NCT06447597招募中2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis
Shanghai Jiaolian Drug Research and Development Co., Ltd18 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 18
- 主要终点
- Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent form;
- •Subjects with generalized myasthenia gravis;
- •Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
- •MG-ADL ≥5 at screening and baseline;
- •Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
- •Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.
排除标准
- •Subjects with MGFA I and V type;
- •Subjects usingprescribed drugs;
- •Subjects with a prescribed disease or history of disease;
- •The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
- •Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
- •Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
- •Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
- •Pregnant and lactating women;
- •Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
- •Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
- •A history of alcohol or drug abuse within the past 12 months;
- •Other conditions deemed unsuitable for participation in this study by the researchers.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
B007
Experimental
干预措施: B007 (Drug)
结局指标
主要结局
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
时间窗: Approximately 16 weeks
Proportion of subjects：MG-ADL decreased by ≥2
次要结局
- Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2(Approximately 24 weeks)
- Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3(Approximately 24 weeks)
- Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.(Approximately 24 weeks)
- Changes in MGC (Myasthenia gravis composite) from baseline.(Approximately 24 weeks)
- Incidence of Treatment-Emergent Adverse Events(Approximately 1 years)
研究者
研究点 (18)
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