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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Efficacy:Annual asthma exacerbation rate (AAER)
Time frame: From randomisation to 48 weeks
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline
Time frame: Baseline to72 weeks
Changes from baseline in Asthma Control questionnaire (ACQ-6) scores
Time frame: Baseline to 72 weeks
Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores
Time frame: Baseline to 72 weeks
AAER associated with hospitalization at 48 weeks
Time frame: From randomisation to 48 weeks
Changes from baseline in Asthma Symptom Diary scores
Time frame: Baseline to 72 weeks
The proportion of subjects with acute exacerbations of asthma
Time frame: Baseline to 72 weeks
Changes from baseline in weekly reliever use
Time frame: Baseline to 72 weeks
Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Time frame: Baseline to 72 weeks
Changes from baseline in weekly mean number of night time awakenings
Time frame: Baseline to 72 weeks
Time to the first acute asthma exacerbation
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Time frame: Baseline to 72 weeks
The proportion of subjects with composite endpoint for asthma (CompEx)
Time frame: Baseline to72 weeks
Pharmacokinetics (PK): Serum concentration of SHR-1905
Time frame: 72 weeks