IRB Study Number 22-1169
Status Recruiting
Phase Phase 3
Location U Building - Mellen Center
Institute Neurological Institute
Description
The purpose of this study is to compare the effects, safety, and efficacy of an experimental drug, satralizumab, with placebo alone or in combination with current treatment on patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Satralizumab works by binding to receptor sites of interleukin-6 (IL-6), a cytokine that plays a key role in MOGAD and other inflammatory processes. When bound to these sites, signal transmission to inflammation is prevented.
There are multiple research visits that must be attended, and participation may last up to 5 years. Study activities include questionnaires/assessments, MRIs and electrocardiograms, blood sample collection, and receiving the study drug/placebo.
Compensation provided.
Inclusion Criteria
- Age 12+ years
- Confirmed diagnosis of MOGAD with at least 1 relapse in last 12 months or at least 2 attacks in last 24 months
- Expanded Disability Status Scale (EDSS) score of 0-6.5
Exclusion Criteria
- Presence of aquaporin-4-antibodies (AQP4-IgG)
- History of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis
- Any active or recurrent bacterial, viral, fungal, mycobacterial infection (or other infection)
- Concomitant disease requiring treatment with immunosuppresion or steroids at doses <20 mg prednisone equivalent per day for >21 days during study
