Myasthenia gravis
Conditions
Interventions
Group 1 :HBM9161 680 mg was administered once a week (QW)
Group 2:HBM9161 340mg was administered 6 times per cycle for two cycles
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who have completed the HBM9161.33 phase study; 2. Sign the written informed consent; 3. The investigator judges that it is suitable to continue to receive the study drug treatment; 4. MG-ADL total score >= 5 points or a reduction of <= 3 points relative to the baseline MG-ADL score of the Phase 9161.33 study; 5. Since the last administration of the study drug in Phase 9161.33, the patient has been treated with a non-hormonal immunosuppressant or cholinesterase inhibitor (defined in "Concomitant Medication and therapy") at a stable dose and route of administration. Oral corticosteroids (<= 40 mg/day of prednisone or its equivalent) are permitted, but the dose must be kept stable. Stable treatment is defined as follows: (1) Cholinesterase inhibitors: The random visit dose is stable for more than 4 weeks; and all clinical evaluations need to be suspended for more than 12 hours; (2) Glucocorticoids: started at least 3 months before the random visit, and the dose was stable for at least 1 month at the random visit (the total daily dose of glucocorticoids should not exceed 40 mg of prednisone or equivalent dose); (3) Immunosuppressants: 1) Azathioprine: started at least 12 months before the random visit, and the dose was stable for at least 4 months at the random visit; 2) Other immunosuppressive drugs (such as cyclophosphamide, cyclosporin A, tacrolimus, motecophenolate, methotrexate, etc.) : started at least 6 months before randomization, and the dose was stable for at least 3 months at randomization; 6. Female patients of childbearing age and male patients with female spouses of childbearing age can participate in this study, but they must take reliable contraceptive measures (such as physical barrier contraception (patients and their spouses), contraceptive pills or patches, spermicides and barrier or palace IUD). Until 60 days after the last dose; 7. Women of childbearing age must have negative urine pregnancy test results at baseline.
Exclusion criteria
Exclusion criteria: 1. Since the last administration of the study drug in the 9161.33 phase of the study, he has been treated with any other clinical study drug; 2. Women who are pregnant or breastfeeding or plan to be pregnant during the study period, or women who are fertile but have not used effective contraceptive methods; 3. The patient's myasthenia gravis is serious (such as IVb or V type), and the researcher judges that it is not suitable to participate in this study (for example, it is expected that artificial assisted ventilation may be needed during the study); 4. Subjects who received intravenous gamma globulin or plasma exchange therapy completed the treatment for the last time less than 4 weeks from the screening visit; 5. There are other autoimmune diseases (such as uncontrolled thyroid diseases, severe rheumatoid arthritis, etc.) that may affect the efficacy evaluation of the study drugs or affect the participation in this study; 6. There are other coexisting diseases or conditions that may affect the evaluation of the therapeutic effect of the research drugs on myasthenia gravis; 7. Have received vaccination 4 weeks before the screening visit or plan to receive vaccination (including COVID-19 vaccine) during the study; 8. There is any active infection during the screening visit, or there is serious infection 8 weeks before the screening visit (requiring intravenous anti-infective drug treatment or hospitalization); 9. Past or present human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection; During the screening visit, the subjects were positive for any of the following tests: HCV antibody, HIV antibody type 1 and 2; 10. During the screening interview of issue 9161.33: (1) When the subject is positive for HBV surface antigen, he has received standard antiviral treatment (entecavir is recommended) for at least 2 weeks before the first dose of study drug (confirmed by medical documents), but did not continue to receive antiviral treatment during the promised study period to 6 months after drug withdrawal; (2) When the subject's HBV surface antigen is negative and anti-HBV core antibody is positive, the quantitative detection of HBV-DNA is more than 2000 IU/mL (all the above results can be used by the inspection results of the 9161.33 group visit); 11. Past or current infection of Mycobacterium tuberculosis (positive or uncertain interferon gamma release test within 12 weeks before screening visit); 12. Suffering from acute liver injury (for example, hepatitis) or severe liver cirrhosis (Child-PughC grade) or any of the following (the inspection results of the 9161.33 group visit can be used): (1) According to the laboratory reference range, the upper limit (ULN) of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 times the normal value during the visit was screened; (2) According to the reference range of the laboratory, the total bilirubin at screening visit was > 1.5 times ULN; 13. Abnormal laboratory examination is of clinical significance, and researchers believe that it will cause risks or affect the participants' participation in the study; or any of the following (the following items are allowed to be retested once during the screening period): (1) Screening the total serum IgG <= 6 g/L at the time of interview; (2) Serum albumin < 3.0 g/dL at screening visit; (3) Neutrophils in blood were less than 1.5 x 10^9/L at screening visit; (4) The blood calcium (or corrected calcium)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events during the study; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who maintained clinical improvement;Proportion of patients’ minimal clinical manifestation maintenance time: from baseline to week 24, the proportion of patients’ minimal clinical manifestations in 24 weeks (AChR-Ab positive or MuSK-Ab positive patient population);Improvement of patients' quality of life;Incidence and time course of serum anti-HBM9161 antibody and neutralizing antibody; | — |
Countries
China
Contacts
Public ContactChongbo Zhao
Harbour BioMed (Suzhou) Co., Ltd.
Outcome results
None listed