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    Summary
    EudraCT Number:2020-000645-14
    Sponsor's Protocol Code Number:EFC16035
    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:2021-06-15
    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 number2020-000645-14
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
    Studio di Fase 3, randomizzato, in doppio cieco, di efficacia e sicurezza, che confronta SAR442168 con placebo in partecipanti affetti da sclerosi multipla progressiva primaria (PERSEUS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Primary Progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)
    Studio sull’inibitore di BTK SAR442168 nella sclerosi multipla primariamente progressiva (SMPP) (PERSEUS)
    A.3.2Name or abbreviated title of the trial where available
    PERSEUS
    PERSEUS
    A.4.1Sponsor's protocol code numberEFC16035
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1238-1318
    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 SponsorGENZYME CORPORATION
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.R.L.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO, 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code [SAR442168]
    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.3.9.1CAS number 1971920-73-6
    D.3.9.2Current sponsor codeSAR442168
    D.3.9.3Other descriptive namePRN2246
    D.3.9.4EV Substance CodeSUB195428
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Progressive Multiple Sclerosis
    Sclerosi multipla progressiva primaria
    E.1.1.1Medical condition in easily understood language
    Primary Progressive Multiple Sclerosis
    Sclerosi multipla progressiva primaria
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in Primary Progressive Multiple Sclerosis (PPMS).
    Determinare l’efficacia di SAR442168 rispetto al placebo nel ritardare la progressione della disabilità nella Sclerosi multipla progressiva primaria (SMPP).
    E.2.2Secondary objectives of the trial
    To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life
    To evaluate safety and tolerability of SAR442168
    To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety
    To evaluate pharmacodynamics of SAR442168
    Valutare l’efficacia di SAR442168 rispetto al placebo in termini di endpoint clinici, lesioni alla RM, capacità cognitive, funzione fisica e qualità della vita
    Valutare la sicurezza e la tollerabilità di SAR442168
    Valutare la farmacocinetica (PK) di SAR442168 in SMPP e il suo rapporto con efficacia e sicurezza
    Valutare la farmacodinamica (PD) di SAR442168
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 to 55 years of age inclusive
    - Diagnosis of PPMS according to the 2017 McDonald criteria
    - Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
    - Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
    - Contraceptive use consistent with local regulations for individuals participating in clinical studies
    - Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    - Is not a woman of child bearing potential (WOCBP)
    OR
    - Is a WOCBP and agrees to use an acceptable contraceptive method
    -includere pazienti tra i 18 e 55 anni
    - Diagnosi di SMPP in conformità ai criteri di McDonald modificati del 2017
    - Punteggio EDSS allo screening compreso tra 2,0 a 6,5 punti, inclusi.
    - Positività nel fluido cerebrospinale di bande oligoclonali e/o indice IgG elevato durante lo screening o in base a precedente valutazione anamnestica
    - Utilizzo di contraccettivi deve essere in linea con le normative locali riguardanti i metodi di contraccezione per coloro che partecipano agli studi clinici
    -una partecipante di sesso femminile è elegibile se non è incinta o in allattamento e almeno una dei due condizioni seguenti sono applicabili:
    - non è una donna in età fertile (WOCBP) o è WOCBP ed acconsente ad utilizzare un metodo contraccettivo accettabile
    E.4Principal exclusion criteria
    - Participant has conditions that would adversely affect study participation such as short life expectancy
    - History of organ transplant.
    - Evidence of infection with human immunodeficiency virus (HIV), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
    - History of malignancy within 5 years prior to screening.
    - History of alchohol or drug abuse within 1 year prior to Screening.
    - Hospitalized for psychiatric disease within 2 years prior to Screening.
    - Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
    - Bleeding disorder, known platelet dysfunction or platelet count <150 000/µL at Screening or history of significant bleeding event within 6 months prior to Screening.
    - Lymphocyte count below the lower limit of normal at Screening.
    - Recent live (attenuated) vaccine within 2 months before the first treatment visit.
    - Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
    - The participant has received medications/treatments for MS within a specified time frame.
    - Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
    - Receiving anticoagulant or antiplatelet therapy (such as aspirin, clopidogrel, warfarin).
    - Contraindications to magnetic resonance imaging (MRI).
    NOTE: Other Inclusion/Exclusion criteria may apply
    - I/Le partecipanti presentano condizioni che potrebbero influire negativamente sulla partecipazione allo studio quale ad esempio breve aspettativa di vita
    - Anamnesi di trapianto d'organo
    - Anamnesi di infezione da virus dell’immunodeficienza umana (HIV), leucoencefalopatia multifocale progressiva (PML), epatite B o C attiva, tubercolosi attiva o latente o altre infezioni attive che possano influire negativamente sulla partecipazione allo studio
    - Anamnesi di tumore maligno nei 5 anni precedenti lo screening
    - Anamnesi di abuso di alcol o di abuso di droghe nell'anno precedente lo screening
    - Ospedalizzazione per disturbo psichiatrico nei 2 anni precedenti lo screening
    - Anomalie di laboratorio clinicamente significative (ivi compresa evidenza di danno epatico) o anomalie nell'elettrocardiogramma allo screening
    - Disturbo emorragico, disfunzione piastrinica nota o conta piastrinica <150 000/µL allo screening o anamnesi di evento emorragico nei 6 mesi precedenti allo Screening
    - conta linfocitaria inferiore al limite inferiore della norma allo Screening
    - Recente vaccinazione con vaccino vivo (attenuato) nei 2 mesi precedenti la prima visita di trattamento.
    - Recente intervento chirurgico maggiore nelle 4 settimane precedenti la visita di screening o pianificazione intervento chirurgico maggiore pianificato durante lo studio
    - Il/la partecipante ha ricevuto farmaci / trattamenti per la SM entro un periodo di tempo specificato
    - Il/la partecipante sta ricevendo forti induttori o inibitori degli enzimi epatici del citocromo P450 3A (CYP3A) o di CYP2C8
    - Il/la partecipante sta ricevendo terapia anticoagulante o antipiastrinica (come aspirina, clopidogrel, warfarin)
    - Controindicazioni alla risonanza magnetica per immagini (RMI)
    NOTA: altri criteri di inclusione / esclusione possono essere applicabili
    E.5 End points
    E.5.1Primary end point(s)
    6 month Confirmed Disability Progression (CDP) ; Time to onset of 6 month CDP defined as follows:
    Increase of >/=1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is</ =5.5, or Increase of >/=0.5 points when the baseline EDSS score is >5.5
    Progressione della disabilità confermata (CDP) a 6 mesi: Tempo all’insorgenza del CDP a 6 mesi definito come segue:
    - Aumento di >/= 1,0 punti dal punteggio EDSS basale quando il punteggio basale è </= 5,5, OPPURE Aumento di >/= 0,5 punti quando il punteggio EDSS basale è > 5,5
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 48 months.
    Fino a circa 48 mesi.
    E.5.2Secondary end point(s)
    1- 3-month confirmed disability progression (CDP) ; Time to onset of 3-month CDP as assessed by EDSS score
    2- 3-month change in 9-hole peg test (9-HPT) ; Time to onset of sustained 20% increase in the 9-HPT test confirmed over at least 3 months
    3- 3-month change in timed 25 foot walk (T25-FW) ; Time to onset of sustained 20% increase in the T25-FW confirmed over at least 3 months
    4- Change in T2 hyperintense lesions by MRI ; Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)
    5- Time to onset of confirmed disability improvement (CDI) ; Time to onset of CDI defined as >/= 1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months
    6- Percent change in Brain volume loss (BVL) ; Percent change in brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6
    7- Change in cognitive function ; Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT)
    8- Change in cognitive function ; Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available
    9- Change in Multiple Sclerosis Quality of Life ; Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline
    10- Safety and Tolerability ; Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
    11- Population pharmacokinetics ; Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12
    12- Change in plasma neurofilament light chain (NfL) ; Change in NfL levels from at the EOS compared to baseline
    13- Change in lymphocyte phenotype subsets ; Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline
    14- Changes in serum Immunoglobulin level ; Changes in serum Immunoglobulin level at the EOS compared to baseline
    15- Change in serum chitinase-3 like protein 1 (Chi3L1) ; Change in serum chitinase-3 like protein 1 (Chi3L1) at EOS compared to baseline.
    1-Progressione di disabilità confermata a 3 mesi: Tempo all’insorgenza di CDP a 3 mesi, valutata mediante punteggio EDSS
    2- Variazione nel test dei 9 pioli a 3 mesi: Tempo all’insorgenza di un aumento sostenuto del 20% nel test dei 9 pioli (9-HPT) confermato per almeno 3 mesi
    3- Variazione nel test cronometrato dei 25 passi (T25 -FW) a 3 mesi : Tempo all’insorgenza di un aumento sostenuto del 20% nel test cronometrato dei 25 passi (T25-FW) confermato per almeno 3 mesi
    4- Variazione nelle lesioni iperintense in T2 rilevate da RM: numero totale di lesioni iperintense in T2 nuove e/o in espansione, rilevate mediante RM, a partire dal basale fino alla visita di fine studio (EOS) compresa
    5- Tempo all’insorgenza di CDI: Tempo all’insorgenza di CDI, definito come riduzione >/= 1,0 punti sul punteggio EDSS rispetto al basale confermato per almeno 6 mesi
    6- Variazione percentuale nella perdita di volume cerebrale (Brain Volume Loss [BVL]): Variazione percentuale nella perdita di volume cerebrale rilevata mediante scansioni RMI cerebrali alla visita EOS rispetto al Mese 6
    7- Variazione della funzione cognitiva: variazione della funzione cognitiva alla visita EOS rispetto al basale, valutata mediante test di associazione di simboli e numeri (Symbol Digit Modalities Test, [SDMT])
    8- Variazione della funzione cognitiva; variazione della funziona cognitiva alla visita EOS rispetto al basale, valutata mediante la seconda versione del Test di apprendimento verbale dell’Università della California (California Verbal Learning Test-II, [CVLT-II]), ove disponibile
    9- Variazione nel questionario di Qualità della Vita della Sclerosi Multipla; variazione nel punteggio del questionario a 54 item per la misurazione della qualità della vita associata alla sclerosi multipla (Multiple Sclerosis Quality of Life-54 [MSQoL-54]) alla EOS rispetto al basale
    10- Sicurezza e tollerabilità: numero di partecipanti con Eventi Avversi (EA), Eventi Avversi seri, Eventi Avversi che portano a interruzione permanente del trattamento dello studio, EA di speciale interesse
    11- Farmacocinetica di popolazione; Concentrazione plasmatica di SAR442168 (valutazione della PK di popolazione) ai Mesi 6, 9 e 12
    12- Variazione dei livelli plasmatici della catena leggera dei neurofilamenti (NfL): Variazione dei livelli plasmatici di NfL alla visita EOS rispetto al basale
    13-Variazione dei sottotipi di fenotipi linfocitari; Variazione dei sottotipi di fenotipi linfocitari nel sangue intero alla visita EOS rispetto al basale
    14- Variazioni del livello di immunoglobulina sierica; variazioni del livello di immunoglobulina sierica alla visita EOS rispetto al basale
    15- Variazioni dei livelli sierici di proteina chitinasi-3-simile 1 (Chitinase-3 Like Protein-1, [Chi3L1]): Variazioni dei livelli sierici di proteina chitinasi-3-simile 1 (Chi3L1) alla visita EOS rispetto al basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3 : Up to approximately 48 months
    4 : From baseline to approximately 48 months
    5 : From Baseline up to 48 approximately months
    6 : From 6 months up to approximately 48 months
    7, 8, 9, 12, 13, 14, 15 : From Baseline up to approximately 48 months
    10 : From screening up to approximately 48 months.
    11 : Months 6, 9 and 12
    1, 2, 3 : Fino a circa 48 mesi
    4 : Dal basale a circa 48 mesi
    5 : Dal basale fino a 48 mesi circa
    6 : Dal mese 6 fino a circa 48 mesi
    7, 8, 9, 12, 13, 14, 15 : Dal basale fino a circa 48 mesi
    10 : Dallo screening fino a circa 48 mesi
    11 : Mesi 6, 9 e 12

    11: mesi 6,9 e 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Belarus
    Canada
    Chile
    China
    Colombia
    India
    Israel
    Japan
    Mexico
    Peru
    Russian Federation
    Serbia
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Latvia
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 1320
    F.1.3Elderly (>=65 years) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 599
    F.4.2.2In the whole clinical trial 1320
    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)
    Participants completing the treatment period will be proposed to enroll in a separate long term safety study
    Ai pazienti che completano il periodo di trattamento verrà proposta la partecipazione ad uno studio separato sulla sicurezza a lungo termine
    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 Decision2020-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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