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    Summary
    EudraCT Number:2018-000736-10
    Sponsor's Protocol Code Number:BCG-RIS-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000736-10
    A.3Full title of the trial
    “Bacille Calmette-Guérin (BCG) vaccine In Radiologically Isolated Syndrome (Ris)”
    “Vaccino Bacille Calmette-Guérin (BCG) nella Sindrome Radiologicamente Isolata (Ris)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    “Bacille Calmette-Guérin (BCG) vaccine In Radiologically Isolated Syndrome (Ris)”
    “Vaccino Bacille Calmette-Guérin (BCG) nella Sindrome Radiologicamente Isolata (Ris)”
    A.3.2Name or abbreviated title of the trial where available
    Not available
    Non disponibile
    A.4.1Sponsor's protocol code numberBCG-RIS-01
    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 SponsorFONDAZIONE ITALIANA SCLEROSI MULTIPLA ONLUS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFondazione Italiana Sclerosi Multipla
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera S. Andrea di Roma
    B.5.2Functional name of contact pointCentro Neurologico Terapie Sperimen
    B.5.3 Address:
    B.5.3.1Street AddressVia di Grotta Rossa, 1035
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number0633776044
    B.5.5Fax number0633775076
    B.5.6E-mailcenterdh@gmail.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 Yes
    D.2.1.1.1Trade name BCG 10 Anti-Tuberculosis Vaccine
    D.2.1.1.2Name of the Marketing Authorisation holder“BIOMED-LUBLIN” Wytwórnia Surowic i Szczepionek Spólka Akcyjna
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameBCG 10 Anti-Tuberculosis Vaccine
    D.3.2Product code [Non Disponibile]
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBCG - BACILLO DI CALMETTE E GUERIN
    D.3.9.2Current sponsor codeVaccinum tuberculosis (BCG) cryodesiccatum
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolvent for parenteral use
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Radiologically Isolated Syndrome (Ris)
    RIS (Sindrome Radiologicamente Isolata)
    E.1.1.1Medical condition in easily understood language
    Condition characterized by presence of brain white matter lesions visible with magnetic resonance imaging (MRI) suggestive of MS without clinical symptoms
    Condizione caratterizzata dalla presenza alla risonanza magnetica di lesioni della sostanza bianca encefalica suggestive di sclerosi multipla in assenza di sintomatologia clinica
    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 10079292
    E.1.2Term Radiologically isolated syndrome
    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 evaluate the cumulative number of new combined unique active lesions (CUAL; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over 1 year.
    Valutare il numero cumulativo di nuove lesioni attive uniche combinate (CUAL; definito come nuove lesioni gadolinio T1-ponderate e lesioni T2 ponderate nuove e di nuova espansione non migliorative) su scansioni di risonanza magnetica (MRI) nell’arco di 1 anno.
    E.2.2Secondary objectives of the trial
    Secondary objectives: To evaluate the time to the first clinical event over the 3 years period.
    Exploratory secondary objectives
    - to evaluate the number of cortical lesions at 6 months, as well as at 1, 2 and 3 years;
    - to evaluate the Percentage of Brain Volume Changes (PBVC) at 6 months, as well as at 1, 2 and 3 years;
    - to evaluate the Cortical and white matter Volume Changes at 6 months, as well as at 1, 2 and 3 years;
    - to evaluate the Magnetization Transfer ratio (MTr) in lesions at 6 months, as well as at 1, 2 and 3 years;
    - to evaluate the Magnetization Transfer ratio (MTr) in normal-appearing brain at 6 months, as well as at 1, 2 and 3 years;
    - to evaluate the immune-metabolic profile at 6 months, as well as at 1, 2 and 3 years.
    Safety objectives
    To evaluate the overall safety and tolerability profile of BCG 10 Anti-Tuberculosis Vaccine administered intradermally in subjects with RIS diagnosis.
    Obiettivi Secondari: Valutare il tempo al primo evento clinico nell’arco dei 3 anni.
    Obiettivi Secondari esplorativi
    - valutare il numero di lesioni corticali a 6 mesi, così come a 1, 2 e 3 anni;
    - valutare la Percentuale di Variazioni del Volume del Cervello (PBVC) a 6 mesi, così come a 1, 2 e 3 anni;
    - valutare le variazioni di volume della corteccia e della materia Bianca a 6 mesi, così come a 1, 2 e 3 anni;
    - valutare il rapporto di trasferimento della magnetizzazione (MTr) in lesioni a 6 mesi, così come a 1, 2 e 3 anni;
    - valutare il rapporto di trasferimento della magnetizzazione (MTr) in cervello dall’aspetto normale a 6 mesi, così come a 1, 2 e 3 anni;
    - valutare il profilo immuno-metabolico a 6 mesi, così come a 1, 2 e 3 anni;
    Obiettivi di sicurezza
    Valutare la sicurezza generale e il profilo di tollerabilità del vaccino BCG 10 Anti-Tubercolosi somministrato per via intradermica in soggetti con diagnosi di RIS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female of any race and > 18 years old.
    2. Diagnosis of RIS (4) within the last five years.
    3. Signed Informed Consent.
    1. Individui si sesso maschile e femminile di qualsiasi razza > 18 anni di età.
    2. Diagnosi di RIS (4) negli ultimi cinque anni.
    3. Consenso Informato firmato.
    E.4Principal exclusion criteria
    1. Pregnancy or lactation.
    2. Concomitant or previous use of immunosuppressive or immunomodulating treatment (except sporadic use of corticosteroids) within the last five years.
    3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, severe systemic mycotic infections, metabolic diseases or malignancies, primary or secondary immunodeficiencies as determined by medical history, physical exam, laboratory tests, chest X-ray, electrocardiogram (ECG), and Mantoux reaction or quantiferon test.
    4. Any medical or psychiatric condition that may affect the subjects ability to give informed consent, or to complete the study, or if the subject is considered by the treating neurologist to be, for any other reason, an unsuitable candidate for this study.
    5. Subjects with inability to successfully undergo MRI scans.
    6. Concomitant radiotherapy.
    7. Known hypersensitivity to any component of the vaccine.
    8. Past bone marrow stem cell transplantation and organ transplantation.
    9. Other vaccinations in the previous 4 weeks.
    1. Gravidanza o allattamento.
    2. Utilizzo concomitante o precedente di trattamento immunosoppressivo o immunomodulante (eccetto sporadico utilizzo di corticosteroidi) negli ultimi cinque anni.
    3. Soggetti con un problema medico o chirurgico clinicamente significativo o instabile che potrebbe precludere una partecipazione sicura e completa allo studio. Tali problematiche possono essere di tipo cardiovascolare, polmonare, epatico, renale, o gravi infezioni micotiche sistemiche, malattie metaboliche o neoplasie, immunodeficienze primarie o secondarie come determinato da storia medica, esame fisico, test di laboratorio, raggi X toracici, elettrocardiogramma (ECG) e test di Mantoux o quantiferon test..
    4. Qualsiasi condizione medica o psichiatrica che possa influire sulla capacità del soggetto di fornire il consenso informato, o di completare lo studio, o se il soggetto, per qualsiasi altra motivazione, è considerato un candidato inadeguato per lo studio da parte del neurologo di riferimento.
    5. Soggetti con incapacità a sottoporsi con successo a risonanza magnetica.
    6. Radioterapia concomitante.
    7. Ipersensibilità nota a uno dei componenti del vaccino.
    8. Storia passata di trapianto di cellule staminali del midollo e trapianto di organi.
    9. Altre vaccinazioni nelle precedenti 4 settimane.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be the cumulative number of CUAL on MRI scans over 1 year.
    L’endpoint primario dello studio sarà il numero totale di CUAL nelle scansioni di MRI nell’arco di 1 anno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 1 year (12 months)
    Nell’arco di 1 anno (12 mesi)
    E.5.2Secondary end point(s)
    The time to the first clinical event over the 3 years period.; Exploratory endpoints:
    - Number of cortical lesions
    - Percentage of Brain Volume Changes (PBVC)
    - Cortical and white matter Volume Changes
    - Magnetization Transfer ratio (MTr) in lesions
    - MTr in normal-appearing brain
    - The immune-metabolic profile; Safety / tolerability endpoints: Adverse events occurring during the study and laboratory tests
    Il tempo al primo evento clinico nell’arco dei 3 anni.; Endpoint esplorativi:
    - Numero di lesioni corticali
    - Percentuale di Variazioni del Volume del Cervello (PBVC)
    - Variazioni di volume della corteccia e della materia Bianca
    - Rapporto di trasferimento della magnetizzazione (MTr) nelle lesioni
    - MTr in cervello dall’aspetto normale
    - Il profilo immuno-metabolico; Endpoint di sicurezza / tollerabilità: Eventi avversi verificatisi durante lo studio e test di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the 3 years period.; The exploratory endpoints will be analyzed at 6 months, as well as at 1, 2 and 3 years; Any time during the whole study
    Nell’arco dei 3 anni.; Gli endpoint esplorativi saranno analizzati a 6 mesi, così come a 1, 2 e 3 anni; A qualunque tempo durante l'intero studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned26
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    None
    Nessuno
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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
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