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    Summary
    EudraCT Number:2021-002537-41
    Sponsor's Protocol Code Number:20170104
    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:2022-01-26
    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 number2021-002537-41
    A.3Full title of the trial
    A Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis.
    A Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis
    A Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number20170104
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVIA E. TAZZOLI, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@amgen.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 nameEfavaleukin Alfa
    D.3.2Product code [AMG 592]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNEFAVALEUKIN ALFA
    D.3.9.2Current sponsor codeAMG 592
    D.3.9.4EV Substance CodeSUB195522
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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/infusion
    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
    Moderate to Severe Active Ulcerative Colitis
    Colite Ulcerosa Attiva da moderata a severa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of evavaleukin alfa on induction of clinical remission
    Valutare l'effetto di efavaleukin alfa sull'induzione della remissione clinica
    E.2.2Secondary objectives of the trial
    To evaluate the effect of efavaleukin alfa on induction of clinical response
    - To evaluate the effect of efavaleukin alfa as induction therapy on endoscopic remission
    - To evaluate the effect of efavaleukin alfa as induction therapy on mucosal healing
    - To evaluate the effect of efavaleukin alfa as induction therapy on change in histological score
    - To evaluate the safety and tolerability of efavaleukin alfa
    - To evaluate efavaleukin alfa immunogenicity
    Valutare l'effetto di efavaleukin alfa sull'induzione della risposta clinica
    - Valutare l'effetto di efavaleukina alfa come terapia di induzione sulla remissione endoscopica
    - Valutare l'effetto di efavaleukina alfa come terapia di induzione sulla guarigione della mucosa
    - Valutare l'effetto di efavaleukina alfa come terapia di induzione sul cambiamento del punteggio istologico
    - Valutare la sicurezza e la tollerabilità di efavaleukin alfa
    - Valutare l'immunogenicità di efavaleukin alfa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent prior to initiation of any study specific activities or procedures.
    102 Aged from 18 years to 80 years at screening visit, except in South Korea where from age 19 years to 80 years at screening visit.
    103 Diagnosis of UC established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
    104 Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read rectosigmoidoscopy endoscopic subscore at least 2 and no subscore less than 1 prior to day 1.
    105 Has documentation of A surveillance colonoscopy within 12 months of day 1 visit for subjects with pancolitis of at least 8 years duration, or subjects with left-sided colitis of over 12 years duration, or subjects with primary sclerosing cholangitis.
    For all other subjects, up-to-date colorectal cancer surveillance (performed according to local standard). Subjects who do not have a
    colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study, at the discretion of the investigator.
    106 Subjects must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, JAK-inhibitor).
    Conventional therapy failed subjects:
    - Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone (or equivalent) at doses of at least 30 mg/day for a minimum of 2 weeks; or
    corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids
    - History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with
    corticosteroid treatment)
    - Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine or 6-mercaptopurine, or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing
    - History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-TNF antibody, anti-integrin antibody, or IL-12/23 antagonists) that is indicated for the treatment of UC
    Biologic or targeted small molecule therapy failed subjects: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors).

    Please refer to the study protocol for the full list of Inclusion criteria
    101 Il soggetto ha fornito il consenso informato prima dell'inizio di qualsiasi attività o procedura specifica dello studio.
    102 Età compresa tra i 18 e gli 80 anni alla visita di screening, eccetto in Corea del Sud dove dai 19 agli 80 anni alla visita di screening.
    103 Diagnosi di UC stabilita almeno 3 mesi prima dell'arruolamento mediante prove cliniche ed endoscopiche e confermata da un rapporto istopatologico.
    104 UC da moderatamente a gravemente attiva come definita da un punteggio Mayo modificato da 5 a 9, con un subscore endoscopico letto centralmente in rettosigmoidoscopia di almeno 2 e nessun subscore inferiore a 1 prima del giorno 1.
    105 Ha la documentazione di una colonscopia di sorveglianza entro 12 mesi dalla visita del giorno 1 per i soggetti con pancolite di almeno 8 anni di durata, o soggetti con colite sinistra di oltre 12 anni di durata, o soggetti con colangite sclerosante primaria.
    Per tutti gli altri soggetti, sorveglianza aggiornata del cancro colorettale (eseguita secondo lo standard locale). I soggetti che non hanno un rapporto di colonscopia disponibile nella documentazione di origine avranno una colonscopia invece della rettosigmoidoscopia eseguita come endoscopia di screening per lo studio, a discrezione dello sperimentatore.
    106 I soggetti devono aver dimostrato una risposta inadeguata, una perdita di risposta o un'intolleranza ad almeno 1 terapia convenzionale, una terapia biologica o una terapia mirata con piccole molecole (cioè un inibitore della JAK).
    La terapia convenzionale ha fallito nei soggetti:
    - Corticosteroidi (colite refrattaria ai corticosteroidi, definita come segni e/o sintomi di UC attiva nonostante prednisone orale (o equivalente) a dosi di almeno 30 mg/giorno per un minimo di 2 settimane; o
    colite corticosteroidea dipendente, definita come: incapacità di ridurre i corticosteroidi al di sotto dell'equivalente di prednisone 10 mg/giorno entro 3 mesi dall'inizio dei corticosteroidi senza un ritorno di segni e/o sintomi di UC attiva; o una ricaduta entro 3 mesi dal completamento di un ciclo di corticosteroidi
    - Storia di intolleranza ai corticosteroidi (inclusi, ma non limitati a, sindrome di Cushing, osteopenia/osteoporosi, iperglicemia o effetti collaterali neuropsichiatrici, inclusa l'insonnia, associati a
    trattamento con corticosteroidi)
    - Immunomodulatori: segni e/o sintomi di malattia persistentemente attiva nonostante almeno 3 mesi di trattamento con uno dei seguenti a dosi approvate localmente: azatioprina orale o 6-mercaptopurina, o azatioprina orale o 6-mercatopurina entro un range terapeutico come giudicato dal test dei metaboliti della tioguanina, o una combinazione di una tiopurina e allopurinolo entro un range terapeutico come giudicato dal test dei metaboliti della tioguanina
    - Storia di intolleranza ad almeno 1 immunomodulatore (incluso ma non limitato a nausea/vomito, dolore addominale, pancreatite, anomalie dei test di funzionalità epatica e linfopenia) e non hanno fallito né dimostrato intolleranza ad un farmaco biologico (anticorpo anti-TNF, anticorpo anti-integrina o antagonisti IL-12/23) che è indicato per il trattamento della UC
    Soggetti che hanno fallito la terapia biologica o con piccole molecole mirate: coloro che hanno dimostrato una risposta inadeguata o una perdita di risposta o un'intolleranza alla terapia biologica per la UC (per esempio, anticorpi anti-TNF o antagonisti IL-12/23, anticorpi anti-integrina) o a piccole molecole mirate (per esempio, inibitori JAK).

    Si prega di fare riferimento al protocollo di studio per la lista completa dei criteri di inclusione
    E.4Principal exclusion criteria
    201 Diagnosis of Crohn's disease, inflammatory bowel diseaseunclassified, microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease.
    202 Disease limited to the rectum.
    203 Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
    204 Previous bowel resection or intestinal or intra-abdominal surgery. Have had extensive surgery for UC, or are likely to require surgery for the treatment of UC during the study. Subjects who have had limited surgery for UC may be allowed in the study, if this does not affect the assessment of efficacy. Discussion with the sponsor must occur prior to screening of such subjects.
    Have had any small bowel or colonic surgery within 6 months of day 1.
    Have had any nonintestinal intra-abdominal surgery within 3 months of day 1.
    205 Adenoma and dysplasia exclusion criteria:
    Any current sporadic adenoma without dysplasia that has not been removed. Once completely removed, the subject is eligible for study.
    Dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia-associated lesions or masses will be managed as follows:
    Any history or current evidence of high-grade dysplasia.
    Any history or current evidence of dysplasia occurring in flat mucosa.
    This includes histopathology reporting indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia.
    Any history or current evidence of a nonadenoma-like dysplasia-associated lesions or masses, with or without evidence of dysplasia.
    Any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been removed. Once completely removed, the patient is eligible for the study.
    206 Stool positive for Clostridium difficile toxin at screening and other enteric pathogens including but not limited to ova, parasites, Campylobacter, salmonella, shigella, E coli 0157:H7, and Yersinia enterocolitica.
    207 History or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia Suicide Severity Rating Scale (C-SSRS) at screening
    208 Active infection for which anti-infectives were indicated within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
    209 Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.

    Please refer to the study protocol for the full list of Inclusion criteria
    201 Diagnosi di malattia di Crohn, malattia infiammatoria intestinale non classificata, colite microscopica, colite ischemica, o risultati clinici suggestivi di malattia di Crohn.
    202 Malattia limitata al retto.
    203 Evidenza di megacolon tossico, colite fulminante, ascesso intra-addominale o stenosi/stenosi nell'intestino tenue o nel colon.
    204 Precedente resezione intestinale o chirurgia intestinale o intra-addominale. Hanno avuto un intervento chirurgico esteso per la UC, o è probabile che abbiano bisogno di un intervento chirurgico per il trattamento della UC durante lo studio. I soggetti che hanno subito un intervento chirurgico limitato per la UC possono essere ammessi allo studio, se questo non influisce sulla valutazione dell'efficacia. La discussione con lo sponsor deve avvenire prima dello screening di tali soggetti.
    Aver subito un qualsiasi intervento chirurgico all'intestino tenue o al colon entro 6 mesi dal giorno 1.
    Aver subito un qualsiasi intervento chirurgico intra-addominale non intestinale entro 3 mesi dal giorno 1.
    205 Criteri di esclusione per adenoma e displasia:
    Qualsiasi adenoma sporadico attuale senza displasia che non sia stato rimosso. Una volta completamente rimosso, il soggetto è eleggibile per lo studio.
    La displasia che si verifica nella mucosa piatta, gli adenomi sporadici contenenti displasia e le lesioni o masse associate alla displasia saranno gestite come segue:
    Qualsiasi storia o evidenza attuale di displasia di alto grado.
    Qualsiasi storia o evidenza attuale di displasia che si verifica nella mucosa piatta.
    Questo include l'istopatologia che riporta una displasia indefinita, una displasia di basso grado e una displasia di alto grado.
    Qualsiasi storia o evidenza attuale di lesioni o masse non associate ad adenoma, con o senza evidenza di displasia.
    Qualsiasi attuale adenoma sporadico contenente displasia o qualsiasi attuale lesione o massa associata a displasia simile all'adenoma che non sia stata rimossa. Una volta completamente rimosso, il paziente è eleggibile per lo studio.
    206 Feci positive per la tossina del Clostridium difficile allo screening e altri patogeni enterici inclusi, ma non limitati a ovuli, parassiti, Campylobacter, salmonella, shigella, E coli 0157:H7, e Yersinia enterocolitica.
    207 Storia o evidenza di ideazione suicida (gravità di 4 o 5) o qualsiasi comportamento suicida basato su una valutazione con la Columbia Suicide Severity Rating Scale (C-SSRS) allo screening
    208 Infezione attiva per la quale sono stati indicati anti-infettivi nelle 4 settimane precedenti la visita di screening OPPURE presenza di un'infezione grave, definita come richiedente l'ospedalizzazione o anti-infettivi per via endovenosa nelle 8 settimane precedenti la visita di screening.
    209 Tubercolosi attiva o tubercolosi latente senza storia documentata di trattamento adeguato secondo lo standard di cura locale.

    Si prega di fare riferimento al protocollo di studio per la lista completa dei criteri di inclusione
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission at week 12
    Remissione clinica alla settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    Clinical response at week 12
    Endoscopic remission at week 12
    Symptomatic remission at week 12
    Combined endoscopic remission and histologic remission of the colon tissue at week 12
    Change from baseline in histological score at week 12 as measured by Geboes score
    Treatment-emergent adverse events
    Risposta clinica alla settimana 12
    Remissione endoscopica alla settimana 12
    Remissione sintomatica alla settimana 12
    Remissione endoscopica combinata e remissione istologica del tessuto del colon alla settimana 12
    Cambiamento dal basale nel punteggio istologico alla settimana 12 come misurato dal punteggio Geboes
    Eventi avversi emergenti dal trattamento
    Anticorpi anti-efavaleuchina alfa e cross-reattività con IL-2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Austria
    Bulgaria
    Canada
    Czechia
    Denmark
    Finland
    Germany
    Italy
    Japan
    Korea, Democratic People's Republic of
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    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
    End of long-term treatment (Long-term extension is additional 40 week +6 week follow-up)
    Termine della fase di trattamento a lungo termine (l'estensione a lungo termine è di ulteriori 40 settimane +6 settimane di follow-up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 158
    F.4.2.2In the whole clinical trial 320
    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)
    6 week follow up
    Follow-up a 6 settimane
    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 Decision2021-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-21
    P. End of Trial
    P.End of Trial StatusOngoing
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