NCT04302103已完成2 期
A Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Systemic Myasthenia Gravis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 24
- 主要终点
- The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline
研究概览
简要总结
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic 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
- None
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
- •Voluntarily signed informed consent ;
- •Patient diagnosed with systemic myasthenia gravis according to The following conditions.
- •Seropositive at screening for AChR（Acetylcholine receptor）-Ab or MuSK（Muscle specific tyrosine kinase）-Ab;
- •MGFA（Myasthenia Gravis Foundation of America） Clinical classification Ⅱ-IIIb;
- •QMG score≥8,and QMG score>2 in four or more items;
- •Maintained any one of the stable standard treatment programs in the trial protocol.
排除标准
- •Combined autoimmune diseases, such as systemic lupus erythematosus,rheumatoid arthritis, systemic sclerosis and so on,except for hypothyroidism and hyperthyroidism;
- •Abnormal laboratory parameters need to be excluded, including but not limited to:
- •Immunosuppressive agents except agents of standard treatment programs were used within one month prior to randomization.;
- •Use of biological agents for targeted therapy within 6 months prior to randomization;
- •Intravenous immunoglobulin therapy or plasma exchange therapy within 2 months before randomization;
- •Active infection during screening(For example,herpes zoster,HIV antibody positive,active tuberculosis,etc);
- •Currently suffering from active hepatitis or severe liver lesions and history;
- •Diabetics with poor blood sugar control:HbAlc>9.0% or FBG≥11.1mmol/L;
- •Currently having a thymic tumor ,or had a thymectomy within 6 months prior to screening;
- •Received live vaccines within 3 months before randomization,or scheduled to administer vaccine during the trial;
- •Malignant tumor patients;
- •Allergic to human biological preparations;
- •Have participated in any clinical trial within 28 days before randomization,or in 5 times half-life period of the drugs of any clinical trial(taking the longer time).
- •Pregnant , lactating women and men or women who have birth plans during the research;
- •Having alcohol or drug abuse that affect the experimental conditions;
- •Investigator considers candidates not appropriating for the study.
研究组 & 干预措施
RC18 160mg
Experimental
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
干预措施: RC18 160mg (Biological)
RC18 240 mg
Experimental
Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
干预措施: RC18 240 mg (Biological)
结局指标
主要结局
The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline
时间窗: week 24
QMG score=Quantitative Myasthenia Gravis Score
次要结局
- The average variation of clinical absolute score for myasthenia gravis of the twelfth and twenty-fourth weeks compared to Clinical absolute score for myasthenia gravis of baseline(week 12，24)
- The average variation of QMG score of the twelfth week compared to the OMG scores of baseline(week 12)
研究者
研究点 (24)
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