NCT05737160

Study of Telitacicept in Generalized Myasthenia Gravis

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.

Detailed description

This study consists of a screening period, a double-blind treatment period (part A) and an open-label treatment period (part B). After screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous Telitacicept 240 mg or placebo once a week for 24 doses (part A). Completing part A, subjects will automatically enter part B. In part B, all subjects will receive weekly subcutaneous Telitacicept 240 mg for 24 weeks.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
BIOLOGICAL	Telitacicept	Administered as an SC infusion
DRUG	Placebo	Administered as an SC infusion

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-11-26
• Completion: 2024-12-12
• First posted: 2023-02-21
• Last updated: 2025-05-23

Locations

51 sites across 1 country: China