Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
A Study On:
Brain - Neurologic/ Psychologic
Study Description
The main objective of the 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
Eligibility
Inclusion criteria
Participants who are aged greater than or equal to 12 years at the time of signing Informed Consent Form
Confirmed diagnosis of MOGAD with a history of greater than or equal to 1 MOGAD relapse in the 12 months prior to screening or greater than or equal to 2 attacks in the 24 months prior to screening
Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
Best corrected 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
Exclusion criteria
Presence of aquaporin-4-antibodies (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 OCS or intravenous (IV) corticosteroids at doses >20 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 three 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
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University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
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