Actively Recruiting

Phase 3
Age: 12Years - 80Years
All Genders
NCT07249632

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

Led by RemeGen Co., Ltd. · Updated on 2026-04-09

120

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

Sponsors

R

RemeGen Co., Ltd.

Lead Sponsor

H

Huashan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 12Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily signed the informed consent form.
  • Age 12 to 80 years, inclusive, male or female.
  • Body weight 30 kg or more.
  • Diagnosis of Myasthenia Gravis with clinical features consistent with the disease.
  • Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Type I.
  • On stable standard-of-care treatment regimen.
Not Eligible

You will not qualify if you...

  • Having autoimmune diseases that require systemic corticosteroid therapy.
  • Clinically significant laboratory abnormalities.
  • Use of other immunosuppressants outside stable standard-of-care within 1 month before randomization.
  • Having an acute or chronic infection requiring treatment.
  • Current active hepatitis or history of severe liver disease.
  • Positive for HIV antibodies.
  • Positive for syphilis antibodies.
  • Poorly controlled diabetes mellitus (HbA1c >9.0% or fasting blood glucose ≥11.1 mmol/L).
  • Presence of thymoma (≤ Stage II benign or ≥ Stage III malignant).
  • Uncontrolled chronic degenerative, psychiatric, or neurological diseases other than MG that could affect assessments.
  • Other diseases causing ptosis, peripheral muscle weakness, or double vision.
  • Known allergy to human-derived biological products.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing Hospital

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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