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    Summary
    EudraCT Number:2016-004935-18
    Sponsor's Protocol Code Number:GNC-004
    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:2021-01-22
    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 number2016-004935-18
    A.3Full title of the trial
    A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis
    Studio di estensione a lungo termine, internazionale dello studio GNC-003 con GNbAC1 in pazienti affetti da sclerosi multipla remittente recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis
    Studio clinico per determinare la sicurezza a lungo termine di GNbAC1 in pazienti affetti da sclerosi multipla
    A.3.2Name or abbreviated title of the trial where available
    ANGEL-MS
    ANGEL-MS
    A.4.1Sponsor's protocol code numberGNC-004
    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 1216161
    B.5.5Fax number+44 207 1216160
    B.5.6E-mailgisella.genovese@worldwide.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGNbAC1
    D.3.2Product code GNbAC1
    D.3.4Pharmaceutical form Solution for 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.3.9.1CAS 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 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 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
    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 21.1
    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
    The primary objective is to assess the long term safety of GNbAC1 in patients with RRMS.
    L¿obiettivo primario ¿ la valutazione della sicurezza a lungo termine di GNbAC1 in pazienti affetti da SMRR.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.
    Gli obiettivi secondari sono la valutazione dell¿efficacia a lungo termine di GNbAC1 in termini di esiti osservati alla RM, tasso di recidiva, disabilit¿ e progressione della malattia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study;
    - Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
    -I pazienti devono aver completato il Periodo 2 dello studio GNC 003 e devono soddisfare i criteri di eleggibilità per lo studio GNC 004;
    -I pazienti (potenzialmente fertili di entrambi i sessi) devono accettare di far uso di metodi contraccettivi altamente efficaci
    E.4Principal exclusion criteria
    - Patients not having completed study GNC-003.
    - Emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms.
    - Any major medical or psychiatric disorder that could put the patient at undue risk during the study, according to the investigator's opinion, or that would affect the capacity of the patient to fulfill the requirements of the study, including: Schizophrenia, bipolar disorder, or major depressive disorder, History of suicide attempt, or current suicidal
    ideation, current alcohol or drug abuse.
    - Body weight<40kg
    - Patients not able to follow study instructions, or not able to follow the study assessments defined by the protocol.
    - Forbidden concomitant treatments
    - Legal incapacity or limited legal capacity.
    - Pregnancy.
    - Female patients of childbearing potential (FPCBP) or procreative male patients (PMP), not willing to use highly effective contraceptive methods
    throughout the study duration and at least until 5 months after the last study treatment.
    - Pazienti che non hanno completato lo studio GNC 003.
    - Diagnosi di qualsiasi malattia diversa dalla sclerosi multipla emergente durante lo svolgimento dello studio GNC 003, che potrebbe spiegare in modo migliore i segni e i sintomi neurologici del paziente.
    -- Qualsiasi patologia medica maggiore o disturbo psichiatrico maggiore che, secondo l’opinione dello sperimentatore, esporrebbe il paziente a un rischio eccessivo durante lo studio o che influirebbe sulla capacità del paziente di soddisfare i requisiti dello studio, tra cui: schizofrenia, disturbo bipolare o disturbo depressivo maggiore, anamnesi di tentativi di suicidio o attuale ideazione suicidaria, attuale abuso d’alcol o di sostanze.
    - Peso corporeo = 40 kg.
    - Pazienti non in grado di aderire alle istruzioni o alle valutazioni dello studio definite dal protocollo.
    -Terapie concomitanti non ammesse
    - Incapacità legale o limitata capacità legale.
    - Gravidanza.
    - Partecipanti femmine potenzialmente fertili o partecipanti maschi in grado di procreare non disposti a far uso di metodi contraccettivi altamente efficaci per l’intera durata dello studio e per almeno 5 mesi dopo la somministrazione dell’ultima dose del trattamento in studio.
    E.5 End points
    E.5.1Primary end point(s)
    The following parameters will be evaluated to assess the long term safety of GNbAC1:
    - Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs);
    - Clinical safety laboratory (Haematology, Chemistry, Coagulation) and urine pregnancy test;
    - IgG4 dosing;
    - Physical examination and vital signs: Blood pressure, heart rate, temperature, and body weight;
    - 12-lead ECG;
    - Human anti-GNbAC1 antibodies in serum;
    - Suicidality assessed with the Columbia Suicide Severity Rating Scale (C-SSRS).
    I seguenti parametric saranno valutati per determinare la sicurezza a lungo termine di GNbAC1:
    - Eventi avversi (AE) segnalati spontaneamente ad ogni visita ed eventi avversi seri (SAE)
    - Analisi cliniche di laboratorio per la valutazione della sicurezza (ematologia, chimica clinica, coagulazione) e test di gravidanza nelle urine
    - Somministrazione di IgG4
    - Esame obiettivo e parametric vitali: pressione arteriosa, frequenza cardiaca, temperatura e peso corporeo
    - ECG a 12 derivazioni
    - Anticorpi umani anti GNbAC1 nel siero
    - Valutazione della suicidabilità determinata mediante la scala C-SSRS (Columbia Suicide Severity Rating Scale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - AEs at each visit; SAEs at any time
    - Laboratory parameters every 6 months and urine pregnancy test at each study visit
    - Physical examination and vital signs at selection and at each study visit
    - C-SSRS at every visit
    - ECG and human anti-GNbAC1 antibodies every 6 months
    - IgG4 at baseline, W48 and W96
    - Eventi avversi (AE) ad ogni visita; eventi avversi seri (SAE) in qualsiasi momento
    - Parametri di laboratorio ogni 6 mesi e test di gravidanza nelle urine ad ogni visita dello studio
    - Esame obiettivo e parametri vitali alla visita di inclusione e ad ogni visita della studio
    - C-SSRS ad ogni visita
    E.5.2Secondary end point(s)
    The following parameters will be evaluated to assess the long term efficacy of GNbAC1:
    - Brain MRI markers of inflammation, disease progression, demyelination and remyelination;
    - Annualized relapse rate;
    - Proportion of patients with confirmed neurological disability worsening (defined as an increase of = 1.5 step on the EDSS for EDSS= 0; increase of = 1 step on the EDSS from EDSS > 0 and < 5.5; and =0.5 EDSS steps from EDSS = 5.5, confirmed after at least 3 months at scheduled clinic visits)
    - Proportion of patients with confirmed neurological disability improvement (defined as a decrease of at least 1 step on the EDSS from EDSS =1 and < 5.5and decrease of at least 0.5 EDSS steps from EDSS = 5.5, confirmed after at least 3 months at scheduled clinic visits)
    - Proportion of patients with No Evidence of Disease Activity (NEDA, defined as absence of new T1 or T2 lesions on MRI scan, absence of relapse and absence of confirmed disability worsening at Week 48 and 96);
    - Time to confirmed neurological disability worsening (as defined above);
    - Time to confirmed neurological disability improvement (as defined above);
    - EDSS change from baseline in GNC-003 study;
    - MSFC scores (including subcomponent scores) change from baseline in GNC-003 study.
    I seguenti parametric saranno valutati per determinare l'efficacia a lungo termine di GNbAC1:
    - Marker di infiammazione, progressione della malattia, demielinazione e rimielinazione rilevati con la risonanza magnetica dell¿encefalo
    - Tasso di recidiva annualizzato
    - Percentuale di pazienti con peggioramento confermato della disabilit¿ neurologica (definito come un aumento = 1,5 punti nella scala EDSS nel caso di EDSS = 0; aumento = 1 punto nell¿EDSS dall¿EDSS > 0 e < 5,5; e = 0,5 punti dell¿EDSS dall¿EDSS = 5,5, confermato dopo almeno 3 mesi alle visite ambulatoriali programmate)
    - Percentuale di pazienti con miglioramento confermato della disabilit¿ neurologica (definito come una riduzione di almeno 1 punto nella scala EDSS dall¿EDSS = 1 e < 5,5 e una riduzione di almeno 0,5 punti nell¿EDSS dall¿EDSS = 5,5, confermato dopo almeno 3 mesi alle visite ambulatoriali programmate)
    - Percentuale di pazienti con nessuna evidenza di attivit¿ della malattia (No Evidence of Disease Activity, NEDA: definita come assenza di nuove lesioni in T1 o T2 rilevate alla RM, assenza di recidiva, assenza di peggioramento della disabilit¿ confermato alle settimane 48 e 96
    - Tempo al peggioramento confermato della disabilit¿ neurologica (come sopra definito).
    - Tempo al miglioramento confermato della disabilit¿ neurologica (come sopra definito).
    - Variazione dell¿EDSS dal basale dello studio GNC 003
    - Variazione dei punteggi della scala MSFC (inclusi i punteggi delle sottocomponenti) dal basale dello studio GNC 003
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Annualized relapse rate from baseline in GNC-003 to Weeks 48 and from weeks 48 to weeks 96
    - EDSS and MSFC at Weeks 24, 48, 72 and 96
    - Proportion of patients with confirmed neurological disability worsening or improvement from baseline in GNC-003 study to weeks 24, 48, 72 and 96
    - Tasso di recidiva annualizzato dal basale dello studio GNC 003 alla settimana 48 e dalla settimana 48 alla settimana 96
    - EDSS e MSFC alle settimane 24, 48, 72 e 96
    - Percentuale di pazienti con peggioramento o miglioramento confermato della disabilit¿ neurologica dal basale dello studio GNC 003 alle settimane 24, 48, 72 e 96
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, biomarkers analysis
    Immunogenicit¿, analisi dei biomarcatori
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    nessun comparatore
    no comparator
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nessun comparatore
    no comparator
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Russian Federation
    Serbia
    Ukraine
    Bulgaria
    Croatia
    Czechia
    Estonia
    Germany
    Hungary
    Italy
    Poland
    Spain
    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 years2
    E.8.9.1In the Member State concerned months9
    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 months9
    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: 200
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 200
    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, poich¿ GNbAC1 non ¿ autorizzato, il farmaco in studio non sar¿ disponibile. I soggetti riceveranno altri trattamenti e/o avranno 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 Decision2017-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-14
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