Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD)
Conditions
Sponsors
Ivana Vodopivec
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who are capable of giving signed informed consent and are aged >=12 years at the time of signing Informed Consent Form 2. 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 3. Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening 4. High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening 5. Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening 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
Exclusion criteria: 1. Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum 2. History of encephalitis unrelated to MOGAD 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 4. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab 5. Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline 6. Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) 7. Participants with positive screening tests for hepatitis B and C 8. Receipt of live or live attenuated vaccine within 6 weeks prior to baseline 9. History of severe allergic reaction to a biologic agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy, Exploratory, Phamacokinetics, Other To evaluate the efficacy of satralizumab compared with placebo - Annualized rate of adjudicated MOGAD relapses - Annualized rate of active lesions on MRI of the neuroaxis - Proportion of participants receiving rescue therapy - Annualized rate of inpatient hospitalizations To evaluate the safety of satralizumab compared with placebo | — |
Countries
Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Republic of Korea, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed