NCT04963270

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Satralizumab	Satralizumab will be administered as a subcutaneous injection
OTHER	Placebo	Satralizumab placebo will be administered as a subcutaneous injection

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-01-29
• Completion: 2024-09-02
• First posted: 2021-07-15
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

76 sites across 17 countries: United States, Argentina, Australia, Brazil, Canada, China, Denmark, France, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study