drugset / Trial / NCT05271409

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

NCT05271409

Phase 3 Active not recruiting 152 enrolled Hoffmann-La Roche Chugai Pharmaceutical · collab
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Satralizumab Monoclonal antibody Subcutaneous