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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBM9161 Drug Product (680mg) | Experimental | HBM9161 680mg: subcutaneous injection, 6 times per treatment cycle, once a week; the second cycle of treatment may start 4 weeks after the last dose of the previous treatment cycle; if the disease state is still stable 4 weeks after the last dose, the observation can be continued until the disease activity is aggravated (improvement of MG-ADL < 3 points compared with the previous treatment cycle), and the next treatment cycle can start. The dose may be reduced to 340 per investigator's discretion. Return to the dose of 680 mg is not permitted after a dose reduction is made. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBM9161 Injection (680mg) | Drug | HBM9161 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs during the study | Incidence of AEs | during the study,up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sustained improvement | 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 each treatment cycle (5-week treatment period + 4-week observation period, from the first dose of the cycle to Day 64 of the cycle) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000722910 | HBM9161 |
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| 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 | from baseline to Week 24, percentage of time MG-ADL score being 0 or 1 | during the study,up to 24 weeks |
| Improvement of patients' quality of life | Improvement of patients' quality of life | during the study,up to 24 weeks |
| Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies | Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies | during the study,up to 24 weeks |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |