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

Summary

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

Timeline

Start

2021-10-19

Primary completion

2024-01-29

Completion

2024-09-02

Outcome

Met primary endpoint

Stopped: “Sponsor decided to halt development of satralizumab in generalized myasthenia gravis and discontinued further dosing with the study drug (while the OLE period was ongoing) upon reviewing the primary results (DB period).”

registry analysis (superiority test); Placebo vs Satralizumab; p = 0.0196; Difference in Adjusted Mean -1.02 (95% CI -1.88 to -0.16) NCT04963270 ↗

paper At week 24, statistically significant yet small improvements in MG-ADL score were observed with satralizumab versus placebo PMID 39862880 ↗

release “Statistically significant data was observed in the primary endpoint of the phase III LUMINESCE study” chugai-pharm.co.jp ↗

Publications

• Habib AA, Zhao C, Aban I, Franca MC Jr, Jose JG, Zu Horste GM, Klimiec-Moskal E, Pulley MT, Tavolini D, Krumova P, Lennon-Chrimes S, Smith J, Thanei GA, Blondeau K, Vodopivec I, Wolfe GI, Murai H. Safety and efficacy of satralizumab in patients with generalised myasthenia gravis (LUMINESCE): a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2025 Feb;24(2):117-127. doi: 10.1016/S1474-4422(24)00514-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Satralizumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Satralizumab	Monoclonal antibody	180 mg	Subcutaneous

Indications