Myasthenia Gravis
Conditions
Brief summary
The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.
Interventions
HBM9161 Injection
Sponsors
Harbour BioMed (Guangzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completed the HBM9161.3 Phase 3 study 2. Signed written informed consent. 3. Suitable for continued treatment with HBM9161 as judged by the investigator. 4. Female patients of childbearing potential and male patients with female partners of childbearing potential can participate in this study, but reliable contraceptive measures must be taken (such as physical barrier contraception (patients and their partners), contraceptive pills or patches, spermicide and barrier or intrauterine device). Up to 60 days after the last dose. 5. A negative urine pregnancy at baseline must be observed for women of childbearing age.
Exclusion criteria
1. Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study. 2. Females who are pregnant or lactating or planning to become pregnant during the study period, or females of childbearing potential who are not using an effective method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs during the study | during the study，up to 24 weeks | Incidence of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with sustained improvement | during each treatment cycle (5-week treatment period + 4-week observation period, from the first dose of the cycle to Day 64 of the cycle) | Sustained reduction defined as MG-ADL score improved by ≥ 3 points from baseline for at least 4 consecutive weeks during the 9-week treatment cycle |
| During the 24-week study, proportion of time that MG-ADL improved from baseline by 3 or more points | during the study，up to 24 weeks | — |
| Proportion of time remained in Minimal Symptom Expression | during the study，up to 24 weeks | from baseline to Week 24, percentage of time MG-ADL score being 0 or 1 |
| Improvement of patients' quality of life | during the study，up to 24 weeks | Improvement of patients' quality of life |
| Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies | during the study，up to 24 weeks | Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies |
Countries
China
Outcome results
None listed