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    Summary
    EudraCT Number:2020-005829-88
    Sponsor's Protocol Code Number:AH0003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 number2020-005829-88
    A.3Full title of the trial
    A PATIENT- AND INVESTIGATOR-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF BEPRANEMAB (UCB0107) IN STUDY PARTICIPANTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE (AD), FOLLOWED BY AN OPEN-LABEL EXTENSION PERIOD
    Studio in cieco per paziente e sperimentatore, controllato con placebo per valutare efficacia, sicurezza e tollerabilità di Bepranemab (UCB0107) nei partecipanti allo studio affetti da Malattia di Alzheimer (AD) da prodromica a lieve, seguito da un periodo di estensione in aperto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studio per verificare efficacia, sicurezza e tollerabilità di bepranemab (UCB0107) in pazienti con deterioramento cognitivo o Malattia di Alzheimer (AD) lieve
    Studio per verificare efficacia, sicurezza e tollerabilità di bepranemab (UCB0107) in pazienti con deterioramento cognitivo o Malattia di Alzheimer (AD) lieve
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberAH0003
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 name18F]GTP1 Positron Emission Tomography (PET) Tracer
    D.3.2Product code [RO6880276]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRO6880276
    D.3.9.3Other descriptive name[18F]GTP1
    D.3.9.4EV Substance CodeSUB198323
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number370
    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 Yes
    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 namebepranemab
    D.3.2Product code [UCB0107]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBepranemab
    D.3.9.1CAS number 2244960-75-4
    D.3.9.2Current sponsor codeUCB0107
    D.3.9.3Other descriptive nameUCB0107
    D.3.9.4EV Substance CodeSUB199722
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    Malattia di Alzheimer
    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
    Investigation of the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD)
    Studio dell’effetto di bepranemab rispetto a (vs) placebo sulla Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) fino alla Settimana 80 nei partecipanti allo studio con Malattia di Alzheimer (AD) da prodromica a lieve
    E.2.2Secondary objectives of the trial
    -Evaluation of the safety and tolerability of bepranemab vs. placebo over 80 weeks in study participants with prodromal or mild Alzheimer's Disease (AD)
    -Investigation of the effect of bepranemab on tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET) imaging in study participants with prodromal or mild AD
    -Investigation of the effect of bepranemab vs placebo on cognitive and functional measures over time in study participants with prodromal or mild AD
    -Characterisation of the pharmacokinetic (PK) of bepranemab following repeated intravenous (iv) administration in study participants with prodromal or mild AD
    -Valutazione di sicurezza e tollerabilità di bepranemab vs placebo nell’arco di 80 settimane nei partecipanti allo studio con Malattia di Alzheimer (AD) da prodromica a lieve
    -Studio dell’effetto di bepranemab sul carico della tau all’interno del cervello misurato mediante tracciante [18F]Genentech tau probe 1 (GTP1) per tomografia a emissione di positroni (PET) nei partecipanti allo studio con AD da prodromica a lieve
    -Studio dell’effetto di bepranemab vs placebo sulle misure cognitive e funzionali nel tempo nei partecipanti allo studio con AD da prodromica a lieve
    -Caratterizzazione della farmacocinetica (PK) di bepranemab a seguito di ripetute somministrazioni per via endovenosa (ev) nei partecipanti allo studio con AD da prodromica a lieve
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 50 to 80 years of age
    - diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
    - a global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDRMemory Box (CDRMB) score =0.5 at Screening and Baseline
    - Score of =85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
    - Mini-Mental State Examination (MMSE) score =20 at Screening
    - Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
    - At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia
    - evidence of cerebral Aß accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aß1-42 ratio assessment
    - età compresa tra 50 e 80 anni
    - diagnosi di deterioramento cognitivo prodromico/lieve (MCI) dovuto alla Malattia di Alzheimer (AD) o AD lieve secondo il National Institute of Aging-Alzheimer's Association (NIA-AA)
    - punteggio globale del Clinical Dementia Rating (CDR) da 0,5 a 1,0 e punteggio del CDRMemory Box (CDRMB) =0,5 allo screening e al basale
    - punteggio per il dominio della memoria differita della Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) =85 allo screening
    - punteggio del Mini-Mental State Examination (MMSE) =20 allo screening
    - il partecipante ha un informatore identificato, con cui mantiene e manterrà contatti sufficienti (minimo 5 ore alla settimana), affinché questi possa fornire informazioni accurate riguardo allo stato cognitivo, funzionale ed emotivo del partecipante, nonché alla sua cura personale
    - almeno 6 anni di istruzione formale dopo i 5 anni di età o esperienza lavorativa che escluda deficit mentali diversi dalla demenza di tipo AD da prodromica a lieve
    - evidenza di accumulo cerebrale di Aß mediante valutazione amiloide positiva eseguita con tomografia a emissione di positroni (PET) oppure valutazione del rapporto pTau181/Aß1-42 nel liquido cefalorachidiano
    E.4Principal exclusion criteria
    - any evidence of a condition that may affect cognition other than AD
    - contraindications to PET imaging
    - Inability to tolerate or contraindication to magnetic resonance imaging
    - any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
    - alcohol or drug abuse within 2 years of screening
    - use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening - previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening
    - chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic
    activitiy
    - received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing
    - qualsiasi evidenza di patologia, diversa da AD, che potrebbe influire sulla sfera cognitiva
    - controindicazioni alla PET
    - incapacità di tollerare o controindicazione alla risonanza magnetica per immagini
    - qualsiasi patologia medica o anomalia che, secondo il parere dello sperimentatore, precluderebbe la partecipazione in sicurezza e il completamento dello studio oppure interferirebbe con le valutazioni e/o l’interpretazione dello studio
    - abuso di alcool o stupefacenti nei 2 anni precedenti lo screening
    - uso di qualsiasi terapia sperimentale negli ultimi 6 mesi (o 5 emivite) precedenti lo screening
    - precedente trattamento con farmaci indicati al trattamento di un disturbo neurodegenerativo (diverso da AD) entro 1 anno dallo screening
    - trattamento giornaliero cronico con antipsicotici atipici, oppiacei o oppioidi, benzodiazepine, barbiturici, ipnotici o qualsiasi farmaco con azione antistaminica o anticolinergica clinicamente significativa che agisce a livello del sistema nervoso centrale
    - trattamento con anticorpi monoclonali (mAbs), citochine, immunoglobuline, o altri prodotti ematici ricevuto nei 3 mesi o 5 emivite (a seconda di quale sia il periodo più lungo) precedenti la prima somministrazione
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
    1. Variazione dal basale alla Settimana 80 nel punteggio totale del Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From from Baseline to Week 80
    1. Dal basale alla Settimana 80
    E.5.2Secondary end point(s)
    1. Incidence of treatment-emergent adverse events (TEAEs)
    2. Incidence of treatment-emergent serious adverse events (TESAEs)
    3. Incidence of TEAEs leading to discontinuation or death
    4. Incidence of Drug-related TEAEs
    5. Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
    6. Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET)
    7. Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
    8. Change from Baseline to Week 56 and Week 80 in AmsterdamInstrumental Activities of Daily Living (A-iADL)
    9. Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score
    10. Serum concentrations of bepranemab over the 80-week Double-blind Treatment Period
    1. Incidenza di eventi avversi emergenti dal trattamento (TEAE)
    2. Incidenza di eventi avversi seri emergenti dal trattamento (TESAE)
    3. Incidenza dei TEAE che portano a interruzione o decesso
    4. Incidenza dei TEAE correlati al farmaco
    5. Variazione rispetto al basale nell’ideazione suicidaria e nel comportamento valutato mediante la scala di valutazione della gravità della suicidalità della Columbia University (C-SSRS)
    6. Variazione dal basale alla Settimana 56 e alla Settimana 80 negli indici del carico della tau all’interno del cervello misurato mediante tracciante [18F]Genentech tau probe 1 (GTP1) per tomografia a emissione di positroni (PET)
    7. Variazione dal basale alla Settimana 56 e alla Settimana 80 nella sottoscala Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
    8. Variazioni dal basale alla Settimana 56 e alla Settimana 80 nell’Amsterdam-Instrumental Activities of Daily Living (A-iADL)
    9. Variazione dal basale alla Settimana 56 e alla Settimana 80 nel punteggio totale del Mini-Mental State Examination (MMSE)
    10. Concentrazioni sieriche di bepranemab durante l’intero periodo di trattamento in doppio cieco di 80 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 4: From Baseline to the Safety Follow-Up (Week 152)
    6 - 9: From from Baseline to Week 56 and Week 80
    5 + 10: From from Baseline to Week 80
    1 - 4: Dal basale al follow-up di sicurezza (Settimana 152)
    6 - 9: Dal basale alla Settimana 56 e alla Settimana 80
    5 + 10: Dal basale alla Settimana 80
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability; Immunogenicity
    Tollerabilità; immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    E.8.1.7.1Other trial design description
    Periodo di trattamento in doppio cieco seguito da un periodo di estensione del trattamento in aperto
    Double-blind Treatment Period followed by Open-label Extension Treatment Period
    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 trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Canada
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 250
    F.4.2.2In the whole clinical trial 450
    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 Decision2021-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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