About this trial
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
HR-1703
DrugHR-1703 will be administered by SC injection.
Placebo
DrugMatching Placebo will be administered by the SC injection.
Treatment groups
Trial outcomes
Primary outcomes
Annualised asthma exacerbation rate,about 48weeks
Secondary outcomes
Mean number of days with oral corticosteroids taken for exacerbation,about 48weeks
Frequency of exacerbations requiring hospitalisation,about 48weeks
Time to first exacerbation requiring hospitalisation,about 48weeks
Mean change from baseline in clinic pre- and post-BD FEV1,about 64 weeks
Sponsors and contacts
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