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    Summary
    EudraCT Number:2015-004059-29
    Sponsor's Protocol Code Number:GNC-003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 number2015-004059-29
    A.3Full title of the trial
    An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis
    Studio internazionale, in doppio cieco, randomizzato, controllato verso placebo di fase IIb per valutare l’efficacia, la sicurezza e la farmacocinetica di GNbAC1 in pazienti affetti da sclerosi multipla recidivante remittente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis
    Studio clinico per valutare l'efficacia, la sicurezza e la farmacocinetica di GnbAC1 in pazienti affetti da sclerosi multipla recidivante remittente
    A.3.2Name or abbreviated title of the trial where available
    CHANGE-MS
    CHANGE-MS
    A.4.1Sponsor's protocol code numberGNC-003
    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 SponsorGENEURO SA
    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 supportGeNeuro SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials Ltd
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, 172 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 207 121 6161
    B.5.5Fax number+44 207 121 6160
    B.5.6E-mailsvetlana.badnjarevic@wwctrials.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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1393641-34-3
    D.3.9.2Current sponsor codeGNbAC1
    D.3.9.4EV Substance CodeSUB174388
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1393641-34-3
    D.3.9.2Current sponsor codeGNBAC1
    D.3.9.4EV Substance CodeSUB174388
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1393641-34-3
    D.3.9.2Current sponsor codeGNBAC1
    D.3.9.4EV Substance CodeSUB174388
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSolution for 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
    Multiple Sclerosis (MS)
    Sclerosi Multipla (SM)
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS)
    Sclerosi Multipla (SM)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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 assess the efficacy of repeated doses of GNbAC1 in patients with MS based on the cumulative number of gadolinium (Gd)-enhancing T1 lesions on brain MRI vs. placebo.
    L’obiettivo primario è la valutazione dell’efficacia di dosi ripetute di GNbAC1 in pazienti affetti da SM, sulla base del numero cumulativo di lesioni captanti gadolinio (Gd) in T1 alla RMI cerebrale rispetto al placebo.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of GNbAC1 on other parameters of disease activity
    - To evaluate the safety and tolerability of repeated doses of GNbAC1
    - To evaluate pharmacokinetics of repeated doses of GNbAC1
    - valutare ­l'effetto di GNbAC1 sulle altre misurazioni degli outcome clinici
    - valutare la sicurezza e la tollerabilità di dosi ripetute di GNbAC1
    - valutare la farmacocinetica (PK) di dosi ripetute di GNbAC1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of relapsing remitting multiple sclerosis according to Mc Donald criteria (2010)
    - Evidence of recent disease activity: at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
    - Body weight > 40 kg and ≤ 100 kg;
    - EDSS score < 6.0
    - Patient (male or female with reproductive potential) who agree to use a highly effective method of birth control.
    -Other criteria as stated in study protocol
    -Clinical stability for 30 days prior to selection
    - Results of physical examination and laboratory tests must be available and free of any clinical significant abnormality likely to interfere with the study conduct or evaluation.
    ­- I pazienti potenzialmente fertili di entrambi i sessi devono accettare di far uso di un metodo contraccettivo altamente efficace per l'intera durata dello studio e per 5 mesi dopo la somministrazione dell'ultima dose del trattamento in studio, allo scopo di evitare una gravidanza della paziente o della partner del paziente.
    ­- Età compresa tra 18 e 55 anni.
    ­- Peso corporeo > 40 kg e ≤ 100 kg.
    ­- SMRR secondo i criteri di McDonald aggiornati 2010.
    ­- Attività della malattia caratterizzata da almeno una recidiva documentata negli ultimi 12 mesi e/o almeno una lesione captante gadolinio in T1 al momento della selezione o evidenziata negli ultimi 3 mesi.
    ­- Punteggio EDSS < 6,0.
    ­- Pazienti che non assumono farmaci non ammessi e per i quali sono stati rispettati i periodi di washout dai farmaci non ammessi precedentemente sospesi.
    ­- Pazienti disposti e in grado di sottoporsi a tutte le indagini e valutazioni dello studio previste dal protocollo dello studio.
    ­- Accordo del consenso informato scritto alla partecipazione prima dell’esecuzione di ogni indagine dello studio, come documentato dalla sottoscrizione della dichiarazione di consenso per il soggetto.
    -­Che sia stabile dal punto di vista clinico per 30 giorni prima della selezione
    -Gli esiti dell’esame obiettivo e delle analisi di laboratorio devono essere disponibili e non devono presentare anomalie cliniche significative probabilmente in grado di interferire con la conduzione o la valutazione dello studio.
    E.4Principal exclusion criteria
    - Patients suffering from secondary progressive MS (SPMS) or primary progressive MS (PPMS);
    - Any disease other than MS that could better explain signs and symptoms;
    - Complete transverse myelitis or bilateral optic neuritis;
    - Patients who have been treated with: oral or systemic corticosteroids, adrenocorticotropic hormone (ACTH) within 30 days prior to selection ; interferon beta or glatiramer acetate, intravenous immunoglobulin (IVIG), natalizumab, dimethylfumarate, teriflunomide, laquinimod or fingolimod in the last 3 months prior to selection ; mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, cytotoxic or immunosuppressive therapy (excluding systemic steroid and ACTH), total lymphoid irradiation or bone marrow transplantation at any time ; any cytokine (other than interferon), B cell modulating therapy such as anti-CD 20 antibodies such as ocrelizumab, ofatumumab or rituximab or daclizumab (anti-CD 25 antibody), or anti-cytokine therapy, plasmapheresis or azathioprine in the last 6 months prior to selection ; ongoing treatment with an experimental drug; preceding treatment with another experimental drug if not washed out for ≥ 5 halflives or ≥ 3 months (whichever is longer);
    - CTCAE Grade 2 or greater lymphopenia following treatment with an immunosuppressor or immunomodulator;
    - Any major medical or psychiatric disorder
    - History or presence of serious or acute heart disease
    - Known inability to undergo an MRI scan
    - patients with contraindications to the use of gadolinium-containing contrast agents or glucose 5% solution for infusion
    - positive serology for hepatitis B/C , HIV
    - abnormal liver function tests (ASAT, ALAT, Total bilirubin >2ULN; AP >3 ULN)
    - Moderate to Severe Renal impairment
    - positive pregnancy test
    - Treatment-naïve patients: patients who have never been treated with a disease modifying treatment
    - other criteria as stated in the study protocol
    ­- Test sierologici positivi per epatite virale B e/o C (se non giustificai da vaccinazione o da un'infezione passata ora risolta) e/o virus dell’immunodeficienza umana (HIV) (alla selezione).
    ­- Valori anomali dei test di funzionalità epatica (aspartato aminotransferasi [AST] o alanina aminotransferasi [ALT] > 2 volte il limite superiore della norma (ULN) o bilirubina totale > 2 volte l’ULN o fosfatasi alcalina (AP) > 3 volte l’ULN).
    ­- Compromissione renale da moderata a severa (velocità di filtrazione glomerulare < 40 mL/min [basata sulla clearance della creatinina secondo l’equazione di Cockcroft Gault]). Calcoli GFR da basarsi sui risultati relativi alla creatinina derivanti dalla visita di selezione.
    ­- Test di gravidanza positivo.
    - ­ Pazienti naïve al trattamento: pazienti che non hanno mai ricevuto un trattamento modificante la malattia.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative number of Gd-enhancing T1 lesions measured using repeated MRI assessments from Week 12 to 24.
    numero cumulativo di lesioni captanti gadolinio in T11 dalla Settimana 12 alla Settimana 24.
    Ai fini delle valutazioni dell’efficacia, per “lesioni” si intendono le lesioni evidenziate alla RMI cerebrale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From week 12 to 24
    valutato a 24 settimane
    E.5.2Secondary end point(s)
    Secondary endpoints assessed at 24 weeks (end of the placebo-controlled Period 1): • Cumulative number of combined unique active (CUA) lesions computed from Week 12 to 24; • Number of Gd-enhancing T1 lesions at Week 24; • Cumulative number of new T2 lesions from Week 12 to 24; • Percentage of patients free of Gd-enhancing T1 lesions over 24 weeks and at Week 24; • Percentage of patients free of new T2 lesions over 24 weeks and at Week 24; • Percentage of patients free of new T1-hypointense lesions (e.g. black holes) over 24 weeks and at Week 24; • Change from baseline (SD1) in total volume (mm3) of T1 hypointense lesions at Week 24 (T1 burden of disease); • Change from baseline (SD1) in total volume (mm3) of T2 lesions at Week 24 (T2 burden of disease); • MS relapse (annualised relapse rate from baseline (SD1) to Week 24, percentage of patients free of relapse at Week 24, time to first relapse); • Percentage of patients with No Evidence of Disease Activity (NEDA): no relapse, no EDSS confirmed progression, no Gdenhancing T1 lesions, no new/enlarged T2 lesions; • Progression of handicap (defined by an increase of at least 1 point on the EDSS) from baseline (SD1) to week 24. Secondary endpoints assessed at 48 weeks (end of the active-only extension Period 2): • Cumulative number of Gd-enhancing T1 lesions measured from Week 24 to 48; • Cumulative number of Gd-enhancing T1 lesions measured from Week 12 to 48; • Cumulative number of T2 lesions measured from Week 24 to 48; • Cumulative number of T2 lesions measured from Week 12 to 48; • MS relapse (annualised relapse rate from Week 24 to 48, annualised relapse rate from baseline to Week 48, percentage of patients free of relapse, time to first relapse); • Percentage of patients with No Evidence of Disease Activity (NEDA): no relapse, no EDSS confirmed progression, no Gd-enhancing T1 lesions, no new/enlarged T2 lesions; • Progression of handicap (defined by an increase of at least 1 point on the EDSS) from baseline (SD1) to week 48; • Percentage of confirmed disability (EDSS change ≥ 1.5 points for patient with EDSS = 0; EDSS change ≥ +1.0 point for patients with EDSS > 0 and < 5.5; or EDSS change ≥ +0.5 point for patients with EDSS ≥ 5.5 confirmed after 3 months) from baseline (SD1) to Week 48.
    Endpoint secondari valutati a 24 settimane (ossia alla fine del Periodo 1 controllato con placebo): • numero cumulativo delle lesioni cerebrali attive uniche combinate (CUA) conteggiate dalla Settimana 12 alla Settimana 24; • numero di lesioni captanti gadolinio in T1 alla Settimana 24; • numero cumulativo di nuove lesioni in T2 dalla Settimana 12 alla Settimana 24; • percentuale di pazienti liberi da lesioni captanti gadolinio in T1 nel corso di 24 settimane e alla Settimana 24; • percentuale di pazienti liberi da nuove lesioni in T2 nel corso di 24 settimane e alla Settimana 24; • percentuale di pazienti liberi da nuove lesioni ipointense in T1 (ad es. buchi neri) nel corso di 24 settimane e alla Settimana 24; • variazione dal basale (SD1) del volume totale (mm3) delle lesioni ipointense in T1 alla Settimana 24 (carico della malattia in T1); • variazione dal basale (SD1) del volume totale (mm3) delle lesioni in T2 alla Settimana 24 (carico di malattia in T2); • recidiva della SM (tasso di recidiva annualizzato dal basale (SD1) alla Settimana 24, percentuale di pazienti liberi da recidiva alla Settimana 24, tempo alla prima recidiva); • percentuale di pazienti con nessuna evidenza di attività della malattia (NEDA): assenza di recidiva, assenza di progressione confermata dall’EDSS, assenza di lesioni captanti gadolinio in T1, assenza di lesioni nuove/più estese in T2; • progressione della disabilità (definita da un aumento di almeno 1 punto nella scala EDSS) dal basale (SD1) alla Settimana 24. Endpoint secondari valutati a 48 settimane (ossia alla fine del Periodo 2 di estensione solo con il trattamento attivo): • numero cumulativo di lesioni captanti gadolinio in T1 misurate dalla Settimana 12 alla Settimana 48; • numero cumulativo di lesioni in T2 misurate dalla Settimana 24 alla Settimana 48; • numero cumulativo di lesioni in T2 misurate dalla Settimana 12 alla Settimana 48; • recidiva della SM (tasso di recidiva annualizzato dalla Settimana 24 alla Settimana 48, tasso di recidiva annualizzato dal basale alla Settimana 48, percentuale di pazienti liberi da recidiva, tempo alla prima recidiva); • percentuale di pazienti con nessuna evidenza di attività della malattia (NEDA): assenza di recidiva, assenza di progressione confermata dall’EDSS, assenza di lesioni captanti gadolinio in T1, assenza di lesioni nuove/più estese in T2; • progressione della disabilità (definita da un aumento di almeno 1 punto nella scala EDSS) dal basale (SD1) alla Settimana 48. • percentuale di disabilità confermata (variazione dell’EDSS ≥ 1,5 punti in pazienti con EDSS = 0, variazione dell’EDSS ≥ +1,0 punti in pazienti con EDSS > 0 e < 5,5 o variazione dell’EDSS ≥ +0,5 punti nei pazienti con EDSS ≥ 5,5 confermata dopo 3 mesi) dal basale (SD1) alla Settimana 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -MRI scan: SD1, Week 12, Week 16, Week 20, Week 24, and Week 48 -Relapse: Week 24 and Week 48 -AEs, SAEs: entire study -PK: on Days 85, 169, 253 and 337
    - risonanza magnetica:SD1, settimana 12, 16, 20, 24 e 48 - recidiva: settimane 24 e 48 - AE e SAE: tutto lo studio - PK: giorni 85, 169, 253 e 337
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker analysis
    immunogenicità, analisi del biomarcatore
    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 concerned5
    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
    Bulgaria
    Croatia
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Serbia
    Spain
    Ukraine
    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
    Last patient last visit
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial 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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 187
    F.4.2.2In the whole clinical trial 260
    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)
    After the end of the study, as GNbAC1 is not licensed, the study drug will not be available. The subject will receive other treatment and/or have access to other appropriate care by his doctor.
    Al termine dello studio, dato che GNbAC1 non è autorizzato, il farmaco non sarà più disponibile. Il soggetto riceverà altri trattamenti e/o avrà accesso alle cure appropriate da parte del proprio medico.
    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 Decision2016-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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