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

Summary

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.

Timeline

Start

2022-08-30

Primary completion

2025-11-20

Completion

2028-05-20

Outcome

Met primary endpoint

release “Phase III METEOROID study met its primary endpoint in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)” gene.com ↗

Drugs

Indications