NCT06653322进行中（未招募）3 期
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2024年11月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Annualised asthma exacerbation rate，about 48weeks
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age
- •A minimum weight of 40kg
- •A medical history of at least 1 year that meets the diagnosis of asthma;
- •Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
- •Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
- •Absolute count of blood eosinophils suggests eosinophilic asthma
- •During the screening period and baseline, pre- BD FEV1% < 80%
- •During the screening period and baseline, ACQ-6 score indicates asthma poor control
- •History of severe asthma exacerbation within the past 12 months prior to screening
- •Good compliance with eDiary completion
- •Take efficient contraceptive measures
- •Voluntarily sign the informed consent form to participate in this study
排除标准
- •With other condition that could lead to elevated eosinophils
- •With Clinically significant pulmonary diseases
- •With existing immunodeficiency disease
- •With other clinically significant diseases that may affect lung function
- •With uncontrolled severe cardiovascular and cerebrovascular diseases
- •With uncontrolled hypertension and/or diabetes
- •With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
- •Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
- •Existing parasitic infections
- •Diagnosed as malignant tumor within the first 5 years of randomization
- •Significant abnormalities in screening period or baseline laboratory tests
- •Screening period or baseline ECG QTc prolongation
- •Prohibited drugs using during the pre randomization period
- •Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
- •Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
- •History of drug use, alcoholism, or substance abuse within the past year prior to screening
- •Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
- •Pregnant or lactating subjects
- •Other reasons why the researcher deemed it unsuitable for conducting this experiment
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Subjects receiving SHR-1703 dose 1
Experimental
干预措施: HR-1703 (Drug)
结局指标
主要结局
Annualised asthma exacerbation rate，about 48weeks
时间窗: about 48weeks
次要结局
- Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks(about 48weeks)
- Frequency of exacerbations requiring hospitalisation，about 48weeks(about 48weeks)
- Time to first exacerbation requiring hospitalisation，about 48weeks(about 48weeks)
- Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks(about 64 weeks)
- Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks(about 64weeks)
- Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks(about 64 weeks)
- Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks(about 64 weeks)
- Mean change from baseline in FeNO，about 64weeks(about 64weeks)
- Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks(about 64 weeks)
- Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks(about 64weeks)
- Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks(at week 12/24/36/48/60，about 64weeks)
- Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks(at week 12/24/36/48/60，about 64weeks)
- Mean change from baseline in awakening at night due to asthma symptoms requiring rescue medication use at week 12/24/36/48/60，about 64weeks(at week 12/24/36/48/60，about 64weeks)
- Mean change from baseline in morning and evening PEF at week 12/24/36/48/60，about 64weeks(at week 12/24/36/48/60，about 64weeks)
- Mean change from baseline in IgE，about 64weeks(about 64weeks)
- Adverse events，about 64weeks(about 64weeks)
研究者
研究点 (1)
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