A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With An Open-Label Extension Period To Evaluate The Efficacy And Safety Of Telitacicept In Patients With Generalized Myasthenia Gravis
Posted Date: Sep 11, 2025
- Investigator: Hani Kushlaf
- Specialties: Neurology, Neuromuscular Disorders
- Type of Study: Drug
This is a randomized, double-blind, placebo-controlled, parallel, multicenter, interventional Phase 3 study with an open-label extension (OLE) period to evaluate the efficacy and safety of telitacicept in patients with gMG. The study will be divided into screening, double-blind treatment period and OLE followed by safety follow-up period. The total duration of the study is up to 84 weeks, including an up to 4-week screening period, a 24-week double-blind treatment period (Week 0 through Week 24), 48-week OLE period (Week 24 through Week 72) and an 8-week safety follow-up period.
Criteria:
Male Or Female Patient Aged =18 Years At Screening. Patients Have Prior Confirmed Diagnosis Of Gmg With Generalized Muscle Weakness.Patients Have Positive Antibodies Against Achr Or Musk At Screening.
Keywords:
Mg, Myasthenia Gravis
For More Information:
Sharon Briley
5135580163
brileysn@ucmail.uc.edu