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The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving SHR-1703 dose 1 | Experimental |
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| Subjects receiving SHR-1703 dose 2 | Experimental |
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| Subjects receiving SHR-1703 dose 3 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1703 | Drug | SHR-1703 will be administered by SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Blood Eosinophils | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Pre- and post-Bronchodilator FEV1 | 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 FVC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
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| SHR-1703 Placebo | Drug | Matching Placebo will be administered by the SC route. |
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| Up to Week 52 |
| Changes from baseline in Pre- and post-Bronchodilator PEF | Up to Week 52 |
| Changes from baseline in n fractional exhaled nitric oxide (FeNO) | 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 |
| Frequency of exacerbations of asthma | Up to Week 24 |
| Frequency of severe exacerbations of asthma | Up to Week 24 |
| Time to first exacerbation of asthma | Up to Week 24 |
| Time to first severe exacerbation of asthma | Up to Week 24 |