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Clinical trial

Study of Telitacicept in Generalized Myasthenia Gravis

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Last updated:20th Feb 2023
Identifier: NCT05737160
Study of Telitacicept in Generalized Myasthenia Gravis ID: NCT05737160

Sponsor: RemeGen Co., Ltd.
Information provided by: RemeGen Co., Ltd. (Responsible Party)
Last Update Posted: 2023-02-21

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.

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

- Biological: Telitacicept
- Drug: Placebo

Category Value
Study Start (Estimated) 2023-05
Primary Completion (Estimated) 2026-12
Study Completion 2027-05
Enrollment (Estimated) 100
Study Type Interventional
Phase Phase 3
Other Study ID Numbers 18C029

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