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    Summary
    EudraCT Number:2018-001508-12
    Sponsor's Protocol Code Number:CVAY736X2208
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-13
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-001508-12
    A.3Full title of the trial
    A placebo-controlled, patient and investigator blinded, randomized parallel
    cohort study to assess pharmacodynamics, pharmacokinetics, safety,
    tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in
    patients with systemic lupus erythematosus (SLE)
    Étude randomisée, en double aveugle contre placebo, en groupes parallèles visant à évaluer la pharmacodynamie, la pharmacocinétique, la sécurité, la tolérabilité et l'efficacité clinique préliminaire de VAY736 et CFZ533 chez des patients atteints de lupus érythémateux disséminé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)
    Etude sur l'efficacité et la sécurité de VAY736 et CFZ533 chez des patients atteints de lupus érythémateux disséminé
    A.4.1Sponsor's protocol code numberCVAY736X2208
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S.
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address2 et 4 rue Lionel Terray
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155476600
    B.5.5Fax number+33155476100
    B.5.6E-mailicm.phfr@novartis.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 VAY736
    D.3.4Pharmaceutical form Powder for 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 INNianalumab
    D.3.9.2Current sponsor codeVAY736
    D.3.9.3Other descriptive nameVAY736
    D.3.9.4EV Substance CodeSUB31641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 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.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 CFZ533
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNiscalimab
    D.3.9.2Current sponsor codeCFZ533
    D.3.9.3Other descriptive nameCFZ533
    D.3.9.4EV Substance CodeSUB130512
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 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 placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus (SLE)
    Lupus systémique
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus (SLE)
    Lupus systémique
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the effect of VAY736 and of CFZ533 versus their respective placebo on disease activity in SLE patients using the SRI-4 index.
    Evaluer l’effet de VAY736 et CFZ533 vs. leurs placebos respectifs sur l’activité de la maladie chez des patients atteints de LS en utilisant l’index SRI-4.
    E.2.2Secondary objectives of the trial
    - To assess safety and tolerability in patients with SLE by recording all adverse events
    - To determine the change from baseline in the Physicians’ Global Assessment (PhGA) at Week 29 by using a visual analogue scale (VAS)
    - To determine the change from baseline in the Patient's Global Assessment (PGA) at Week 29 by using a patients VAS
    - To determine the pharmacokinetics (PK) of multiple doses of VAY736
    (s.c.) and CFZ533 (i.v.) in SLE patients by analyzing PK concentrations in blood
    - To assess the effect of VAY736 and of CFZ533 versus their respective
    placebo to prevent disease flares in SLE patient’s using BILAG-2004
    - To evaluate the immunogenicity of multiple doses of VAY736 (s.c.) or
    CFZ533 (i.v.) in SLE patients by analyzing anti-drug antibodies in blood
    - To evaluate the pharmacodynamics (PD; rate, extent and duration of
    target engagement) of multiple doses of CFZ533 in SLE patients by analyzing total soluble CD40 in plasma
    - Evaluer la sécurité d’emploi et la tolérance de VAY736 et CFZ533 en enregistrant les évènements indésirables
    - Déterminer la variation à la Semaine 29 par rapport à la baseline de l’évaluation globale du médecin (PhGA) grâce à l’échelle visuelle analogique (EVA)
    - Déterminer la variation à la Semaine 29 par rapport à la baseline de l’évaluation globale du patient(PhGA) grâce à l’échelle visuelle analogique (EVA)
    - Déterminer la pharmacocinétique (PK) de doses multiples de VAY736 (s.c.) et CFZ533 (i.v.) grâce à la concentration sérique
    - Evaluer l’effet de VAY736 et CFZ533 vs. leurs placebos respectifs dans la prévention des exacerbations grâce à l'échelle BILAG-2004
    - Evaluer l’immunogénicité de doses multiples de VAY736 (s.c.) ou de CFZ533 (i.v.) grâce à l'analyse des anticorps anti-médicament
    - Evaluer la pharmacodynamie (PD ; taux, étendue et durée de fixation à la cible) de multiples doses de CFZ533 par l'analyse de CD40 soluble dans le plasma

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent must be obtained before any assessment is performed
    - Male and female patients 18 to 75 years of age
    - Fulfill ≥4 of the 11 American College of Rheumatology 1997 classification criteria for SLE
    - Patient diagnosed with SLE for at least 6 months prior to screening
    - Elevated serum titers at screening of ANA (≥1:80) of a pattern consistent with an SLE diagnosis, including either anti-double stranded DNA (anti-ds DNA), anti-Ro (SSA), anti-La (SSB), anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm)
    - Currently receiving corticosteroids and/or antimalarials and/or another DMARD on a stable dose according to protocol requirements
    - SLEDAI-2K score of ≥6 at screening
    - BILAG 2004 score of ≥1A or ≥2B in mucocutaneous domain at screening
    - Weigh at least 40 kg at screening
    - Other protocol-defined inclusion criteria may apply
    - Un consentement éclairé écrit doit être recueilli avant toute procédure
    - Hommes et femmes âgés de 18 à 75 ans
    - Présence d’au moins 4 des 11 critères de LS selon la classification de l’American College of Rheumatology 1997
    - Diagnostic de LS depuis au moins 6 mois au moment de la sélection
    - Titres sériques d’anticorps antinucléaires (ANA) élevés (≥1/80) avec un profil compatible àun diagnostic de LS, incluant soit des anticorps anti ADN double brin, anti-Ro (SSA), anti-La (SSB), anti-ribonucléoprotéines (anti-RNP) ou anti-Smith (anti-Sm) à la sélection
    - Traitement en cours par corticostéroïdes et/ou antipaludéens et/ou un médicament antirhumatismal modificateur de la maladie (DMARD) selon les modalités du protocole
    - Score SLEDAI-2K ≥ 6 (Gladman et al 2002) à la sélection
    - Score BILAG 2004 ≥1A ou ≥2B dans le domaine mucocutané (Isenberg et al 2005; Isenberg et al 2011; Yee et al 2006; Yee et al 2010) à la sélection
    - Poids ≥ 40 kg à la sélection

    D'autres critères définis dans le protocole peuvent s'appliquer
    E.4Principal exclusion criteria
    Cohort 2 (CFZ533/Placebo) only:
    - Patients who are at significant risk for thromboembolic events based on the following:
    -- History of either thrombosis or 3 or more spontaneous abortions
    -- Presence of lupus anticoagulant or significantly prolonged partial thromboplastin time (PTT) consistent with co-existent anti-phospholipid syndrome and without concurrent prophylactic treatment with aspirin or anticoagulants as per local standard of care

    All Cohorts:
    - History of receiving prior to screening:
    -- Within 12 weeks: i.v. corticosteroids, calcineurin inhibitors or mycophenolate mofetil
    -- Within 24 weeks: cyclophosphamide, intravenous Ig, plasmapheresis, anti-TNF-a mAb, CTLA4-Fc Ig (abatacept) or BAFF targeting agents (e.g., belimumab)
    -- Any B-cell depleting therapies (administered >1 year ago) and with a Bcell count <50 cells/μL at time of screening; or, any B-cell depleting therapies within 52 weeks prior to screening
    - Evidence of active tuberculosis as assessed by Quantiferon testing at screening
    - Presence of human immunodeficiency virus (HIV) infection at screening
    - Severe organ dysfunction or life threatening disease; ECOG performance status > 1 at screening
    - History of WHO Class III-IV renal involvement with proliferative disease or nephrotic range proteinuria (above 2 g/day) requiring immune suppressive induction or maintenance treatment exceeding
    protocol-defined limits
    - Active viral, bacterial or other infections at the time of screening or enrollment
    - Receipt of live/attenuated vaccine within a 2month period before first dosing
    - Uncontrolled, co-existing serious disease, e.g., uncontrolled hypertension, heart failure, type I diabetes, thyroid disease within 3 months prior to first dosing, or significant, unresolved illness within 2
    weeks prior to first dosing
    - History of hypersensitivity to drugs of similar chemical class

    - Other protocol-defined exclusion criteria may apply
    Cohorte 2 (CFZ533/Placebo) uniquement :
    - Patients à risque significatif d’événements thromboemboliques :
    Antécédent de thrombose ou d’au moins trois avortements spontanés
    Présence d’un anticoagulant lupique ou allongement significatif du temps de céphaline activée compatible avec un syndrome anti-phospholipide et sans traitement prophylactique concomitant par aspirine ou anticoagulant selon les traitements standards locaux
    Toutes cohortes
    - Traitements suivants reçus avant la sélection :
    Dans les 12 semaines : corticostéroïdes, inhibiteurs de la calcineurine ou mycophénolate mofétil
    Dans les 24 semaines : cyclophosphamide, immunoglobulines intraveineuses, plasmaphérèse, anticorps monoclonaux anti-TNF-a, CTLA4-Fc Ig (abatacept) ou agents ciblant le BAFF (par exemple, belimumab)
    Tout traitement visant la déplétion des cellules B (par exemple, anticorps monoclonal anti-CD20, anticorps monoclonal anti-CD22, anticorps monoclonal anti-CD52) ou TACI-Ig (atacicept) administré plus d’un an avant et un compte de cellules B < 50 cellules/μL au moment de la sélection ; ou tout autre traitement visant la déplétion des cellules B dans les 52 semaines avant la sélection
    - Tuberculose active mise en évidence par un test Quantiferon à la sélection.
    - Infection par le virus de l'immunodéficience humaine (VIH) à la sélection
    - Dysfonction d’organe sévère ou maladie engageant le pronostic vital ; score de performance ECOG > 1 à la sélection
    - Antécédents rénaux de classe III-IV (classification de l’OMS) avec maladie proliférative ou protéinurie d'ordre néphrotique (supérieure à 2 g/j) nécessitant un traitement immunosuppresseur d’induction ou d’entretien au-delà des limites définies dans le point 6 des critères d’inclusion
    - Infection active virale, bactérienne ou autre au moment de la sélection
    Administration d’un vaccin vivant ou atténué dans les deux mois avant la première administration du traitement de l’étude
    - Maladie concomitante grave et non contrôlée telle que : hypertension artérielle non contrôlée, insuffisance cardiaque, diabète de type I, maladie thyroïdienne au cours des 3 mois avant la première administration du traitement de l’étude ou maladie grave non résolue dans les 2 semaines avant la première administration
    Antécédents d’hypersensibilité à des médicaments de classe chimique similaire

    D'autres critères définis dans le protocole peuvent s'appliquer
    E.5 End points
    E.5.1Primary end point(s)
    SRI-4 response status at Week 29 with reduced steroid dose maintained between Weeks 17 and 29
    Réponse à l’index SRI-4, à la Semaine 29 avec une dose réduite de corticostéroïdes maintenue entre les Semaines 17 et 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    29 Weeks
    29 semaines
    E.5.2Secondary end point(s)
    - Changes between baseline and Week 29 in the PhGA visual analog scale (VAS) assessing patient’s overall disease activity
    - Changes between baseline and Week 29 in the PGA visual analog scale (VAS) assessing patient’s global disease activity
    - Flare rate and time to first flare, with flare defined as one new ‘A’ score or two or more ‘B’ score using BILAG-2004
    - Time to first flare, with flare defined as one new ‘A’ score or two or more ‘B’ score using BILAG -2004
    - PK Cohort 1 (VAY736): free VAY736 serum concentration (Cmax at steady state)
    - PK Cohort 1 (VAY736): free VAY736 serum concentration (Ctrough at steady state)
    - PK Cohort 2 (CFZ533): free CFZ533 concentration in plasma (Cmax at steady state).
    - PK Cohort 2 (CFZ533): free CFZ533 concentration in plasma (Ctrough at steady state).
    - PD Cohort 2 (CFZ533): total soluble CD40 in plasma.
    - Variations entre la baseline et la Semaine 29 du score de l’échelle visuelle analogique (EVA) PhGA évaluant l’activité globale de la maladie selon le médecin
    - Variations entre la baseline et la Semaine 29 du score de l’échelle visuelle analogique (EVA) PGA évaluant l’activité globale de la maladie selon le patient
    - Taux d’exacerbations et temps de survenue de la première exacerbation ; l’exacerbation est définie comme un nouveau score « A » ou au moins deux scores « B » selon l’échelle BILAG-2004
    - Temps de survenue de la première exacerbation ; l’exacerbation est définie comme un nouveau score « A » ou au moins deux scores « B » selon l’échelle BILAG-2004
    - PK Cohorte 1 (VAY736) : concentration sérique de VAY736 libre (Cmax à l’état d’équilibre)
    - PK Cohorte 1 (VAY736) : concentration sérique de VAY736 libre (Cmin à l’état d’équilibre)
    - PK Cohorte 2 (CFZ533) : concentration dans le plasma de CFZ533 libre (Cmax à l’état d’équilibre)
    - PK Cohorte 2 (CFZ533) : concentration dans le plasma de CFZ533 libre (Cmin à l’état d’équilibre)
    - PD Cohorte 2 (CFZ533) : CD40 soluble dans le plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    29 Weeks
    29 Weeks
    18 months
    18 months
    End of Study
    End of Study
    18 months
    18 months
    18 months
    29 semaines
    29 semaines
    18 mois
    18 mois
    Fin de l'étude
    Fin de l'étude
    18 mois
    18 mois
    18 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Tolerability
    Immunogénicité
    Tolérance
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Argentina
    Australia
    China
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Japan
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    Thailand
    E.8.7Trial has a data monitoring committee No
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 120
    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)
    Each patient will be required to complete the study in its entirety and thereafter no further study treatment will be made available to them, unless required by local regulations.
    Après la complétion de l'étude, aucun traitement ne sera disponible pour les patients, sauf si requis par la législation du pays.
    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 Decision2019-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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