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    Summary
    EudraCT Number:2016-000657-12
    Sponsor's Protocol Code Number:ACT14820
    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:2017-02-08
    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 number2016-000657-12
    A.3Full title of the trial
    Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo per valutare efficacia, sicurezza, farmacocinetica e farmacodinamica di GZ/SAR402671 in pazienti con malattia di Parkinson in stadio precoce e portatori di mutazione GBA o altre varianti pre-specificate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation
    Studio globale per valutare la dinamica, l'efficacia e la sicurezza di GZ/SAR402671 in pazienti con malattia di Parkinson portatori di mutazione di gene GBA (Glucocerebrosidasi).
    A.3.2Name or abbreviated title of the trial where available
    MOVES-PD
    MOVES-PD
    A.4.1Sponsor's protocol code numberACT14820
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-6918
    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.p.A
    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 number0039800226343
    B.5.5Fax number0390239394168
    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.3.2Product code SAR402671, GZ402671 or GZ/SAR402671
    D.3.4Pharmaceutical form Capsule
    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 INN000000
    D.3.9.1CAS number 1401090-53-6
    D.3.9.2Current sponsor codeGZ/SAR402671
    D.3.9.3Other descriptive nameGenz-682452-AU
    D.3.9.4EV Substance CodeSUB166602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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.3.2Product code SAR402671, GZ402671 or GZ/SAR402671
    D.3.4Pharmaceutical form Capsule
    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 INN00000
    D.3.9.1CAS number 1401090-53-6
    D.3.9.2Current sponsor codeGZ/SAR402671
    D.3.9.3Other descriptive nameGenz-682452-AU
    D.3.9.4EV Substance CodeSUB166602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboCapsule
    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
    Parkinson's disease (PD) carrying a GBA mutation
    Malattia di Parkinson portatrice di mutazione GBA
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Malattia di Parkinson
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    -Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA mutation or other pre-specified variants.
    -Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or other prespecified variants.
    Parte 1: Determinare la sicurezza e la tollerabilità di GZ/SAR402671, rispetto al placebo, quando somministrato per via orale in pazienti affetti/e da morbo di Parkinson in fase precoce, portatori/portatrici di una mutazione nel gene della glucocerebrosidasi (GBA) o altre varianti di sequenza prespecificate.
    Parte2: Determinare l’efficacia di GZ/SAR402671, rispetto al placebo,quando somministrato giornalmente per via orale, in pazienti affetti/e da PD in fase precoce, portatori/portartici di una mutazione in GBA, o altre varianti di sequenza prespecificate
    E.2.2Secondary objectives of the trial
    Part 1:
    -To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma when administered in early-stage Parkinson's disease patients carrying a GBA mutation.
    -To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in earlystage Parkinson's disease patients carrying a GBA mutation.
    Part 2:
    -To demonstrate overall safety and tolerability of GZ/SAR4027671 administered orally in early-stage Parkinson's disease patients carrying a GBA mutation as compared to placebo.
    -To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage Parkinson's disease patients carrying a GBA mutation.
    Valutare il profilo farmacocinetico (PK) della som.ne orale giornaliera di GZ/SAR402671 nel plasma quando somministrato a pazienti affetti/e da PD in fase precoce, portatori/portatrici di una mutazione in GBA.
    •Valutare l’esposizione di GZ/SAR402671 nel liquido cerebrospinale (LCS) quando somministrato a pazienti affetti/e da PD in fase precoce, portatori/portatrici di una mutazione in GBA
    Parte2: •Dimostrare la sicurezza e la tollerabilità complessive di GZ/SAR402671, rispetto al placebo, somministrato per via orale a pazienti affetti/e da PD in fase precoce, portatori/portatrici di una mutazione in GBA.
    •Valutare la risposta farmacodinamica alla som.ne orale giornaliera di GZ/SAR402671, misurata mediante GL-1 nel plasma e nell’LCS, in pazienti affetti/e da PD in fase precoce, portatori/portatrici di una mutazione in GBA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female adults with a diagnosis of PD and who are heterozygous carriers of a GBA mutation associated with PD.
    -Patients carrying known sequence variants associated with GBA-PD (such as E326K) must have rapid eye movement (REM) sleep behavior disorder (RBD) confirmed by historically documented polysomnography or by questionnaire.
    -Age ≥18 years to 70 years inclusive at the time of informed consent signing.
    -Has symptoms of PD ≥2 years.
    -Hoehn and Yahr (H and Y) stage of 2 or lower at baseline.
    -Stable medication regimen of PD drugs for at least 30 days (at least 60 days for rasagiline) prior to randomization.
    -The patient is willing to abstain from grapefruit containing products for 72 hours prior to administration of the first dose of GZ/SAR402671 and for duration of the entire treatment period (Periods 2 and 3).
    -Signed written consent.
    -Soggetti di ambo i sessi con una diagnosi di PD e portatori eterozigoti di una mutazione in GBA.
    -I/Le pazienti portatori/portatrici di varianti di sequenza note associate a GBA-PD (come E326K) devono essere affetti/e da disturbo comportamentale del sonno con movimento rapido degli occhi (rapid-eye movement [REM] sleep behaviour disorder, RBD) confermato mediante polisonnografia documentata in anamnesi o attraverso il questionario dell’RBD.
    -Età ≥18 anni fino a 70, compresi, al momento della firma del consenso informato.
    -Presenza di sintomi di PD da ≥2 anni.
    -Stadio di PD ≤2 secondo la scala Hoehn e Yahr (H&Y) al basale.
    -Il regime terapeutico deve essere stabile per almeno 30 giorni (almeno 60 giorni per rasagilina) prima della randomizzazione.
    -Il/La paziente deve essere disposto/a ad astenersi dal consumo prodotti contenenti pompelmo per 72 ore prima della somministrazione della prima dose di GZ/SAR402671 e per la durata dell’intero periodo di trattamento (Parte 1 e Parte 2, Periodi 2 e 3).
    -Consenso informato firmato per iscritto.
    E.4Principal exclusion criteria
    -Parkinsonism due to drug(s) or toxin(s).
    -Patients carrying mutations in genes other than GBA that have been associated with an increased risk for PD, specifically LRKK2 (G2019S).
    -Patients with Gaucher disease (GD), defined by the presence of 2 mutated GBA alleles.
    -Montreal Cognitive Assessment score <20 at Screening Visit.
    -Patients with prior surgical history of deep brain stimulation (DBS).
    -Patients with baseline brain MRI without contrast showing a structural abnormality that is a possible cause of their PD signs or symptoms.
    -Hepatic insufficiency with liver function tests (LFT) >2 times upper limit of normal at Screening Visit.
    -The patient has prior known positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV 1 and anti-HIV 2 Ab). Patients with a positive hepatitis B surface antibody (HBsAb) test with a history of prior hepatitis B immunization are eligible if other criteria are met (ie, negative tests for : HBsAg, hepatitis B core antibody [HBcAb],and hepatitis C [HCVAb].
    -Renal insufficiency as defined by creatine >1.5 times normal at Screening Visit.
    -The patient has received strong or moderate inducers or inhibitors of CYP3A4 within 30 days or 5 half-lives from screening, whichever is longer, prior to randomization.
    -The patient has, according to World Health Organization (WHO) Grading, a cortical cataract > onequarter the lens circumference (grade cortical catact-2 [COR-2]) or a posterior subcapsular cataract >2 mm (grade posterior subscapsular cataract [PSC-2]). Patient with nuclear cataracts will not be excluded.
    -The patient is currently receiving potentially cataractogenic medications, including chronic regimen (more frequently than every 2 weeks) of any dose or route of corticosteroids or any medication that can cause cataract, according to the prescribing information.
    -If female, pregnancy (defined as positive beta-human chorionic gonadotrophin [Beta-HCG] blood test) or lactating or breast-feeding.
    -Any medical disorders that, in the opinion of the Investigator, could interfere with study-related procedures. This includes condition(s) that preclude the safety performance of routine lumbar punctures, such as prohibitive spinal diseases, bleeding diasthesis, or clinically significant coagulopathy or thrombocytopenia.
    -Current participation in another investigational interventional study.
    -Parkinsonismo dovuto a farmaco(i) e/o tossina(e).
    -I pazienti portatori di mutazioni in geni diversi da GBA che sono state associate con un aumentato rischio di PD, in particolare LRRK2 (G2019S)
    -Pazienti con malattia di Gaucher, definita dalla presenza di due alleli GBA mutati.
    -Punteggio MoCA <20 alla visita di screening
    -Pazienti con pregressa anamnesi chirurgica di stimolazione cerebrale profonda.
    -Pazienti la cui RM senza contrasto al basale mostra un’anomalia strutturale che rappresenta una possibile eziologia dei segni e dei sintomi correlati al PD.
    -Insufficienza epatica con test di funzionalità epatica (LFT) due volte superiore alla norma alla visita di screening.
    - I pazienti presentano risultati positivi su uno dei seguenti test: antigeni di superficie dell'epatite B (HBsAg), anticorpi anti-epatite C (anti-HCV), anticorpi per i virus dell'immunodeficienza umana 1 e 2 (anti-HIV 1 e anti-HIV 2 Ab). I pazienti con anticorpi di superficie positivi all'epatite B (HBsAb) come prova di una precedente immunizzazione possono essere inclusi se gli altri criteri sono soddisfatti (ad esempio, test negativi per: HBsAg, epatite B anticorpo nucleo [HBcAb], e l'epatite C [HCVAb] .
    -Il/La paziente presenta una diagnosi documentata, in base alle normative locali, di una qualsiasi delle seguenti infezioni: epatite B, epatite C, virus dell’immunodeficienza umana 1 o 2.
    -Insufficienza renale definita da un livello di creatinina >1,5 volte il limite superiore della norma alla visita di screening.
    -Il/La paziente ha ricevuto induttori o inibitori, forti o moderati, di CYP3A4 nei 30 giorni o nelle 5 emivite di screening precedenti la randomizzazione, a seconda di quale periodo duri di più.
    -Secondo la classificazione dell’Organizzazione mondiale della sanità (OMS), il/la paziente presenta una cataratta corticale >un quarto della circonferenza del cristallino (Grado 2 della cataratta corticale) o una cataratta sottocapsulare posteriore >2 mm (Grado 2 della cataratta sottocapsulare posteriore). I/Le pazienti con cataratte nucleari non saranno esclusi/e.
    -Il/La paziente è in trattamento con farmaci potenzialmente catarattogenici, compreso un regime cronico (con frequenza superiore a ogni 2 settimane) a qualsiasi dose o mediante qualsiasi via di somministrazione di corticosteroidi o di qualsiasi farmaco che possa provocare cataratte, in base alle Informazioni sulla prescrizione
    --Donne in stato di gravidanza (definita come positività alle analisi del sangue per la gonadotropina corionica umana beta [β-human chorionic gonadotropin, β-HCG]), in fase di allattamento o che allattano al seno.
    -Qualsiasi disturbo medico che, a giudizio dello sperimentatore, potrebbero interferire con le procedure correlate allo studio. Tra queste sono comprese una o più condizioni che precludono un’effettuazione sicura della regolare puntura lombare, tra cui patologia della colonna vertebrale lombare proibitiva, diatesi emorragica oppure coagulopatia o trombocitopenia clinicamente significativa.
    -Partecipazione concomitante a un altro studio interventistico sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part II and III score
    Variazione del punteggio relativa alla PARTE II+III della Scala di valutazione unificata del morbo di Parkinson della Società dei disturbi del movimento (MDS-UPDRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52
    Dal basale alla settimana 52
    E.5.2Secondary end point(s)
    - Change from baseline in Parkinson's Disease Cognitive Rating Scale
    - Change from baseline in Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part I, II, and III score
    - Change from baseline in Hoehn and Yahr score
    Variazione della Scala di valutazione cognitiva del morbo di Parkinson (Parkinson’s Disease Cognitive Rating Scale, PD-CRS; punteggio totale) dal basale alla Settimana 52. Variazione del punteggio della PARTE I+II+III dell’MDS-UPDRS, eseguita durante lo stato OFF, dal basale alla Settimana 52. Variazione del punteggio H&Y dal basale alla Settimana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52
    Dal basale alla settimana 52
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 No
    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
    Austria
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Norway
    Portugal
    Singapore
    Spain
    Sweden
    Taiwan
    United Kingdom
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 218
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 276
    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)
    At the end of a 52-week main placebo-controlled treatment period, all patients will be evaluated for possibility to transition to receive active treatment for 104 weeks plus 6 week post-treatment observation.
    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 Decision2016-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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