NCT06441812招募中2 期
A Multicenter, Single-group Phase II Clinical Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of Multiple Subcutaneous Injections of SHR-1703 in Eosinophilic Asthma Patients
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年7月19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
- 200
- 试验地点
- 1
- 主要终点
- Adverse Events in main peroid，about 1 year
研究概览
简要总结
The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
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
- •At least 18 years of age, Male or Femal.
- •A minimum weight of 40kg.
- •Subjects with the clinical features of asthma that meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)" and has a medical history of at least 1 year.
- •Documentation of current asthma controller medication [medium or high dose ICS and at least one of additional controller such as long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA) and leukotriene receptor antagonist (LTRA)] for at least 1 stable month before first administration of SHR-
- •At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high daily dose ICS.
- •Absolute count of eosinophils must be ≥0.15×109/L at visit 0 and visit
- •A pre-bronchodilator FEV1 <85% and ≥30% predicted at visit 0 and visit
- •Female subjects with fertility agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures from signing the informed consent form to 14 months after the last dose of SHR-1703, and male subjects with fertility as partners agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures between the first dose of SHR-1703 and the last visit in the study.
- •Subjects must be able to give written informed consent prior to participation in the study.
排除标准
- •Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis or a history of lung cancer.
- •A known immunodeficiency.
- •Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial infarction, unstable angina, heart failure, stroke, and subarachnoid haemorrhage.
- •Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical significance and/or requiring clinical intervention, including but not limited to respiratory infections.
- •A known parasitic infection within the first 6 months before visit
- •A malignancy history within the first 5 years before visit 0 (Subjects that had localized basal carcinoma of the skin or cervical carcinoma in situ which was resected for cure will not be excluded).
- •Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins.
- •Use systemic immunosuppressants (excluding systemic glucocorticoids used for asthma treatment and for non asthma treatment for less than 3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, including but not limited to methotrexate, cyclosporine, interferon-α, anti IL-5 monoclonal antibodies (including SHR-1703), anti IL-4R monoclonal antibodies, anti TSLP monoclonal antibodies, anti IgE monoclonal antibodies, metformin, etc., and within 5 half-lives of the drug before the first administration (refer to the longer drug instructions; for those with unknown half-lives, 12 weeks before the first administration shall prevail);
- •Subjects who have previously participated in any study and received Investigational Product within the first 30 days before visit
- •There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period.
- •Laboratory examination shows obvious abnormalities at visit 0 and visit 1:
- •White blood cell count (WBC) <3.0×109/L;
- •Hemoglobin≤90g/L；
- •Platelet<100×109/L；
- •Alanine aminotransferase (ALT)>2×ULN (upper limit of normal);
- •Aspartate aminotransferase (AST) >2×ULN；
- •Total bilirubin (TBIL)>1.5×ULN;
- •Prothrombin time (PT) >ULN+3s；
- •Creatinin>1.5×ULN;
- •Active hepatitis B (positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood), or positive for hepatitis C virus antibody, or positive for human immunodeficiency virus (HIV) antibody, or positive for treponema pallidum antibody；
- •ECG QTc>450ms or other clinically significant abnormal results that may pose significant safety risks to the subjects at visit 0 or visit 1；
- •A history of drug addicts or substance abuse within 1 years prior to Visit 0；
- •Subjects who are pregnant (positive HCG test at visit 0 or visit 1) or breastfeeding should not be enrolled if they plan to become pregnant during the time of study participation；
- •Subjects with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic；
- •Other reasons determined by the researcher as unsuitable for participation in the study.
研究组 & 干预措施
SHR-1703 Injection
Experimental
干预措施: SHR-1703 Injection (Drug)
结局指标
主要结局
Adverse Events in main peroid，about 1 year
时间窗: about 1 year
次要结局
- Absolute count of eosinophils , about 1 year(about 1 year)
- Frequency and time of asthma exacerbation , about 2 years(about 2 years)
- Reduction in asthma controller , about 1 year(about 1 year)
- Asthma remission, about 2 years(about 2 years)
- Change of FEV1 、FEV1%pred、FVC、PEF，about 1 year.(about 1 year.)
- Questionnaire about asthma，about 1 year .(about 1 year .)
- Change of Fractional Exhaled Nitric Oxide (FeNO) ，about 1 year.(about 1 year.)
- Daily OCS use and reduction, about 1 year.(about 1 year.)
研究者
研究点 (1)
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