Telitacicept for ocular myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study enrolling about 120 participants who will be randomized 1:1 to telitacicept or matching placebo with dosing based on age and body weight. Randomization is stratified by acetylcholine receptor antibody status and by age (<18 vs ≥18). The primary endpoint is change from baseline in the patient-reported MGII ocular score at Week 24, with additional ocular and total MG outcome measures and safety assessments as secondary endpoints. Safety will be monitored through adverse event reporting, labs, vital signs, physical exams, and oversight by an independent Data Monitoring Committee.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Concomitant autoimmune diseases requiring systemic corticosteroid therapy.
2. Clinically significant laboratory abnormalities.
3. Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.
4. Presence of an acute or chronic infection requiring treatment.
5. Current active hepatitis or history of severe liver disease.
6. Positive for HIV antibodies.
7. Positive for syphilis antibodies (non-specific or specific).
8. Poorly controlled diabetes mellitus, defined as HbA1c \>9.0% or fasting blood glucose ≥11.1 mmol/L.
9. Subjects with thymoma (classified as ≤ Stage II for benign and ≥ Stage III for malignant according to the Masaoka staging system) .
10. Presence of uncontrolled chronic degenerative diseases, psychiatric disorders, or neurological diseases other than MG that could interfere with study assessments.
11. 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.).
12. Known allergy to human-derived biological products.

Where it's running

• Beijing Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.