NCT05593250进行中（未招募）2 期
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Efficacy：Annual asthma exacerbation rate (AAER)
研究概览
简要总结
This study is a phase 2 study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.
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
- •Male or female aged between 18 and 75 years (inclusive)
- •Weight ≥ 40 kg
- •Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
- •Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
- •At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
- •At least 2 exacerbations within 12 months before screening
- •No birth plan and must agree to take effective contraceptive methods
- •Sign informed consent form voluntarily for the trial
排除标准
- •Any clinically important pulmonary disease
- •Any disease other than asthma that may affect lung function
- •Any disease other than asthma related to elevation of eosinophils
- •Any immunodeficiency disease
- •Any clinically important serious cardiovascular diseases unstable or uncontrolled
- •Uncontrolled Hypertension
- •Uncontrolled Diabetes Mellitus
- •Any clinically important infections within 4 weeks before randomization
- •Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator
- •Any parasitic infections within 6 months before randomization
- •Malignancy diagnosed within 5 years before randomization
- •Abnormal laboratory tests during screening and baseline
- •Positive infectious disease test
- •Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
- •Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
- •Drug or alcohol abuse
- •Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
- •Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
- •Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
- •Any other circumstance inappropriate for participating in the clinical trial considered by the investigator
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Cohort C
Experimental
dose 3
干预措施: SHR-1905 (Drug)
Cohort A
Experimental
dose 1
干预措施: SHR-1905 (Drug)
Cohort B
Experimental
dose 2
干预措施: SHR-1905 (Drug)
结局指标
主要结局
Efficacy：Annual asthma exacerbation rate (AAER)
时间窗: From randomisation to 48 weeks
次要结局
- Changes from baseline in Asthma Symptom Diary scores(Baseline to 72 weeks)
- Changes from baseline in weekly reliever use(Baseline to 72 weeks)
- The proportion of subjects with composite endpoint for asthma (CompEx)(Baseline to72 weeks)
- Changes of fractional exhaled nitric oxide (FeNO) compared with baseline(Baseline to72 weeks)
- Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores(Baseline to 72 weeks)
- AAER associated with hospitalization at 48 weeks(From randomisation to 48 weeks)
- The proportion of subjects with acute exacerbations of asthma(Baseline to 72 weeks)
- Changes from baseline in weekly mean number of night time awakenings(Baseline to 72 weeks)
- Changes from baseline in Asthma Control questionnaire (ACQ-6) scores(Baseline to 72 weeks)
- Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)(Baseline to 72 weeks)
- Time to the first acute asthma exacerbation(Baseline to 72 weeks)
- Pharmacokinetics (PK): Serum concentration of SHR-1905(72 weeks)
研究者
研究点 (1)
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