NCT05522439已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Pharmacodynamic, Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1703 in Asthma Patients With Eosinophil Phenotype
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Changes from baseline in Blood Eosinophils
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75years (inclusive).
- •Weight ≥40 kg.
- •History of asthma≥ 1 year.
- •Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.
- •Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.
- •Blood eosinophils of ≥150 cells/µL at screening and baseline.
- •Pre-Bronchodilator FEV1% pred≥40% and<80% at screening and baseline.
- •Asthma Control Questionnaire-6 score≥1.
- •Use highly effective contraceptive measures.
- •Willing to sign the informed consent form to participate in this study.
排除标准
- •Subjects with Clinically significant pulmonary diseases；
- •Subjects with other diseases that could lead to elevated eosinophils；
- •Subjects with Immunodeficiency；
- •Poorly controlled hypertension;
- •Subjects with severe cerebrovascular disease;
- •Subjects with infection history requiring clinical intervention；
- •Subjects with parasitic infection；
- •Diagnosed Malignant tumor within 5 years prior to randomization;
- •Used non-selective β-blockers within 1 week prior to randomization;
- •Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization;
- •Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization;
- •Live attenuated vaccine inoculated within 4 weeks before randomization;
- •Allergen Immunotherapy within 8 weeks prior to randomization；
- •Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;
- •Bronchial thermoplasty within 1 year prior to randomization；
- •Subjects have planned Surgery or other medical procedures that may affect evaluation during the study period;
- •Subjects with significant laboratory abnormality at screening；
- •Subjects have prolonged QTc interval or other electrocardiogram abnormality with significant safety risk at screening;
- •Current smokers or ex-smokers who have given up smoking for <6 months ，or positive smoke test, and/or have a smoking pack history of > 10 pack years;
- •History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
- •Subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening;
- •Subjects is pregnant, lactating,or planning to become pregnant;
- •Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;
- •Other conditions unsuitable for participation in the study per investigator judgement.
研究组 & 干预措施
Subjects receiving SHR-1703 dose 1
Experimental
干预措施: SHR-1703 (Drug)
Subjects receiving SHR-1703 dose 1
Experimental
干预措施: SHR-1703 Placebo (Drug)
Subjects receiving SHR-1703 dose 2
Experimental
干预措施: SHR-1703 (Drug)
Subjects receiving SHR-1703 dose 3
Experimental
干预措施: SHR-1703 (Drug)
Subjects receiving SHR-1703 dose 3
Experimental
干预措施: SHR-1703 Placebo (Drug)
Placebo
Placebo Comparator
干预措施: SHR-1703 Placebo (Drug)
结局指标
主要结局
Changes from baseline in Blood Eosinophils
时间窗: Up to Week 52
次要结局
- Changes from baseline in Pre- and post-Bronchodilator FVC(Up to Week 52)
- Changes from baseline in Pre- and post-Bronchodilator PEF(Up to Week 52)
- Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred(Up to Week 52)
- Changes from baseline in Pre- and post-Bronchodilator FEV1(Up to Week 52)
- Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)(Up to Week 52)
- Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)(Up to Week 52)
- Frequency of use of asthma relievers(Up to Week 24)
- Changes from baseline in n fractional exhaled nitric oxide (FeNO)(Up to Week 52)
- Time to first exacerbation of asthma(Up to Week 24)
- Frequency of exacerbations of asthma(Up to Week 24)
- Frequency of severe exacerbations of asthma(Up to Week 24)
- Time to first severe exacerbation of asthma(Up to Week 24)
研究者
研究点 (1)
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