Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT07249632
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
80 Years
Study:
NCT07249632
Study Brief:
Protocol Section:
NCT07249632