Clinical trial • Phase III • Neurology|Rare Disease
satralizumab for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Phase III trial of satralizumab for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD).
Overview
- Trial Therapeutic Area
- Neurology|Rare Disease
- Trial Disease
- Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 07-12-2023
- First CTIS Authorization Date
- 31-01-2024
Trial design
Randomised, placebo (matching) - comparator arm is placebo; dose/schedule not specified in provided data-controlled Phase III trial in Italy, Germany, France and others.
- Randomised
- Yes
- Comparator
- Placebo (matching) - comparator arm is placebo; dose/schedule not specified in provided data
- Target Sample Size
- 118
Eligibility
Recruits 118 paediatric patients.
- Pregnancy Exclusion
- 6. For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
- Vulnerable Population
- Vulnerable populations are selected (isVulnerablePopulationSelected: true). The trial includes adolescents (documents include assent and adolescent ICF: e.g. "L1_SIS and ICF Assent_12-17 yr", "L1_SIS and ICF Main adolescent") and infant/parent forms (e.g. "L1_SIS and ICF infant form", parental consent forms). Consent/assent handling documented with age-appropriate informed consent and assent forms and parent/guardian consent forms for minors.
Inclusion criteria
- {"criterion_text":"- 1. Participants who are aged >=12 years at the time of signing Informed Consent Form and confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening\n- 2. Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening\n- 3. High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening\n- 4. Participants receiving either no ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids (OCS) or a combination of OCS and AZA or MMF prior to and at the time of screening\n- 5. No contraindications to rescue treatments and no contraindications to MRI\n- 6. For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab"}
Exclusion criteria
- {"criterion_text":"- 1. Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum\n- 2. History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis\n- 3. Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study\n- 4. Intravenous immunoglobulins (IVIg) or subcutaneous immunoglobulins ( ScIg) within 4 weeks prior to screening\n- 5. Plasma exchange (PLEX) within 4 weeks prior to screening\n- 6. Systemic corticosteroids, AZA or MMF within 4 weeks prior to screening (if not continued as concomitant IST in the study)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)","definition_or_measurement_approach":"Time from randomization to first adjudicated MOGAD relapse during the double-blind treatment period; relapse determination by an adjudication committee (CEC)."}
Secondary endpoints
- {"endpoint_text":"- 1. Rate of adjudicated MOGAD relapses\n- 2. Active lesions on MRI of the neuroaxis (Gd-enhancing or new/enlarging T2 hyperintense lesions measured across the optic nerve, the spinal cord and the brain, including brainstem and cerebellum)\n- 3. Proportion of participants receiving rescue therapy\n- 4. Rate of inpatient hospitalizations (defined as more than an overnight stay, excluding those for elective procedures)\n- 5. Proportion of relapse-free participants at 6-month intervals\n- 6. Change from baseline in total Montreal cognitive assessment (MoCA) score (adolescents only)\n- 7. Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)\n- 8. Change from baseline in targeted vital signs\n- 9. Change from baseline in targeted electrocardiogram (ECG) parameters\n- 10. Change from baseline in targeted clinical laboratory test results\n- 11. Change from baseline in suicidality, as determined by Columbia-Suicide Severity Rating Scale\n- 12. Change from baseline in weight","definition_or_measurement_approach":"1: Rate of adjudicated relapses as determined by adjudication committee. 2: MRI lesions defined as Gd-enhancing or new/enlarging T2 hyperintense lesions measured across optic nerve, spinal cord and brain (including brainstem and cerebellum). 3: Proportion receiving rescue therapy (use captured). 4: Inpatient hospitalizations defined as > overnight stay excluding elective procedures. 5: Relapse-free proportion assessed at 6-month intervals. 6: MoCA change from baseline (adolescents only). 7: AEs graded per NCI CTCAE v5.0. 11: Suicidality assessed by Columbia-Suicide Severity Rating Scale. Other measures are changes from baseline in vitals, ECG, lab results, and weight."}
Recruitment
- Planned Sample Size
- 118
- Recruitment Window Months
- 64
- Consent Approach
- Age-appropriate informed consent and assent process documented. Adolescent assent forms for 12-17 years (e.g. "L1_SIS and ICF Assent_12-17 yr"), parent/guardian consent forms and infant consent forms are provided (e.g. "L1_SIS and ICF infant form", "L1_SIS and ICF parents"). Documents include dedicated materials for adolescents and parents and specific ICF versions (including OLE materials).
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 73
Italy
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 31-01-2024
- Processing Time Days
- 22
- Number Of Sites
- 7
- Number Of Participants
- 22
Sites
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- Neuroscienze cliniche Neuroimmunologia e Malattie Neuromuscolari
- Principal Investigator Name
- Carlo Antozzi
- Principal Investigator Email
- carlo.antozzi@istituto-besta.it
- Contact Person Name
- Carlo Antozzi
- Contact Person Email
- carlo.antozzi@istituto-besta.it
- Site Name
- Bambino Gesu Childrens Hospital
- Department Name
- Neurologia
- Principal Investigator Name
- Massimiliano Valeriani
- Principal Investigator Email
- massimiliano.valeriani@opbg.net
- Contact Person Name
- Massimiliano Valeriani
- Contact Person Email
- massimiliano.valeriani@opbg.net
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Neurologia II
- Principal Investigator Name
- Alessia Di Sapio
- Principal Investigator Email
- a.disapio@sanluigi.piemonte.it
- Contact Person Name
- Alessia Di Sapio
- Contact Person Email
- a.disapio@sanluigi.piemonte.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Clinica Neurologica, Centro Sclerosi Multipla
- 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 Universitaria Integrata Verona
- Department Name
- Neuroscienze Biomedicina e Movimento
- Principal Investigator Name
- Sara Mariotto
- Principal Investigator Email
- sara.mariotto@aovr.veneto.it
- Contact Person Name
- Sara Mariotto
- Contact Person Email
- sara.mariotto@aovr.veneto.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
- Principal Investigator Name
- Massimo Filippi
- Principal Investigator Email
- filippi.massimo@hsr.it
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
- Site Name
- Neurological Institute Foundation Casimiro Mondino
- Department Name
- S.C. Neuroncologia
- Principal Investigator Name
- Matteo Gastaldi
- Principal Investigator Email
- matteo.gastaldi@mondino.it
- Contact Person Name
- Matteo Gastaldi
- Contact Person Email
- matteo.gastaldi@mondino.it
Germany
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 31-01-2024
- Processing Time Days
- 22
- Number Of Sites
- 7
- Number Of Participants
- 22
Sites
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Orhan Aktas
- Principal Investigator Email
- orhan.aktas@med.uni-duesseldorf.de
- Contact Person Name
- Orhan Aktas
- Contact Person Email
- orhan.aktas@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Neurologische Klinik
- Principal Investigator Name
- Lucas Schirmer
- Principal Investigator Email
- lucas.schirmer@medma.uni-heidelberg.de
- Contact Person Name
- Lucas Schirmer
- Contact Person Email
- lucas.schirmer@medma.uni-heidelberg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- NCRC, Clinical Neuroimmunology
- Principal Investigator Name
- Tatiana Usnich
- Principal Investigator Email
- tatiana.usnich@charite.de
- Contact Person Name
- Tatiana Usnich
- Contact Person Email
- tatiana.usnich@charite.de
- Site Name
- Vestische Kinder- und Jugendklinik Datteln
- Department Name
- Neuropaediatrie
- Principal Investigator Name
- Kevin Rostasy
- Principal Investigator Email
- k.rostasy@kinderklinik-datteln.de
- Contact Person Name
- Kevin Rostasy
- Contact Person Email
- k.rostasy@kinderklinik-datteln.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Frank Leypoldt
- Principal Investigator Email
- frank.leypoldt@uksh.de
- Contact Person Name
- Frank Leypoldt
- Contact Person Email
- frank.leypoldt@uksh.de
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Ilya Ayzenberg
- Principal Investigator Email
- ilya.ayzenberg@rub.de
- Contact Person Name
- Ilya Ayzenberg
- Contact Person Email
- ilya.ayzenberg@rub.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Institute of Clinical Neuroimmunology
- Principal Investigator Name
- Tania Kuempfel
- Principal Investigator Email
- Tania.Kuempfel@med.uni-muenchen.de
- Contact Person Name
- Tania Kuempfel
- Contact Person Email
- Tania.Kuempfel@med.uni-muenchen.de
France
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 08-03-2024
- Processing Time Days
- 59
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Bicetre Hospital
- Department Name
- Neurologie Pédiatrique
- Principal Investigator Name
- Kumaran DEIVA
- Principal Investigator Email
- kumaran.deiva@aphp.fr
- Contact Person Name
- Kumaran DEIVA
- Contact Person Email
- kumaran.deiva@aphp.fr
- Site Name
- Hospital Pierre Wertheimer
- Department Name
- Neurologie
- Principal Investigator Name
- Romain MARIGNIER
- Principal Investigator Email
- romain.marignier@chu-lyon.fr
- Contact Person Name
- Romain MARIGNIER
- Contact Person Email
- romain.marignier@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Neurologie
- Principal Investigator Name
- Jonathan CIRON
- Principal Investigator Email
- ciron.j@chu-toulouse.fr
- Contact Person Name
- Jonathan CIRON
- Contact Person Email
- ciron.j@chu-toulouse.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 04-05-2025
- Processing Time Days
- 39
- Number Of Sites
- 7
- Number Of Participants
- 18
Sites
- Site Name
- Instytut Pomnik Centrum Zdrowia Dziecka
- Department Name
- Klinika Neurologii i Epileptologii
- Principal Investigator Name
- Katarzyna Kotulska-Jóźwiak
- Principal Investigator Email
- oddzial.neurologia@ipczd.pl
- Contact Person Name
- Katarzyna Kotulska-Jóźwiak
- Contact Person Email
- oddzial.neurologia@ipczd.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Zespół Poradni Specjalistycznych - Botaniczna 3
- Principal Investigator Name
- Agnieszka Słowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieszka Słowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski
- Principal Investigator Name
- Lech Szczechowski
- Principal Investigator Email
- lszczechowski@gmail.com
- Contact Person Name
- Lech Szczechowski
- Contact Person Email
- lszczechowski@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Klinika Neurologii
- Principal Investigator Name
- Beata Zakrzewska-Pniewska
- Principal Investigator Email
- kn.csk@uckwum.pl
- Contact Person Name
- Beata Zakrzewska-Pniewska
- Contact Person Email
- kn.csk@uckwum.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Oddział Neurologiczny
- Principal Investigator Name
- Monika Adamczyk-Sowa
- Principal Investigator Email
- neurozab@sum.edu.pl
- Contact Person Name
- Monika Adamczyk-Sowa
- Contact Person Email
- neurozab@sum.edu.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o. S.K.
- Principal Investigator Name
- Halina Bartosik-Psujek
- Principal Investigator Email
- badaniakliniczne@medyk.rzeszow.pl
- Contact Person Name
- Halina Bartosik-Psujek
- Contact Person Email
- badaniakliniczne@medyk.rzeszow.pl
- Site Name
- Neurocentrum Bydgoszcz Sp. z o.o.
- Principal Investigator Name
- Robert Bonek
- Principal Investigator Email
- wyniki@ncbydgoszcz.pl
- Contact Person Name
- Robert Bonek
- Contact Person Email
- wyniki@ncbydgoszcz.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Monitoring
- Name
- Ixico Technologies Limited
- Responsibilities
- Medical image analysis/review - MRI, Ultrasound, etc
- Name
- Signant Health Global LLC
- Responsibilities
- Primary/Surrogate Endpoint Test, Centralized Adjudication of Primary Endpoint, Management of clinical outcome assessments instruments
- Name
- Labcorp Central Laboratory Services S.a.r.l.
- Responsibilities
- Provision of Kits, Logistics Services, Clinical Haematology, Clinical Chemistry
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Ixico Technologies Limited","duties_or_roles":"Medical image analysis/review - MRI, Ultrasound, etc","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Primary/Surrogate Endpoint Test, Centralized Adjudication of Primary Endpoint, Management of clinical outcome assessments instruments","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Provision of Kits, Logistics Services, Clinical Haematology, Clinical Chemistry","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Satralizumab (RO 533-3787/F01)
- Active Substance
- satralizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- EU/1/21/1559/001 (marketing authorisation present in product information)
- Orphan Designation
- Yes
- Investigational Product Name
- RO 533-3787/F01-06 (satralizumab product variant)
- Active Substance
- satralizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- PRD10948861 (product record present; prodAuthStatus indicated)
- Combination Treatment
- Yes
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