A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

In brief

The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.

Key facts

Study ID

NCT05271409

Run by

Hoffmann-La Roche

People needed

152

Starts

2022-08-30

Expected to finish

2028-05-20

Last updated by the study team

2026-08-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who are aged >=12 years at the time of signing Informed Consent Form
• 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
• Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
• High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening
• Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
• 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

You may not qualify if…

• Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum
• History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
• Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses > 20 milligrams (mg) prednisone equivalent per day for >21 days during the study
• Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
• Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
• Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
• Participants with positive screening tests for hepatitis B and C
• Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
• History of severe allergic reaction to a biologic agent

Where it is running

• Centro de Pesquisas Clinicas — São Paulo, São Paulo, Brazil
• Hospital Universitario Gaffree e Guinle — Rio de Janeiro, Brazil
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
• MUCH - Montreal Neurological Institute & Hospital — Montreal, Quebec, Canada
• Hopital Pierre Wertheimer — Bron, France
• CH de Bicêtre — Le Kremlin-Bicêtre, France
• ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic — Berlin, Germany
• St. Josef-Hospital, Klinik für Neurologie — Bochum, Germany
• Vestische Kinder- und Jugendklinik Datteln — Datteln, Germany
• Universitätsklinikum Düsseldorf — Düsseldorf, Germany
• Universitätsklinikum Mannheim — Mannheim, Germany
• Klinikum Großhadern, LMU — Munich, Germany
• Hadassah University Hospital Ein Kerem — Jerusalem, Israel
• Fondazione Istituto Neurologico Mondino IRCCS — Pavia, Lombardy, Italy
• Azienda Sanitaria Ospedaliera S. Luigi Gonzaga — Orbassano, Piedmont, Italy
• Azienda Ospedaliera Universitaria Integrata Verona — Verona, Veneto, Italy
• Chiba University Hospital — Chiba, Japan
• Kyushu University Hospital — Fukuoka, Japan
• Southern Tohoku Medical Clinic — Fukushima, Japan
• Kobe University Hospital — Hyōgo, Japan
• Kitasato University Hospital — Kanagawa, Japan
• Tohoku University Hospital — Miyagi, Japan
• The University of Osaka Hospital — Osaka, Japan
• The Jikei University Hospital — Tokyo, Japan
• Instituto do Cerebro do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil

Full record on ClinicalTrials.gov

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