Myasthenia Gravis
Conditions
Interventions
Group 1:HBM9161
Group 2:Placebo
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years at the screening visit, no gender limit. 2. Meet the MGFA clinical classification of myasthenia gravis IIa-IVa at the screening visit and baseline visit. 3. Female subjects must meet the following conditions to participate in this study: (1) Infertility potential (i.e., biologically incapable of becoming pregnant, including women who have been menopausal for 2 years or more); (2) Potentially fertile, with a negative serum pregnancy test result at the screening visit, and agree to adhere to the proper use of one of the following acceptable and effective contraceptive methods (i.e., in accordance with the approved product label insert and physician's instructions) during the study period from the screening visit until 14 days after the final visit: 1) Complete abstinence (based on subjects preferences and previous lifestyle); 2) The levonorgestrel implant should be implanted at least 1 month before the administration of the study drug, but the implantation time should not exceed 3 years; 3) Progesterone injection at least 1 month before study drug administration; 4) Oral contraceptives (combined contraceptives or progestin only) for at least 1 month cycle before study drug administration; 5) Double contraceptive measures: condom or cervical cap (diaphragm or cervical cap) plus spermicide (foam/gel/cream/suppository); 6) IUD, implanted by a qualified doctor; 7) Estrogen vaginal ring; 8) Transdermal contraceptive patches. 4. Compliance: Subjects must be willing to complete all visit assessments at the study site as required by the trial protocol. 5. Receive at least one stable treatment for myasthenia gravis at random visit. 6. According to the judgment of the investigator, the subject is willing and able to adjust the current disease treatment according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Suffering from a serious disease or condition other than myasthenia gravis, that is, a disease that, in the judgment of the investigator, would put the subject at risk by participating in the study, or have an impact on the results of the study and the subject's ability to participate in this study . 2. The last immunosuppressive monoclonal antibody treatment was less than 6 months from the screening visit, or more than 6 months after the end of use, but the B cell count did not return to the lower limit of normal. 3. There are other autoimmune diseases (such as uncontrolled thyroid disease, severe rheumatoid arthritis, etc.) that may affect the efficacy evaluation of the study drug or affect the participation in this study. 4. Subjects who are allergic to the test drug or its components; or the investigator believes that there is a clinically significant history of allergic disease (including drug allergy, allergic reaction) that affects the subject's participation in this study. 5. Subjects treated with study drug in another clinical trial during the last 30 days or 5 half-lives or the drug's effect time (whichever is longest) prior to the screening visit (Note: Subjects who participated in observational studies, i.e. studies that did not require changes in medication or other interventions, were not excluded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myasthenia Gravis Activities of Daily Living (MG-ADL) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative Myasthenia Gravis (QMG) Score; | — |
Countries
China
Contacts
Public ContactSu Yan
Outcome results
None listed