NCT05716035

Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).

Detailed description

tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG. After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG. Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	Tocilizumab Injection	Participants will receive IV tocilizumab

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2023-02-08
• Last updated: 2024-01-22

Locations

6 sites across 1 country: China