Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001953-28
    Sponsor's Protocol Code Number:EFC15804
    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:2021-01-13
    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 number2018-001953-28
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation
    Studio pilota randomizzato,in doppio cieco, controllato con placebo,a gruppi paralleli della durata di 52 settimane volto a valutare l’efficacia, la sicurezza e la tollerabilità di dupilumab in pazienti con broncopneumopatia cronica ostruttiva (BPCO) da moderata a grave con infiammazione di tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pivotal study to assess the efficacy, safety and tolerability of dupilumab in patients with moderate-to-severe COPD with Type 2 inflammation (BOREAS)
    Studio pilota per valutare l’efficacia,la sicurezza e la tollerabilità di dupilumab in pazienti con BPCO da moderata a grave con infiammazione di tipo 2 (BOREAS)
    A.3.2Name or abbreviated title of the trial where available
    BOREAS
    BOREAS
    A.4.1Sponsor's protocol code numberEFC15804
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1211-8804
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street Addressviale Bodio 37/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 namedupilumab
    D.3.2Product code [SAR231893]
    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 INNdupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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 obstructive pulmonary disease
    broncopneumopatia cronica ostruttiva
    E.1.1.1Medical condition in easily understood language
    COPD
    BPCO
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by
    - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD)
    Valutare l’efficacia di dupilumab somministrato ogni 2 settimane in pazienti con broncopneumopatia cronico ostruttiva (BPCO) moderata o grave, misurata come:
    •Tasso annualizzato di esacerbazione acuta di BPCO (EABPCO) moderata o grave
    E.2.2Secondary objectives of the trial
    To evaluate the effect of dupilumab administered every 2 weeks on
    - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
    - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)
    - Pre-bronchodilator FEV1 over 52 weeks compared to placebo
    - Lung function assessments
    - Moderate and severe COPD exacerbations
    - To evaluate safety and tolerability
    - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)
    Valutare l’effetto di dupilumab ogni 2 settimane su
    • Volume espiratorio forzato in 1 secondo (FEV1) pre-broncodilatatore nell’arco di 12 settimane rispetto a placebo
    • Qualità della vita correlata alla salute, valutata in base alla variazione dal basale alla Settimana 52 nel Questionario respiratorio di St. George (SGRQ)
    • FEV1 pre-broncodilatatore nell’arco di 52 settimane rispetto al placebo
    •valutazione della funzionalità polmonare
    •esacerbazione della BPCO moderata e grave
    •valutare la sicurezza e la tollerabilità
    •valutare l'esposizone sistemica a dupilumab e l'incidenza di anticorpo anti farmaco ( ADA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participants with a physician diagnosis of COPD who meet the following criteria:
    -Current or former smokers with a smoking history of >/=10 pack-years.
    -Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] </= 70% and post-bronchodilator FEV1 % predicted >30% and </=70%).
    -Medical Research Council (MRC) Dyspnea Scale grade >/=2.
    -Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
    -Documented history of high exacerbation risk defined as exacerbation history of >/=2 moderate or >/=1 severe within the year prior to inclusion. taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic agonist (LAMA) (or LABA/LAMA if ICS is contraindicated).
    Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics.
    One of the two required moderate exacerbations has to require the use of systemic corticosteriods.
    Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization/emergency room visit or treatment for >24 hours in emergency department/urgent care facility or result in death.
    -Background triple therapy (inhaled corticosteroid [ICS] + long acting beta agonist [LABA] + long acting muscarinic agonist [LAMA]) for 3 months prior to randomization with a stable dose of medication for >/= 1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
    -Evidence of Type 2 inflammation: Patients with blood eosinophils >/=300 cells/microliter at Visit 1..
    Partecipanti con una diagnosi clinica di BPCO che incontrino i seguenti criteri:
    - Fumatori o ex fumatori con una storia di tabagismo >/=10 pack-years
    - BPCO da moderata a severa (FEV1/FVC </=70% post-broncodilatazione e FEV1 % predetta >30% e </= 70% post-broncodilatazione)
    - Medical Research Council (MRC) Dyspnea Scale di grado >/=2.
    - Storia riferita dai pazienti di segni e sintomi di bronchite (tosse produttiva cronica) per 3 mesi in un anno fino allo screening in assenza di altre cause note di tosse cronica
    - Anamnesi documentata di rischio di riacutizzazione elevato definita come una storia di riacutizzazioni moderate >/= 2 o riacutizzazione severa >/=1 nell’anno precedente all’inclusione nello studio. Almeno una riacutizzazione dovrebbe essersi verificata mentre il paziente stava assumendo la tripla terapia di base ICS+LAMA+LABA (oppure doppia terapia
    LAMA+LABA consentita solo in caso di controindicazione per ICS)
    Le riacutizzazioni moderate sono registrate dallo Sperimentatore e definite come EABPCO e richiedono corticosteroidi sistemici (intramuscolari (IM), endovena, o orali) e/o antibiotici. Una delle due riacutizzazioni moderate deve richiedere l’utilizzo di corticosteroidi sistemici.
    Le riacutizzazioni severe sono registrate dallo Sperimentatore e definite come EABPCO che richiedano ricovero in ospedale /permanenza al pronto soccorso/assistenza urgente
    superiore alle 24 ore o che causano il decesso.
    - Tripla terapia di base (corticosteroidi inalanti ICS+ beta agonisti a lunga azione LABA+ agonisti muscarinici a lunga azione LAMA) per 3 mesi prima della randomizzazione con dose stabile >/= 1 mese prima di Visita 1; Doppia terapia (LABA+ LAMA) consentita solo in caso di controindicazione per ICS
    Evidenza di infiammazione di tipo 2: Pazienti con conteggio di eosinofili nel sangue >/=300 cellulle per microlitro alla Visita 1.
    E.4Principal exclusion criteria
    - COPD diagnosis for less than 12 months prior to randomization.
    - A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines; or a history of asthma with age of onset >/= 40 years of age.
    - Significant pulmonary disease other than COPD (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
    - Cor pulmonale, evidence of right cardiac failure.
    - Treatment with oxygen of more than 12 hours per day.
    - Hypercapnia requiring Bi-level ventilation.
    - AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
    - Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
    - History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).
    - Diagnosis of alfa-1 anti-trypsin deficiency..
    -Diagnosi di BPCO inferiore ai 12 mesi prima della randomizzazione
    -Diagnosi attuale di asma o storia pregressa di asma in accordo alle linee-guida Global Initiative for Asthma (GINA) del 2018 o in accordo ad altre linee-guida accettate; o qualsiasi storia di diagnosi di asma >/= 40 anni di età
    - Malattia polmonare significativa diversa dalla BPCO (ad es. Fibrosi polmonare, sarcoidosi, malattia polmonare interstiziale, ipertensione polmonare, bronchiectasie, sindrome di Churg-Strauss ecc.) o un'altra malattia polmonare o sistemica diagnosticata associata a conteggi elevati di eosinofili periferici.
    - Cuore Polmonare, evidenza di insufficienza cardiaca destra
    -Trattamento con ossigeno per più di 12 ore al giorno.
    -Ipercapnia che richieda BiPAP
    -Riacutizzazione severa di BPCO (EABPCO, come definite nei criteri di inclusione) entro 4 settimane prima, o durante il periodo di screening.
    Infezione delle vie respiratorie entro 4 settimane prima dello screening, o durante il periodo di screening.
    Anamnesi o pneumonectomia programmata o chirurgia di riduzione del volume polmonare. Pazienti che partecipano alla fase acuta di un programma di riabilitazione polmonare, cioè che hanno iniziato la riabilitazione <4 settimane prima dello screening (Nota: i pazienti nella fase di mantenimento di un programma di riabilitazione possono essere inclusi)
    Diagnosi di deficit di alfa-1 anti-tripsina.
    E.5 End points
    E.5.1Primary end point(s)
    1. Annual rate of acute COPD exacerbation (AECOPD) : Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo
    1.Tasso annualizzato di esacerbazioni di BPCO: Tasso annualizzato di esacerbazioni di BPCO moderate o gravi nell’arco del periodo di trattamento di 52 settimane rispetto a placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to week 52
    1. dal basale alla settimana 52
    E.5.2Secondary end point(s)
    1. Change in pre-bronchodilator FEV1 : Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo
    2. Change in SGRQ : Change from baseline to Week 52 in SGRQ total score compared to placebo
    3. Improvement in SGRQ : Proportion of patients with SGRQ improvement >/=4 points at Week 52
    4. Change in pre-bronchodilator FEV1 from baseline to Week 52 : Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo
    5. Change in pre-bronchodilator FEV1 from baseline to time points up to Week 48 : Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 16, 20, 24, 28, 36, 44 and 48) compared to placebo
    6. Change in post-bronchodilator FEV1 lung function : Change in postbronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo
    7. Change in forced expiratory flow (FEF) 25-75% : Change in FEF 25- 75% from baseline to Weeks 2, 4, 8, 12, 16, 24, 28, 36, 44 and 52
    8. Annualized rate of severe AECOPD : Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period
    9. Time to first AECOPD : Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period
    10. Adverse events : Number of adverse events (AEs)/treatmentemergent adverse events (TEAEs)
    11. Potentially clinically significant abnormality (PCSA) in laboratory tests : Percentage of patients with at least one incidence of PCSA
    12. Anti-drug antibodies : Incidence of anti-drug antibodies against dupilumab
    1. Variazione nel FEV1 pre-broncodilatatore: Variazione nel FEV1 pre-broncodilatatore dal basale alla Settimana 12 rispetto a placebo
    2.Variazione nel punteggio totale SGRQ: Variazione dal basale alla Settimana 52 nel punteggio totale SGRQ rispetto a placebo
    3. Miglioramento del punteggio SGRQ: Percentuale di pazienti con miglioramento del punteggio SGRQ >/=4 punti alla Settimana 52
    4.Variazione nel FEV1 pre-broncodilatatore dal basale alla Settimana 52 :Variazione nel FEV1 pre-broncodilatatore dal basale alla Settimana 52 rispetto a placebo
    5.Variazione nel FEV1 pre-broncodilatatore dal basale alla Settimana 48 rispetto a placebo: Variazione nel FEV1 pre-broncodilatatore dal basale alle Settimane diverse dalla 12 e 52 ( cioè settimana 2, 4, 8, 16, 20, 24, 28,36,44 e 48) rispetto a placebo
    6.Variazione nel FEV1 post-broncodilatatore: Variazione nel FEV1 post-broncodilatatore dal basale alle Settimane 2, 4, 8, 12, 24, 36 e 52 rispetto a placebo
    7.cambiamento nel flusso espiratorio forzato (FEF) 25-75% dal basale alle settimane 2,4,8,12,16,24,28,36,44,e 52
    8.Tasso annualizzato di esacerbazioni gravi di BPCO (EABPCO): Tasso annualizzato di esacerbazioni gravi di BPCO rispetto a placebo nell'arco delle 52 settimane di trattamento
    9. tempo alla prima manifestazione del esacerbazione grave di BPCO: tempo alla prima esacerbazioni moderata o grave di BPCO rispetto al placebo nell'arco delle 52 settimane di trattamento
    10. Eventi avversi: numero di eventi avversi ( AEs)/eventi avversi emergenti durante il trattamento (TEAE)
    11. anomalie potenzialmente clinicamente significative (PCSA) in test di laboratorio: Percentuale di pazienti con almeno una incidenza di PCSA
    12.Anticorpi anti-farmaco: Incidenza di Anticorpi ant-farmaco contro dupilumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline to week 12
    2. 3. 4. 8. 9. Baseline to week 52
    5. Baseline to weeks 2, 4, 8, 16, 20, 24, 28, 36, 44, 48
    6. Baseline to weeks 2, 4, 8, 12, 24, 36, 52
    7. Baseline to weeks 2, 4, 8, 12, 16, 24, 28, 36, 44, 52
    10. 11. 12. Baseline through week 64
    1. dal basale alla settimana 12
    2. 3. 4. 8. 9. dal basale alla settimana 52
    5. dal basale alle settimane 2, 4, 8, 16, 20, 24, 28, 36, 44, 48
    6. dal basale alle settimane 2, 4, 8, 12, 24, 36, 52
    7. dal basale alle settimane 2, 4, 8, 12, 16, 24, 28, 36, 44, 52
    10. 11. 12. dal basale fino alla settimana 64
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA89
    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
    Canada
    Chile
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Turkey
    Ukraine
    United States
    Bulgaria
    Czechia
    Denmark
    Finland
    Germany
    Hungary
    Italy
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    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
    Last visit of the last participant (LVLS)
    LVLS
    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 months29
    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 months36
    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: 2381
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 699
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 987
    F.4.2.2In the whole clinical trial 3080
    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 Decision2019-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 09:38:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA