NCT05067348

Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

Detailed description

This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study. All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	Tocilizumab Injectable Product	Participants will receive IV tocilizumab

Timeline

• Start date: 2022-07-21
• Primary completion: 2025-12-31
• Completion: 2026-03-30
• First posted: 2021-10-05
• Last updated: 2025-05-01

Locations

6 sites across 1 country: China