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    Summary
    EudraCT Number:2020-004400-34
    Sponsor's Protocol Code Number:LTS15823
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-08
    Trial results View 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 number2020-004400-34
    A.3Full title of the trial
    Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD)
    Studio di estensione in aperto, multicentrico, per caratterizzare l’efficacia e la sicurezza a lungo termine del trattamento precoce rispetto a quello ritardato con venglustat (GZ/SAR402671) in pazienti a rischio di rapida progressione della malattia policistica renale autosomica dominante (ADPKD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat
    Trattamento a lungo termine della malattia policistica renale autosomica dominante (ADPKD) con venglustat
    A.3.2Name or abbreviated title of the trial where available
    STAGED-PKD-EXT
    STAGED-PKD-EXT
    A.4.1Sponsor's protocol code numberLTS15823
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    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 L. 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2122
    D.3 Description of the IMP
    D.3.1Product nameVenglustat
    D.3.2Product code [SAR402671, GZ402671 o GZ/SAR402671]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNvenglustat malato
    D.3.9.1CAS number 1629063-78-0
    D.3.9.2Current sponsor codeGZ/SAR402671
    D.3.9.3Other descriptive nameGZ/SAR402671
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Congenital cystic kidney disease
    Malattia policistica renale congenita
    E.1.1.1Medical condition in easily understood language
    Congenital cystic kidney disease
    Malattia policistica renale congenita
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010428
    E.1.2Term Congenital cystic kidney disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive ADPKD.
    Determinare l’effetto del trattamento precoce rispetto a quello ritardato con venglustat sul volume renale totale (total kidney volume, TKV) in partecipanti a rischio di ADPKD in rapida progressione
    E.2.2Secondary objectives of the trial
    - To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate [eGFR]).
    - To characterize the safety profile of venglustat.
    - To evaluate the effect of venglustat on the lens by ophthalmological examination.
    - To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).
    - Determinare l’effetto del trattamento precoce rispetto a quello ritardato con venglustat sulla funzionalità renale (velocità di filtrazione glomerulare stimata [estimated glomerular filtration rate, eGFR]).
    - Caratterizzare il profilo di sicurezza di venglustat
    - Valutare l’effetto di venglustat sul cristallino mediante un esame oftalmologico
    - Valutare l’effetto di venglustat sull’umore, utilizzando la classificazione della depressione di Beck-II (Beck Depression Inventory-II, BDI-II).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female adult with ADPKD who has completed the treatment period in Stage 1 or Stage 2 of Study EFC15392.
    - The patient has an eGFR >30 mL/min/1.73 m2:
    a) measured at Visit 11 of the EFC15392 study for participant enrolled in the LTS15823 study at the time of Visit 12 (Month 24; end-of treatment visit) of the EFC15392 study.
    b) measured at Screening visit for participant enrolled in the LTS15823 study not concomitantly to the Visit 12 (Month 24; end-of treatment visit) of the EFC15392 study.
    - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    a) Male participants must agree to practice true abstinence in line with their preferred and usual lifestyle or to use double-contraceptive methods for the entire duration of the study and for at least 90 days following their last dose of IMP.
    b) Female participants must have a negative urine pregnancy test at the Baseline visit and agree to practice true abstinence in line with their preferred and usual lifestyle or to use double contraceptive methods (including a highly effective method of contraception) for the entire duration of the study and for at least 6 weeks following their last dose of IMP.
    - Capable of giving signed informed consent before performance of any study related procedures not part of standard medical care.
    - Able to read, comprehend, and respond to the study questionnaires.
    - Adulto di sesso maschile o femminile con ADPKD che ha completato il periodo di trattamento nella Fase 1 o nella Fase 2 dello studio EFC15392.
    - Il/La paziente presenta un eGFR >30 ml/min/1,73 m2:
    a) misurato alla Visita 11 dello studio EFC15392 per il/la partecipante arruolato/a nello studio LTS15823 al momento della Visita 12 (Mese 24; visita di fine trattamento) dello studio EFC15392.
    b) misurato alla visita di screening per il/la partecipante arruolato/a nello studio LTS15823 non in concomitanza alla Visita 12 (Mese 24; visita di fine trattamento) dello studio EFC15392
    - L'uso di contraccettivi da parte di uomini e donne deve essere in linea con le normative locali riguardanti i metodi di contraccezione per coloro che partecipano agli studi clinici.
    a) I partecipanti di sesso maschile devono accettare di praticare una effettiva astinenza in linea con lo stile di vita preferito e abituale o di utilizzare metodi contraccettivi doppi per l’intera durata dello studio e per almeno 90 giorni dopo l’ultima dose dell’IMP.
    b) Le partecipanti di sesso femminile devono presentare un test di gravidanza sulle urine negativo alla visita basale e accettare di praticare una effettiva astinenza se in linea con il proprio stile di vita preferito e abituale oppure di utilizzare metodi contraccettivi doppi (compreso un metodo contraccettivo altamente efficace) per l’intera durata dello studio e per almeno 6 settimane dopo l’ultima dose dell’IMP.
    - In grado di fornire un consenso informato firmato prima dell’effettuazione di eventuali procedure correlate allo studio non incluse nelle cure mediche standard.
    - In grado di leggere, comprendere e rispondere ai questionari dello studio.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    For participants who have lag phase between the end of the EFC15392 study and Screening visit (Visit 0) in the LTS15823 study:
    -The patient has a new clinically significant, uncontrolled medical condition that, in the opinion of the Investigator, would put the safety of the patient at risk through participation, or which would affect the efficacy or safety analysis if the condition exacerbated during the study, or that may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities.
    -A history of drug abuse and/or alcohol abuse or alcohol dependence during the lag phase between the end of the EFC15392 study and Screening visit (Visit 0) in the LTS15823 study when applicable.
    -Administration of tolvaptan or other polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screening visit (Visit 0) in the LTS15823 study when applicable.
    -The patient is currently receiving potentially cataractogenic medications, including a chronic regimen (more frequently than every 2 weeks) of any route of corticosteroids (including medium and high potency topical steroids), or any medication that may cause cataract, according to the Prescribing Information.
    -The patient has received strong or moderate inducers or inhibitors of CYP3A4 within 14 days or 5 half lives, whichever is longer, prior to the Baseline visit (including consumption of grapefruit-containing products within 72 hours of starting venglustat administration).
    -Participation in another investigational interventional study or use of IMP, within 3 months or 5 half-lives, whichever is longer, before the Baseline visit (Visit 1) except participation in the EFC15392 study when applicable.
    -Liver enzymes (alanine aminotransferase /aspartate aminotransferase) or total bilirubin >2 times the upper limit of normal unless the patient has the diagnosis of Gilbert syndrome. Patients with the Gilbert syndrome should have no additional symptoms or signs which suggest hepatobiliary disease and serum total bilirubin level no more than 3 mg/dL (51 µmol/L) with conjugated bilirubin less than 20% of the total bilirubin fraction.

    For participants with or without lag phase between the end of EFC15392 study and entry into LTS15823 study:
    -The patient is pregnant or lactating.
    -Presence of severe depression as measured by Beck Depression Inventory II >28 at Visit 1 (for participants enrolled in the LTS15823 study at the time of the end of treatment visit of the EFC15392 study) or at Visit 0 (for participants enrolled in the LTS15823 study after the end-of-treatment visit of the EFC15392 study).
    -Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
    In presenza di uno dei seguenti criteri i partecipanti saranno esclusi dallo studio:
    Per i/le partecipanti che presentano una fase di ritardo tra la fine dello studio EFC15392 e la visita di screening (Visita 0) nello studio LTS15823:
    - Il/La paziente presenta una condizione medica clinicamente significativa e non controllata che, secondo il parere dello Sperimentatore, metterebbe a rischio la sicurezza del/la paziente con la partecipazione, o che influirebbe sull’analisi di efficacia o sicurezza se la condizione si aggravasse durante lo studio o che potrebbe interferire significativamente con l’aderenza allo studio, comprese tutte le valutazioni e le attività di follow-up prescritte.
    - Anamnesi di abuso di droghe e/o abuso di alcol o dipendenza da alcol durante la fase di ritardo tra la fine dello studio EFC15392 e la visita di screening (Visita 0) nello studio LTS15823, ove applicabile.
    - Somministrazione di tolvaptan o altri agenti modificanti la malattia policistica renale (analoghi della somatostatina) nei 3 mesi precedenti la visita di screening (Visita 0) nello studio LTS15823, ove applicabile.
    - Il paziente sta attualmente ricevendo farmaci potenzialmente catarattogenici, compreso un regime cronico (con frequenza superiore a ogni 2 settimane) mediante qualsiasi via di somministrazione di corticosteroidi (inclusi gli steroidi topici a medio ed elevato potenziale) o di qualsiasi farmaco che possa provocare cataratte, in base alle Informazioni sulla prescrizione.
    - Il/La paziente ha ricevuto induttori o inibitori, forti o moderati, di CYP3A4 nei 14 giorni o nelle 5 emivite precedenti la visita basale, a seconda di quale periodo duri di più (incluso anche il consumo di prodotti contenenti pompelmo entro 72 ore dall’inizio della somministrazione di venglustat.
    - Partecipazione a un altro studio interventistico sperimentale o uso dell’IMP, entro 3 mesi o 5 emivite, a seconda di quale periodo duri di più, prima della visita basale (Visita 1), fatta eccezione per la partecipazione allo studio EFC15392, ove applicabile.
    - Enzimi epatici (alanina aminotransferasi/aspartato aminotransferasi) o bilirubina totale >2 volte il limite superiore della norma (ULN) a meno che il/la paziente non presenti una diagnosi di sindrome di Gilbert. I/Le pazienti con la sindrome di Gilbert non devono presentare sintomi o segni aggiuntivi che suggeriscano malattia epatobiliare e il livello di bilirubina totale sierica non sia superiore a 3 mg/dl (51 µmol/l) con bilirubina coniugata inferiore al 20% della frazione di bilirubina totale.

    Per i/le partecipanti con o senza fase di ritardo tra la fine dello studio EFC15392 e l’ingresso nello studio LTS15823:
    - La paziente è in gravidanza o in allattamento.
    - Presenza di depressione grave misurata mediante classificazione della depressione di Beck II (BDI-II) >28 alla Visita 1 (per i/le partecipanti arruolati/e nello studio LTS15823 al momento della visita di fine trattamento dello studio EFC15392) o alla Visita 0 (per i/le partecipanti arruolati/e nello studio LTS15823 dopo la visita di fine trattamento dello studio EFC15392).
    - Sensibilità a uno qualsiasi dei trattamenti dello studio o a componenti dello stesso, o al farmaco o altre allergie che, secondo il parere dello sperimentatore, rappresentino una controindicazione alla partecipazione al presente studio
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in TKV: Percent change in TKV based on magnetic resonance imaging (MRI) from the EFC15392 study baseline to 24 months of open-label extension study, in early treated and delayed-treated participants
    Variazione percentuale del TKV: Variazione percentuale del TKV in base alla risonanza magnetica per immagini (RM) dal basale dello studio EFC15392 a 24 mesi di studio di estensione in aperto, in partecipanti trattati/e precocemente e in ritardo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the EFC15392 study baseline to 24 months of open-label extension study
    Dal basale dello studio EFC15392 a 24 mesi di studio di estensione in aperto
    E.5.2Secondary end point(s)
    1 - Change in eGFR: Change in eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) from the EFC15392 study baseline to 24 months of open label extension study, in early treated and delayed-treated participants
    2 - Number of adverse events
    3 - Change in lens clarity: Change from EFC15392 study baseline in the lens clarity by ophthalmological examination during the open label extension treatment-emergent period
    4 - Change in score of Beck Depression Inventory- II (BDI-II): Change from EFC15392 study baseline in BDI II score during the open-label extension treatment emergent period
    1- Variazione nell’eGFR: Variazione nell’eGFR (equazione della Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) dal basale dello studio EFC15392 a 24 mesi di studio di estensione in aperto, in partecipanti trattati/e precocemente e in ritardo
    2- Numero di eventi avversi.
    3- Variazione della trasparenza del cristallino: Variazione rispetto al basale dello studio EFC15392 della trasparenza del cristallino mediante esame oftalmologico durante il periodo di estensione in aperto emergente dal trattamento.
    4- Variazione nel punteggio BDI-II: Variazione rispetto al basale dello studio EFC15392 nel punteggio BDI-II durante il periodo di estensione in aperto emergente dal trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: From the EFC15392 study baseline to 24 months of open-label extension study
    2: From 1st treatment intake to last treatment of open-label extension study + 30 days
    3,4: From EFC15392 study baseline to last treatment of open-label extension study + 30 days
    1: dal basale dello studio EFC15392 a 24 mesi di studio di estensione in aperto
    2: dalla prima somministrazione del trattamento all'ultimo trattamento dello studio di estensione in aperto + 30 giorni
    3, 4: dal basale dello studio EFC15392 all'ultimo trattamneto dello studio di estensione in aperto + 30 giorni
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Canada
    China
    Israel
    Korea, Republic of
    Taiwan
    Turkey
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    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 months8
    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 months4
    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: 640
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 640
    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)
    .
    .
    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 Decision2021-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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