Myasthenia Gravis
Conditions
Interventions
Treatment Arm 1:HBM9161 dose 1
Treatment Arm 2:HBM9161 dose 2
Treatment Arm 3:Placebo
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent form (ICF); 2. To screen men or women aged >= 18 years at the time of the visit; 3. Female subjects need to meet the following conditions to participate in this study: (1) No potential fertility (i.e. no physical ability to conceive, including women who have been menopausal for 2 years or more); (2) Potential fertility, negative serum pregnancy test results at the screening visit, and agree to use one of the following acceptable and effective contraceptive methods (i.e. according to the approved product label instructions and doctor's instructions) during the study period from the screening visit until 14 days after the final visit: complete abstinence (based on subjects' preferences and previous lifestyle); or The levonorgestrel implant shall be implanted at least one month before the administration of the study drug for a period of not more than three years; or the progesterone shall be injected at least one month before the administration of the study drug; or the oral contraceptive (compound contraceptive or progesterone only) for a period of at least one month before the administration of the study drug; or Double contraceptive measures: condom or cervical cap (diaphragm or cervical cap) to kill sperm concentrate (foam agent / gel / cream / suppository); or intrauterine device, by qualified doctors; or estrogen vaginal ring, or percutaneous contraceptive patch. 4. Male subjects must take effective contraceptive methods or their heterosexual partners during the clinical trial; 5. AChR AB or musk AB were positive during screening visit, and at least one of the following three items was met: (1) Repeated electrical stimulation indicated dystransmission of neuromuscular junction (including history); (2) Tengxilong test or neostigmine test were positive (including medical history); (3) The doctor judged that the Mg symptoms of the patients improved after the treatment of cholinesterase inhibitors. 6. MGFA myasthenia gravis clinical type IIA IVA; 7. Mg basic treatment is stable.
Exclusion criteria
Exclusion criteria: 1. Screening patients less than 6 months from the last immunosuppressive monoclonal antibody treatment at the time of visit, including but not limited to rituximab, belimumab, ekuzumab, etc. If rituximab or belimumab were used for more than 6 months, B cell count was not recovered to the lower limit of normal value; 2. To select the patients who had thymectomy less than 12 months at the time of visit or the researchers judged that thymectomy might be needed during the study period; 3. The patients with total IgG <= 6 g / L were selected; 4. Patients with a significant disease or condition other than myasthenia gravis, that is, according to the judgment of the researchers, will cause the subjects to be at risk due to participation in the study, or have an impact on the results of the study and the subjects' ability to participate in the study; 5. Patients suffering from serious cardiovascular (including serious arrhythmia), liver, kidney, respiratory system, endocrine system or blood system diseases, or other medical or mental diseases that may hinder the subjects from participating in the study or may cause the subjects to be hospitalized during the study; 6. Patients with any active infection at the time of screening visit, or severe infection (requiring intravenous anti infective drugs or hospitalization treatment) 8 weeks before screening visit; 7. Patients with previous or current human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or Mycobacterium tuberculosis infection. At the time of screening visit, the subjects were positive for any of the following tests: HBV surface antigen, HBV core antibody, HCV antibody, HIV antibody type 1 and 2, and Mycobacterium tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Myasthenia Gravis Composite (MGC) score;Change in the Quantitative Myasthenia Gravis (QMG) score;Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score;Proportion of participants with a decrease on the MG-ADL Score by = 2 points;Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS);Change in the MG-ADL score;Change in the MGC score;Change in the QMG score;Change in the MG-QoL15r score;Proportion of participants with persistent improvement on the MGC score;Proportion of participants with persistent improvement on the MG-ADL score; | — |
Countries
China
Contacts
Public ContactYan Su
Harbour BioMed (Suzhou) Co., Ltd
Outcome results
None listed