografia a coerenza ottica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy assessments will be performed at the following visits; Day 1 (Baseline/Visit 1) - All Week 5 (Visit 2) Week 10 (Visit 3) Week 16 (Visit 4) Week 22 (Visit 5) Thereafter, additional visits at 12-week intervals (Visit 5 onwards). Partial Mayo partial score assessment to be performed at each visit. Full Mayo score assessment performed at Visit 1, Visit 7, at each additional visit (12-week intervals), and at the End of Treatment/Early Termination Visit. Endoscopy and colonic biopsies will be performed at Week 1, Visit 7, at each additional visit (12-week intervals), and at the End of Treatment/Early Termination Visit.
    Le valutazioni di efficacia si svolgeranno presso le seguenti visite; Giorno 1 (basale/Visita 1) - tutti Settimana 5 (Visita 2) Settimana 10 (Visita 3) Settimana 16 (Visita 4) Settimana 22 (Visita 5) Successivamente, ulteriori visite ad intervalli di 12 settimane (dalla Visita 5 in poi). La valutazione del punteggio parziale Mayo verrà eseguire ad ogni visita. La completa valutazione del punteggio Mayo verrà effettuata alla Visita 1, Visita 7, ad ogni visita aggiuntiva (ad intervalli di 12 settimane), ed alla fine del trattamento/Visita di conclusione anticipata. Endoscopia e bioposia del colon saranno eseguite alla settimana 1, visita 7, ad ogni visita aggiuntiva (con intervalli di 12 settimane), e alla fine del Trattamento /Visita di conclusione anticipata.
    E.5.2Secondary end point(s)
    not applicable
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    not applicable
    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 No
    E.6.7Pharmacodynamic No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    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
    Belarus
    Canada
    Chile
    Colombia
    Israel
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    South Africa
    Ukraine
    United States
    Belgium
    Bulgaria
    Czechia
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Slovakia
    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
    Patients will receive treatment until the end of 2021, or until marketing approval of RPC1063 for UC is obtained in their country, or until the Sponsor discontinues the development program.
    I pazienti riceveranno il trattamento fino alla fine del 2021 o fino all'autorizzazione all'immissione in commercio di RPC1063 per CU ottenuta nel proprio Paese, o finché lo Sponsor non interrompe il programma di sviluppo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days23
    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 days25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 614
    F.4.2.2In the whole clinical trial 1350
    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)
    Expected normal treatment for the condition
    trattamento standard previsto per la patologia
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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