A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)

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.

NCT Number	NCT07249632
Lead Sponsor	RemeGen Co., Ltd. Collaborators: Huashan Hospital, Beijing Hospital
Conditions	Myasthenia Gravis, Ocular
Enrollment	120 participants
Start Date	2026-01-13
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-04-09