Clinical trial • Phase IV • Neurology
LIVE BCG BACILLI (BACILLUS CALMETTE-GUERIN), BRASILIAN MOREAU SUBSTRAIN for Radiologically isolated syndrome
Phase IV trial of LIVE BCG BACILLI (BACILLUS CALMETTE-GUERIN), BRASILIAN MOREAU SUBSTRAIN for Radiologically isolated syndrome.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Radiologically isolated syndrome
- Trial Stage
- Phase IV
- Drug Modality
- Vaccine | Small molecule
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 27-11-2024
Trial design
Randomised, test arm: bcg 10 anti-tuberculosis vaccine (live bcg bacilli, brasilian moreau substrain), single intradermal dose (study day 1), product specification indicates up to 50 µl. comparator arm: placebo - sodio cloruro s.a.l.f. 0,9% (sodium chloride), intradermal, matched volume (up to 50 µl) single dose on day 1.-controlled Phase IV trial across 21 sites in Italy.
- Randomised
- Yes
- Comparator
- Test Arm: BCG 10 Anti-Tuberculosis Vaccine (live BCG bacilli, Brasilian Moreau substrain), single intradermal dose (study day 1), product specification indicates up to 50 µl. Comparator arm: Placebo - Sodio cloruro S.A.L.F. 0,9% (sodium chloride), intradermal, matched volume (up to 50 µl) single dose on Day 1.
- Target Sample Size
- 100
- Trial Duration For Participant
- 1095
Eligibility
Recruits 100 Vulnerable population flag set (isVulnerablePopulationSelected = true). All participants must provide Signed Informed Consent; participants are adults (> 18 years old) so assent is not applicable. Subject information and informed consent form documents are included in the submission..
- Pregnancy Exclusion
- Pregnancy or lactation.
- Vulnerable Population
- Vulnerable population flag set (isVulnerablePopulationSelected = true). All participants must provide Signed Informed Consent; participants are adults (> 18 years old) so assent is not applicable. Subject information and informed consent form documents are included in the submission.
Inclusion criteria
- {"criterion_text":"- Male and female of any race and > 18 years old."}
- {"criterion_text":"- Diagnosis of RIS (4) within the last five years."}
- {"criterion_text":"- Signed Informed Consent."}
Exclusion criteria
- {"criterion_text":"- Pregnancy or lactation."}
- {"criterion_text":"- Concomitant or previous use of immunosuppressive or immunomodulating treatment (except sporadic use of corticosteroids) within the last five years."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Subjects with inability to successfully undergo MRI scans."}
- {"criterion_text":"- Concomitant radiotherapy."}
- {"criterion_text":"- Known hypersensitivity to any component of the vaccine."}
- {"criterion_text":"- Past bone marrow stem cell transplantation and organ transplantation."}
- {"criterion_text":"- Other vaccinations in the previous 4 weeks."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of the study will be the cumulative number of CUAL on MRI scans over 1 year.","definition_or_measurement_approach":"CUAL defined as new gadolinium T1-weighted and T2-weighted new and newly non-enhancing expansion; measured on MRI scans over 1 year."}
Secondary endpoints
- {"endpoint_text":"- Time to first clinical event within the 3-year period.","definition_or_measurement_approach":"Time from randomisation/treatment to first clinical event, evaluated over a 3-year follow-up period."}
- {"endpoint_text":"- Exploraty endpoints: - Number of cortical lesions - Percentage of Brain Volume Changes (PBVC) - Changes in volume of cortex and White matter - Magnetization transfer ratio (MTr) in lesions - MTr in normal-looking brain","definition_or_measurement_approach":"Exploratory MRI-derived measures assessed at specified timepoints (6 months and at 1, 2 and 3 years) including counts of cortical lesions, PBVC, cortical and white matter volume changes, and MTr in lesions and normal-appearing brain."}
- {"endpoint_text":"- Safety / tolerability endpoints: Adverse events occurring during the study and laboratory tests","definition_or_measurement_approach":"Safety assessed by collection of adverse events and laboratory test results during the study."}
Other endpoints
- {"endpoint_text":"- Number of cortical lesions","definition_or_measurement_approach":"MRI assessment at 6 months and at 1, 2 and 3 years."}
- {"endpoint_text":"- Percentage of Brain Volume Changes (PBVC)","definition_or_measurement_approach":"PBVC measured on MRI at 6 months and at 1, 2 and 3 years."}
- {"endpoint_text":"- Changes in volume of cortex and White matter","definition_or_measurement_approach":"Cortical and white matter volume changes measured on MRI at 6 months and at 1, 2 and 3 years."}
- {"endpoint_text":"- Magnetization transfer ratio (MTr) in lesions","definition_or_measurement_approach":"MTr in lesions measured on MRI at 6 months and at 1, 2 and 3 years."}
- {"endpoint_text":"- MTr in normal-looking brain","definition_or_measurement_approach":"MTr in normal-appearing brain measured on MRI at 6 months and at 1, 2 and 3 years."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 84
- Consent Approach
- Signed informed consent required from each participant (inclusion criterion: 'Signed Informed Consent.'). Participants are adults (>18). Subject information and informed consent form documents are included in the submission (L1 documents); Italian translation(s) are present in the submission materials.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 100
Italy
- Earliest CTIS Part Ii Submission Date
- 22-10-2024
- Latest Decision Or Authorization Date
- 27-11-2024
- Processing Time Days
- 36
- Number Of Sites
- 21
- Number Of Participants
- 100
Sites
- Site Name
- Careggi University Hospital
- Department Name
- SOD di Neurologia 1
- Principal Investigator Name
- Maria Pia Amato
- Principal Investigator Email
- mariapia.amato@unifi.it
- Contact Person Name
- Maria Pia Amato
- Contact Person Email
- mariapia.amato@unifi.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Dipartimento Testa Collo - UOSD Malattie Degenerative Sistema Nervoso
- Principal Investigator Name
- Claudio Gasperini
- Principal Investigator Email
- cgasperini@scamilloforlanini.rm.it
- Contact Person Name
- Claudio Gasperini
- Contact Person Email
- cgasperini@scamilloforlanini.rm.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Centro Sclerosi Multipla -I Clinica Neurologica
- Principal Investigator Name
- Antonio Gallo
- Principal Investigator Email
- antonio.gallo@unicampania.it
- Contact Person Name
- Antonio Gallo
- Contact Person Email
- antonio.gallo@unicampania.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- DINOGMI)
- Principal Investigator Name
- Matilde Inglese
- Principal Investigator Email
- m.inglese@unige.it
- Contact Person Name
- Matilde Inglese
- Contact Person Email
- m.inglese@unige.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- Centro Sclerosi Multipla - UOC Neurologia Universitaria
- Principal Investigator Name
- Carlo Avolio
- Principal Investigator Email
- carlo.avolio@unifg.it
- Contact Person Name
- Carlo Avolio
- Contact Person Email
- carlo.avolio@unifg.it
- Site Name
- Fondazione Istituto G. Giglio Di Cafalu
- Department Name
- UO di Neurologia
- Principal Investigator Name
- Luigi Grimaldi
- Principal Investigator Email
- luigi.grimaldi@hsrgiglio.it
- Contact Person Name
- Luigi Grimaldi
- Contact Person Email
- luigi.grimaldi@hsrgiglio.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- Centro Sclerosi Multipla - UO di Neurologia
- Principal Investigator Name
- Francesco Patti
- Principal Investigator Email
- patti@unict.it
- Contact Person Name
- Francesco Patti
- Contact Person Email
- patti@unict.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- - Centro per la Sclerosi Multipla
- Principal Investigator Name
- Gerolama Marfia
- Principal Investigator Email
- marfia@med.uniroma2.it
- Contact Person Name
- Gerolama Marfia
- Contact Person Email
- marfia@med.uniroma2.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- entro Sclerosi - Multipla UO di Neurologia
- Principal Investigator Name
- Roberta Lanzillo
- Principal Investigator Email
- roberta.lanzillo@unina.it
- Contact Person Name
- Roberta Lanzillo
- Contact Person Email
- roberta.lanzillo@unina.it
- Site Name
- Siena University
- Department Name
- AOU Senese-Scienze neurologiche e neurosensoriali - UO Neurologia sperimentale
- Principal Investigator Name
- Nicola De Stefano
- Principal Investigator Email
- destefano@unisi.it
- Contact Person Name
- Nicola De Stefano
- Contact Person Email
- destefano@unisi.it
- Site Name
- Istituto Neurologico Mediterraneo Neuromed S.p.A.
- Department Name
- Neurologia Generale e Disturbi del Movimento - UOC Neurologia I
- Principal Investigator Name
- Diego Centonze
- Principal Investigator Email
- centonze@uniroma2.it
- Contact Person Name
- Diego Centonze
- Contact Person Email
- centonze@uniroma2.it
- Site Name
- Azienda Socio Sanitaria Territoriale Della Valle Olona
- Department Name
- PO Gallarate - Centro Studi Sclerosi Multipla - Neurologia 2 - Recupero Neurologico
- Principal Investigator Name
- Pietro Annovazzi
- Principal Investigator Email
- pietro.annovazzi@asst-valleolona.it
- Contact Person Name
- Pietro Annovazzi
- Contact Person Email
- pietro.annovazzi@asst-valleolona.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- UO di Neurologia IV
- Principal Investigator Name
- Paolo Agostino Confalonieri
- Principal Investigator Email
- paolo.confalonieri@istituto-besta.it
- Contact Person Name
- Paolo Agostino Confalonieri
- Contact Person Email
- paolo.confalonieri@istituto-besta.it
- Site Name
- University Of Bari Aldo Moro
- Department Name
- AOU Consorziale Policlinico di Bari -UOC di Neurofisiopatologia
- Principal Investigator Name
- Damiano Paolicelli
- Principal Investigator Email
- damiano.paolicelli@uniba.it
- Contact Person Name
- Damiano Paolicelli
- Contact Person Email
- damiano.paolicelli@uniba.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- Neurologia - Centro Sclerosi Multipla
- Principal Investigator Name
- Giorgia Maniscalco
- Principal Investigator Email
- gtmaniscalco@libero.it
- Contact Person Name
- Giorgia Maniscalco
- Contact Person Email
- gtmaniscalco@libero.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC di Neurologia
- Principal Investigator Name
- Massimiliano Mirabella
- Principal Investigator Email
- mirabella@rm.unicatt.it
- Contact Person Name
- Massimiliano Mirabella
- Contact Person Email
- mirabella@rm.unicatt.it
- Site Name
- Azienda Sanitaria Locale Roma 1
- Department Name
- P.O. San Filippo Neri -Dipartimento Medico e di Riabilitazione - UOC di Neurologia
- Principal Investigator Name
- Elisabetta Ferraro
- Principal Investigator Email
- ae.ferraroi@sanfilipponeri.roma.it
- Contact Person Name
- Elisabetta Ferraro
- Contact Person Email
- ae.ferraroi@sanfilipponeri.roma.it
- Site Name
- Azienda Socio Sanitaria Locale N. 8 Di Cagliari
- Department Name
- Ospedale “R. Binaghi" - Centro Sclerosi Multipla
- Principal Investigator Name
- Jessica Frau
- Principal Investigator Email
- jessicafrau@hotmail.it
- Contact Person Name
- Jessica Frau
- Contact Person Email
- jessicafrau@hotmail.it
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- IRCCS Istituto delle Scienze Neurologiche di Bologna - UOSI Riabilitazione Sclerosi Multipla
- Principal Investigator Name
- Alessandra Lugaresi
- Principal Investigator Email
- alessandra.lugaresi2@unibo.it
- Contact Person Name
- Alessandra Lugaresi
- Contact Person Email
- alessandra.lugaresi2@unibo.it
- Site Name
- Universita Degli Studi Di Roma La Sapienza
- Department Name
- AO S. Andrea - Centro Neurologico Terapie Sperimentali - UOC di Neurologia
- Principal Investigator Name
- Giovanni Ristori
- Principal Investigator Email
- giovanni.ristori@uniroma1.it
- Contact Person Name
- Giovanni Ristori
- Contact Person Email
- giovanni.ristori@uniroma1.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Neurologia B
- Principal Investigator Name
- Massimiliano Calabrese
- Principal Investigator Email
- massimiliano.Calabrese@univr.it
- Contact Person Name
- Massimiliano Calabrese
- Contact Person Email
- massimiliano.Calabrese@univr.it
Sponsor
Primary sponsor
- Full Name
- Fondazione Italiana Sclerosi Multipla Ente Del Terzo Settore/et S
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- BCG 10 Anti-Tuberculosis Vaccine, Powder and solvent for suspension for intradermal injection Vaccinum tuberculosis (BCG) cryodesiccatum
- Active Substance
- LIVE BCG BACILLI (BACILLUS CALMETTE-GUERIN), BRASILIAN MOREAU SUBSTRAIN
- Modality
- Vaccine
- Routes Of Administration
- Intradermal
- Route
- Intradermal
- Authorisation Status
- Authorised (marketing authorisation AA1379/00301 in MT)
- Starting Dose
- Single intradermal dose, up to 50 µl
- Frequency
- Single dose on Day 1
- Maximum Dose
- 50 µl
- Investigational Product Name
- Sodio cloruro S.A.L.F. 0,9% solvente per uso parenterale.
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intradermal
- Route
- Intradermal
- Authorisation Status
- Authorised (marketing authorisation 030684411 in IT)
- Starting Dose
- Single intradermal matched-volume placebo, up to 50 µl
- Frequency
- Single dose on Day 1
- Maximum Dose
- 50 µl
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