Study of Telitacicept in Generalized Myasthenia Gravis
Study of Telitacicept in Generalized Myasthenia Gravis
ClinicalTrials.gov 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.
OFFICIAL TITLE:
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
INTERVENTION / TREATMENT:
- 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 |