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A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
Sponsor: RemeGen Co., Ltd.
Summary
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible subjects aged 12 to 80 years with a diagnosis of OMG (Myasthenia Gravis Foundation of America \[MGFA\] Clinical Classification Type I) will be randomized in a 1:1 ratio to receive either Telitacicept or a matching placebo. Subjects must be on a stable standard-of-care therapy and have an MG Impairment Index (PRO) ocular score of ≥6 at screening and baseline.The dose is age and weight based.The primary objective is to evaluate the efficacy of Telitacicept compared to placebo in treating OMG.The primary efficacy endpoint is the change from baseline in the MGII (PRO) ocular score at Week 24. Secondary endpoints include changes from baseline in other ocular and total scores from MGII, Myasthenia Gravis-Activities of Daily Living (MG-ADL), MG Clinical Absolute Score, and the 15-item Myasthenia Gravis Quality of Life Revised scale (MG-QOL15r). Safety and tolerability will be monitored throughout the study.
Official title: A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis
Key Details
Gender
All
Age Range
12 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-01-13
Completion Date
2027-02-28
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Telitacicept
The dosage is administered based on the subject's age and baseline body weight.
Placebo
The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
Locations (1)
Beijing Hospital
Beijing, Beijing Municipality, China