Generalized Myasthenia Gravis
Conditions
Interventions
Interventions group:Ripertamab was administered intravenously at a dose of 375 mg/m^2 of body surface area on Day 1 of the treatment period.
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age at screening: 18 years = 6, with ocular subscore accounting for less than 50% of the total score; (5) Myasthenia Gravis Foundation of America (MGFA) clinical classification of II, III, or IV; (6) Patient and/or their legal guardian voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Any condition that, in the investigator's judgment, may interfere with the evaluation or administration of the study drug, the assessment of patient safety, or the interpretation of the study results. (2) Any uncontrolled active infection or severe infection within 8 weeks prior to the screening period. (3) Treatment with rituximab or any B-cell depleting agent within 6 months prior to screening (subjects with CD19+ or CD20+ B-cell counts above the lower limit of normal may be enrolled). (4) Use of tocilizumab, eculizumab, mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first dose. (5) Use of immunosuppressants other than corticosteroids within 1 month prior to the first dose, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, methotrexate, etc. (6) Use of plasma exchange (PE) or moderate-volume blood transfusion, or immunomodulatory drugs such as interferon-beta, interferon-gamma, or intravenous immunoglobulin (IVIG) within 1 month prior to the first dose. (7) Thymectomy within 12 months prior to baseline or planned thymectomy during the 12-week study. (8) Coexisting chronic active immune system diseases requiring treatment with corticosteroids, biologics, or immunosuppressants (e.g., rheumatoid arthritis, scleroderma, etc.). (9) Administration of any live or live-attenuated vaccine within 1 month prior to the first dose. (10) Previous history of bone marrow transplantation, hematopoietic stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy. (11) Treatment with any investigational drug within 28 days prior to the first dose or within 5 half-lives of the investigational product, whichever is shorter. (12) Known allergy to any component of Ripertamab. (13) Pregnant or lactating women; for women of childbearing potential who have not undergone sterilization: unwilling to use adequate contraception (e.g., oral contraceptives, intrauterine device, or barrier method combined with spermicide) from the start of screening until 6 months after the end of treatment. (14) For men who have not undergone sterilization: unwilling to use barrier contraception from the start of screening until 6 months after the end of treatment, and unwilling to request their partner to use an additional contraceptive method (e.g., oral contraceptives, intrauterine device, barrier method, or spermicide).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myasthenia Gravis-Activities of Daily Living Scale Score changes at week 13; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative Myasthenia Gravis Score changes at week 13;Adverse Events;Myasthenia Gravis-Activities of Daily Living Scale Score changes at week 25;Myasthenia Gravis Composite changes at week 13;15 Revised Quality of Life Scales for Myasthenia Gravis score changes at week 13;minimal symptom expression;steroid dosage change;whether to undertake remedial treatment; | — |
Countries
China
Contacts
Public ContactQingwu Yang
Second Affiliated Hospital of Army Medical University
Outcome results
None listed