A Long-term Open-label Extension Study to Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Incidence of AEs during the study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the HBM9161.3 Phase 3 study
- •Signed written informed consent.
- •Suitable for continued treatment with HBM9161 as judged by the investigator.
- •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.
- •A negative urine pregnancy at baseline must be observed for women of childbearing age.
排除标准
- •Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study.
- •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.
研究组 & 干预措施
HBM9161 Drug Product (680mg)
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.
干预措施: HBM9161 Injection (680mg) (Drug)
结局指标
主要结局
Incidence of AEs during the study
时间窗: during the study，up to 24 weeks
Incidence of AEs
次要结局
- 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))
- 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)
- Improvement of patients' quality of life(during the study，up to 24 weeks)
- Proportion of time remained in Minimal Symptom Expression(during the study，up to 24 weeks)
- Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies(during the study，up to 24 weeks)