NCT05271409

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Interventions

Type	Name	Description
DRUG	Satralizumab	Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
OTHER	Placebo	Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.

Timeline

• Start date: 2022-08-30
• Primary completion: 2025-11-20
• Completion: 2028-12-31
• First posted: 2022-03-09
• Last updated: 2026-04-13

Locations

82 sites across 11 countries: United States, Australia, Brazil, Canada, France, Germany, Israel, Italy, Japan, Poland, South Korea

Regulatory

• FDA-regulated drug study