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

NCT07249632 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Myasthenia Gravis, Ocular

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.

Sponsors & Collaborators

  • Huashan Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249632 on ClinicalTrials.gov