The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
SHR-1703 will be administered by SC injection.
Matching Placebo will be administered by the SC route.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Changes from baseline in Blood Eosinophils
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FEV1
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FVC
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator PEF
Time frame: Up to Week 52
Changes from baseline in n fractional exhaled nitric oxide (FeNO)
Time frame: Up to Week 52
Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)
Time frame: Up to Week 52
Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Up to Week 52
Frequency of use of asthma relievers
Time frame: Up to Week 24
Frequency of exacerbations of asthma
Time frame: Up to Week 24
Frequency of severe exacerbations of asthma
Time frame: Up to Week 24
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Time to first exacerbation of asthma
Time frame: Up to Week 24
Time to first severe exacerbation of asthma
Time frame: Up to Week 24