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)

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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)

Brief description of study

The purpose of this study is to compare the effects, good or bad, of satralizumab with placebo alone or in combination with current treatment (baseline/background therapy) on patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). This study will also collect more data on the long-term safety and efficacy of satralizumab and continue providing you with satralizumab treatment during an open-label extension period. Satralizumab is an experimental drug, which means the United States Food and Drug Administration (FDA) has not approved satralizumab as monotherapy (on its own) or in combination with background therapy for the treatment of MOGAD.

Clinical Study Identifier: s21-01090

Principal Investigator: Ilya Kister.

Other Investigators: Mirza Omari, Tyler Ellis Smith, Vito Pasquale Arena.

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