Telitacicept for ocular myasthenia gravis, compared with placebo

Trial details

Who runs it

RemeGen Co., Ltd.

Trial code

NCT07249632

Record updated

9 April 2026

Original description

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.Read full original descriptionShow less

A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis

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.

Inclusion: Voluntarily signed the informed consent form; Age 12 to 80 years, inclusive, male or female; Body weight ≥30 kg; Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease; Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I; On a stable standard-of-care (SOC) treatment regimen.

Exclusion: Concomitant autoimmune diseases requiring systemic corticosteroid therapy; Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization; Positive for syphilis antibodies (non-specific or specific); Presence of an acute or chronic infection requiring treatment; Current active hepatitis or history of severe liver disease; Positive for HIV antibodies; Subjects with thymoma (classified as ≤ Stage II for benign and ≥ Stage III for malignant according to the Masaoka staging system) ; Presence of uncontrolled chronic degenerative diseases, psychiatric disorders, or neurological diseases other than MG that could interfere with study assessments; Other diseases causing ptosis, peripheral muscle weakness, or diplopia (e.g., Graves' ophthalmopathy, blepharospasm, progressive external ophthalmoplegia, muscular dystrophy, brainstem or cranial nerve lesions, etc.); Known allergy to human-derived biological products; Clinically significant laboratory abnormalities; Poorly controlled diabetes mellitus, defined as HbA1c >9.0% or fasting blood glucose ≥11.1 mmol/L.

ClinicalTrials.gov NCT07249632