Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT05737160
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2023-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Telitacicept in Generalized Myasthenia Gravis
Sponsor:
RemeGen Co., Ltd.
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: