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   43974   clinical trials with a EudraCT protocol, of which   7312   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:2021-004135-89
    Sponsor's Protocol Code Number:D516FC00001
    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:2021-12-30
    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 number2021-004135-89
    A.3Full title of the trial
    Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation positive Stage IA2-IA3 Nonsmall Cell Lung Cancer, following Complete Tumour Resection
    Studio internazionale di fase III, in doppio cieco, randomizzato, controllato verso placebo, volto a valutare l’efficacia e la sicurezza di osimertinib in adiuvante verso placebo, in pazienti con carcinoma polmonare non a piccole cellule di stadio IA2-IA3 positivo alla mutazione di EGFR, a seguito di resezione completa del tumore (ADAURA2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A late stage clinical trial to investigate the efficacy and safety of Osimertinib versus Placebo in patients with stage IA2-IA3 non-small cell lung cancer, following complete tumour resection.
    Studio di fase avanzata per valutare l'efficacia e la sicurezza di Osimertinib verso placebo in pazienti con carcinoma polmonare non a piccole cellule di stadio IA2-IA3 dopo resezione completa del tumore
    A.3.2Name or abbreviated title of the trial where available
    ADAURA2
    ADAURA2
    A.4.1Sponsor's protocol code numberD516FC00001
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZenecaAB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Centre
    B.5.3 Address:
    B.5.3.1Street Address1800 Concorde Pike
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+187772409479
    B.5.6E-mailinformation.centre@astrazeneca.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 Yes
    D.2.1.1.1Trade name Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOsimertinib 40mg
    D.3.2Product code [AZD9291]
    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 INNosimertinib
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.1.1.1Trade name Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOsimertinib 80 mg
    D.3.2Product code [AZD9291]
    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 INNosimertinib
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 placeboFilm-coated tablet
    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
    Stage IA2-IA3 non-small cell lung carcinoma, with EGFR mutation type (Ex19del, L858R), following complete tumour resection.
    Carcinoma polmonare non a piccole cellule in stadio IA2-IA3 con mutazioni di EGFR (Ex19del, L858R), a seguito di resezione completa
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called non-small cell lung cancer (NSCLC) stage IA2-IA3 with EGFR mutations positive after complete surgical removal of a tumour between 1 and 3 centimetres.
    Tipo specifico di carcinoma polmonare detto carcinoma polmonare non a piccole cellule (NSCLC) di stadio IA2-IA3, positivo per mutazioni di EGFR, dopo resezione completa un tumore di 1-3 centimetri
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of osimertinib compared to placebo as measured by disease-free survival in participants in the high-risk statum.
    Determinare l’efficacia di osimertinib rispetto al placebo tramite la valutazione della sopravvivenza libera da malattia (DFS) nei partecipanti ad alto rischio.
    E.2.2Secondary objectives of the trial
    1. To demonstrate the effectiveness of osimertinib versus placebo by assessment of disease-free survival (DFS) in the overall population.
    2. To demonstrate the effectiveness of osimertinib versus placebo by assessment of overall survival (OS) in participants in both the high-risk stratum and the overall population.
    3. To assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population.
    4. To assess the effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population.
    5. To characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population.
    6. To assess the safety and tolerability profile of osimertinib versus placebo in the overall population.
    1. Dimostrare l’efficacia di osimertinib rispetto al placebo mediante la valutazione della sopravvivenza libera da malattia (DFS) nella popolazione complessiva.
    2. Dimostrare l’efficacia di osimertinib rispetto al placebo mediante la valutazione della sopravvivenza globale (OS) sia nello strato ad alto rischio sia nella popolazione complessiva.
    3. Valutare l’impatto di osimertinib rispetto al placebo sulla funzionalità fisica sia nello strato ad alto rischio sia nella popolazione complessiva.
    4. Valutare l’efficacia di osimertinib rispetto al placebo mediante la valutazione della sopravvivenza libera da malattia (DFS) del sistema nervoso centrale sia nello strato ad alto rischio sia nella popolazione complessiva.
    5. Caratterizzare la farmacocinetica di osimertinib e dei suoi metaboliti (AZ13575104 [AZ5104]) nella popolazione complessiva.
    6. Valutare il profilo di sicurezza e tollerabilità di osimertinib rispetto al placebo nella popolazione complessiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least >= 18 years.
    2. NSCLC, of non-squamous histology.
    3. Stage IA2 or IA3 disease, based on TNM8 classification.
    4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, segmentectomy or sleeve resection.
    5. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
    6. World Health Organization performance status of 0 or 1.
    7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
    8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R).
    9. Minimum life expectancy of > 6 months.
    10. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.
    1. Maschi o femmine con almeno >= 18 anni
    2. NSCLC a istologia non squamosa
    3. Malattia in stadio IA2 o IA3, in base alla classificazione TNM8
    4. Resezione chirurgica completa (R0) del NSCLC primario mediante lobectomia, segmentectomia o “resezione a manicotto” (sleeve resection)
    5. Completa recupero dall’intervento chirurgico al tempo della randomizzazione. L’intervento di studio non può iniziare entro 4 settimane dopo l’intervento chirurgico. Non devono trascorrere più di 12 settimane tra l’intervento chirurgico e la randomizzazione dei partecipanti
    6. Performance status della World Health Organization pari a 0 o 1
    7. I campioni tumorali dovranno essere inviati per la valutazione patologica centralizzata dei fattori di rischio e per la valutazione delle mutazioni EGFR prima della randomizzazione
    8. Un tumore con una delle 2 mutazioni di EGFR (Ex19del, L858R)
    9. Aspettativa di vita minima di >6 mesi
    10. Le donne devono utilizzare misure anti-contraccettive altamente efficaci e devono avere un test di gravidanza negativo prima dell’inizio della somministrazione, se in età fertile, o avere prove di non poter avere figli. Gli uomini devono essere disponibili a usare metodi di contraccettivi di barriera
    E.4Principal exclusion criteria
    1. Mixed small cell and non-small cell cancer history.
    2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
    3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
    4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease = 5 years before the first dose of study intervention and of low potential risk for recurrence.
    5. Any of the following cardiac criteria:
    - Mean resting QTc interval > 470 ms, obtained from triplicate ECGs performed at screening,
    - Any abnormalities in rhythm, conduction, or morphology of resting ECG,
    - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
    6. History of interstitial lung disease.
    7. Inadequate bone marrow reserve or organ function.
    8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
    9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
    10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
    11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.
    1. Storia di cancro a piccole cellule miste e non a piccole cellule
    2. Partecipanti con resezione incompleta (R1/R2) o che si sono sottoposti a pneumonectomia, bilobectomia e resezione a cuneo.
    3. Qualsiasi evidenza di malattie sistemiche gravi o incontrollate, incluse ipertensione incontrollata e diatesi emorragica attiva, o infezioni attive, tra cui epatite B, epatite C e HIV.
    4. Anamnesi di un altro tumore maligno, a eccezione di tumori trattati con intento curativo senza malattia attiva conosciuta da = 5 anni prima della prima dose dello studio e basso rischio potenziale di ricorrenza.
    5. Qualsiasi dei seguenti criteri cardiaci:
    - intervallo QT a riposo medio > 470 ms, ottenuto da ECG in triplicato effettuati allo screaning,
    - qualsiasi anormalità di ritmo, conduzione o morfologia dell’ECG a riposo,
    - qualsiasi fattore che aumenta il rischio di estensione del QTc o il rischio di episodi aritmici.
    6. Storia clinica di malattia interstiziale polmonare.
    7. "Riserva" di midollo osseo o funzionalità degli organi inadeguati.
    8. Qualsiasi tossicità non risolta da prima della terapia, maggiore del grado 1 della CTCAE al tempo dell’inizio dell’intervento in studio.
    9. Precedenti trattamenti con qualsiasi terapia anti-cancro per il NSCLC (inclusi chemioterapia, radioterapia, immunoterapia e EGFR-TKIs).
    10. Chirurgia maggiore o lesione traumatica significante nelle 4 settimane della prima dose dell’intervento in studio.
    11. Partecipanti che attualmente ricevono medicazioni o supplementi a base di erbe riconosciuti essere forti induttori di CYP3A4.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (DFS) in the high-risk stratum by investigators' assessment.
    Sopravvivenza libera da malattia (DFS) nei partecipanti ad alto rischio sula base della valutazione dello sperimentatore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization until recurrence or death (by any cause in the absence of recurrence). Initial analysis in 2027.
    Dalla randomizzazione fino a recidiva o morte (per qualsiasi causa in assenza di recidiva). Analisi iniziale nel 2027.
    E.5.2Secondary end point(s)
    - Disease free survival (DFS) in the overall population by investigator's assessment.
    - Disease free survival (DFS) in both the high-risk stratum and overall population.
    - Overall survival (OS) in participants in both the high-risk stratum and overall population.
    - Impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population.
    - Effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population.
    - Characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population.
    - Safety and tolerability profile of osimertinib versus placebo in the overall population.
    - Sopravvivenza libera da malattia (DFS) nella popolazione complessiva basata sulla valutazione dello sperimentatore.
    - Sopravvivenza libera da malattia (DFS) sia nello strato ad alto rischio sia nella popolazione complessiva.
    - Sopravvivenza globale (OS) sia nello strato ad alto rischio sia nella popolazione complessiva.
    - Impatto di osimertinib rispetto al placebo sulla funzionalità fisica sia nello strato ad alto rischio sia nella popolazione complessiva.
    - Efficacia di osimertinib rispetto al placebo mediante la valutazione della sopravvivenza libera da malattia (DFS) del sistema nervoso centrale sia nello strato ad alto rischio sia nella popolazione complessiva.
    - Caratterizzare la farmacocinetica di osimertinib e dei suoi metaboliti (AZ13575104 [AZ5104]) nella popolazione complessiva.
    - Profilo di sicurezza e tollerabilità di osimertinib rispetto al placebo nella popolazione complessiva.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial.
    Per tutta la durata dello 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Singapore
    Thailand
    Turkey
    Argentina
    Austria
    Brazil
    Canada
    China
    Germany
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    Vietnam
    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
    The last visit of the last patient undergoing the study
    Ultima visita dell'utimo paziente che partecipa al trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
    Per pazienti di età inferiore a 20 anni in Giappone deve essere ottenuto il consenso del paziente o di un rappresentante legalmente accettabile
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 380
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated in accordance with the local standard of care
    I pazienti verranno trattati sulla base di quanto previsto dalla standard of care locale
    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 Decision2022-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-23
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA