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    Summary
    EudraCT Number:2020-004864-25
    Sponsor's Protocol Code Number:NN6535-4725
    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:2021-06-08
    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 number2020-004864-25
    A.3Full title of the trial
    A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE plus)
    Studio clinico randomizzato, in doppio cieco, controllato con placebo, per valutare l’effetto e la sicurezza di semaglutide orale in soggetti affetti da morbo di Alzheimer in fase iniziale (EVOKE plus)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study investigating semaglutide in people with early Alzheimer's disease (EVOKE plus)
    Studio clinico per valutare semaglutide in persone affette da morbo di Alzheimer in fase iniziale (EVOKE plus)
    A.3.2Name or abbreviated title of the trial where available
    EVOKE plus
    EVOKE plus
    A.4.1Sponsor's protocol code numberNN6535-4725
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-2920
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Transparency (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 Rybelsus
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namesemaglutide
    D.3.2Product code [NN6535]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.2Current sponsor codeNon applicabile
    D.3.9.3Other descriptive namesemaglutide
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.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 Rybelsus®
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 namesemaglutide
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namesemaglutide
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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.IMP: 3
    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 Rybelsus
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namesemaglutide
    D.3.2Product code [semaglutide]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namesemaglutide
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer's type.
    Decadimento cognitivo lieve (MCI) o demenza lieve, entrambi del tipo Alzheimer.
    E.1.1.1Medical condition in easily understood language
    Early Alzheimer's disease.
    Morbo di Alzheimer in fase iniziale.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer's type.
    Confermare la superiorità di semaglutide orale in confronto al placebo sulla variazione nella capacità cognitiva e nella funzione in soggetti affetti da MCI o demenza lieve, entrambi del tipo Alzheimer.
    E.2.2Secondary objectives of the trial
    To compare the effects of oral semaglutide versus placebo in subjects with MCI or mild dementia, both of the Alzheimer's type, on:
    - progression to dementia among subjects with MCI at baseline
    - neuropsychiatric symptoms
    - safety and tolerability
    - quality of life
    Confrontare gli effetti di semaglutide orale in confronto al placebo nei soggetti affetti da MCI o demenza lieve, entrambi del tipo Alzheimer su:
    -progressione verso la demenza tra i soggetti affetti da MCI al basale
    -sintomi neuropsichiatrici
    -sicurezza e tollerabilità
    -qualità della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
    - MCI or mild dementia of the Alzheimer's type according to the National Institute of Aging-Alzheimer's Association (NIA-AA) 2018 criteria.
    - Clinical Dementia Rating (CDR) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0.
    - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) delayed memory index score of less than or equal to 85.
    - Mini-Mental State Examination (MMSE) greater than or equal to 22.
    - Amyloid positivity established with either amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) Aß1-42.
    - If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors or memantine) the dose must have been stable for at least 3 months prior to screening and should not be changed during the trial unless medically necessary
    - Maschi o femmine, età 55-85 anni (estremi compresi) al momento della firma del modulo di consenso informato.
    - MCI o demenza lieve del tipo Alzheimer secondo i criteri del National Institute of Aging-Alzheimer's Association (NIA-AA) 2018.
    - Punteggio Clinical Dementia Rating (CDR) globale pari a 0,5 e CDR pari a 0,5 o superiore in almeno una delle tre attività strumentali della vita quotidiana (cura della persona, casa e hobby, affari comunitari) Oppure Punteggio globale CDR pari a 1,0
    - Punteggio dell’indice di memoria ritardato Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) minore o uguale a 85
    - Mini-Mental State Examination (MMSE) maggiore o uguale a 22
    - Positività all’amiloide stabilita con tomografia ad emissione di positroni (PET) amiloide o con fluido cerebrospinale (CSF) Aß1-42
    - Se si riceve un trattamento approvato per il morbo di Alzheimer (come gli inibitori dell’acetilcolinesterasi o la memantina), la dose deve essere rimasta stabile per almeno 3 mesi prima dello screening e non deve essere modificata durante lo studio, a meno che non sia necessario da un punto di vista medico.
    E.4Principal exclusion criteria
    - Brain magnetic resonance imaging (MRI) (or computerised tomography (CT)) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by central read (e.g. cerebral large vessel disease [large vessel (cortical) infarcts greater than 10 mm in diameter], prior macro-haemorrhage [ greater than 1 cm^3], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus).
    - Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read.
    - Evidence of a relevant neurological disorder other than mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, human immunodeficiency virus (HIV), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits.
    - Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM–5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A subject with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the trial per investigator's judgement.
    - Malattia strutturale, clinicamente significativa del Sistema Nervoso Centrale (CNS) evidenziata da Risonanza Magnetica Nucleare (MRI) (o tomografia computerizzata - CT), confermata da lettura centrale (ad es. malattia cerebrale dei grandi vasi [infarti dei grandi vasi (corticali) maggiore di 10 mm di diametro], precedente macro-emorragia [maggiore di 1 cm3], malformazioni vascolari cerebrali, emosiderosi corticale, anerurismi intracranici, tumori intracranici, alterazioni attribuibili a idrocefalo normoteso).
    - Infarti strategici definiti come infarti talamici lacunari bilaterali e infarti talamici paramediani singoli evidenziati da MRI cerebrale (o CT) confermati da lettura centrale.
    - Evidenze di un disturbo neurologico rilevante diverso dal decadimento cognitivo lieve (MCI) o dalla demenza lieve di tipo Alzheimer allo screening, come a titolo di esempio, ma non limitato a morbo di Parkinson, malattia dei corpi di Lewy, demenza frontotemporale di qualsiasi tipo, malattia di Huntington, sclerosi laterale amiotrofica, sclerosi multipla, lupus eritematoso sistemico, paralisi sopranucleare progressiva, neurosifilide, virus umano dell'immunodeficienza (HIV), disturbi dell’apprendimento, disabilità intellettiva, danno cerebrale ipossico, o trauma cranico significativo con perdita di conoscenza che ha portato a deficit cognitivi persistenti.
    - Evidenze di un disturbo psichiatrico clinicamente rilevante o instabile, in base ai criteri del Manuale diagnostico e statistico dei disturbi mentali (Diagnostic and Statistical Manual of Mental Disorders, DSM–5), compresa la schizofrenia o un altro disturbo psicotico o bipolare. Un soggetto con una storia di depressione grave, che non ha avuto un episodio negli ultimi 24 mesi prima del giorno dello screening ed è considerato in remissione, o la cui depressione è controllata con il trattamento, può essere incluso nello studio secondo il giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) score
    Variazione nella valutazione clinica della demenza - Somma del punteggio delle caselle (Clinical Dementia Rating – Sum of Boxes, CDR-SB)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (week 0) to week 104
    Dal basale (settimana 0) alla settimana 104
    E.5.2Secondary end point(s)
    1. Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for mild cognitive impairment (MCI) (ADCS-ADL-MCI)
    score
    2. Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline
    3. Change in the 13-item Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog-13) score
    4. Change in the Montreal Cognitive Assessment (MoCA) score
    5. Change in the Alzheimer's Disease Composite Score (ADCOMS)
    6. Change in the Mini-Mental State Examination (MMSE) score
    7. Change in the 10-item Neuropsychiatric Inventory (NPI) score
    8. Time to progression in disease stage based on global CDR score
    9. Number of treatment emergent adverse events (TEAEs)
    10. Change in high sensitivity C-reactive protein level
    11. Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and all-cause death
    12. Time to first occurrence of stroke
    13. Change in the EQ-5D-5L proxy score
    Extension phase
    14. Change in the CDR-SB score
    15. Change in the ADCS-ADL-MCI total score
    16. Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline
    1. Variazione nel punteggio della scala Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale per il decadimento cognitivo lieve (MCI) (ADCS-ADL-MCI)
    2. Tempo di progressione verso la demenza (CDR globale magiore o uguale a 1,0) tra i soggetti con MCI (CDR globale = 0,5) al basale
    3. Variazione del punteggio nella scala 13-item Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog-13)
    4. Variazione nel punteggio del test Montreal Cognitive Assessment (MoCA)
    5. Variazione nel punteggio Alzheimer’s Disease Composite Score (ADCOMS)
    6. Variazione nel punteggio del Mini-Mental State Examination (MMSE)
    7. Variazione nel punteggio 10-item Neuropsychiatric Inventory (NPI)
    8. Tempo di progressione negli stadi della malattia in base al punteggio CDR globale
    9. Numero degli eventi avversi emergenti dal trattamento (Treatment Emergent Adverse Events, TEAEs)
    10. Variazione nel livello di proteina C-reattiva
    11. Tempo prima del primo evento avverso cardiovascolare maggiore (Major Adverse Cardiovascular Event, MACE), tra cui infarto del miocardico non fatale, ictus non fatale e decesso per qualsiasi causa
    12. Tempo prima del primo episodio di ictus
    13. Variazione del punteggio della scala EQ-5D-5L
    Fase di estensione
    14. Variazione nel punteggio CDR-SB
    15. Variazione nel punteggio totale ADCS-ADL-MCI
    16. Tempo di progressione verso la demenza (CDR globale maggiore o uguale a 1,0) tra i soggetti con MCI (CDR globale = 0,5) al basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-13 From baseline (week 0) to week 104
    14.-16. From baseline (week 0) to week 156
    1.-13 Dal basale (settimana 0) alla settimana 104
    14.-16. Dal basale (settimana 0) alla settimana 156
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 EEA152
    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
    Australia
    Brazil
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days28
    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: 276
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1564
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 624
    F.4.2.2In the whole clinical trial 1840
    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 Decision2021-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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