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RECRUITING
NCT07249632
PHASE3

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

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Telitacicept

The dosage is administered based on the subject's age and baseline body weight.

DRUG

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