Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving SHR-1703 dose 1 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR-1703 | Drug | HR-1703 will be administered by SC injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Annualised asthma exacerbation rate,about 48weeks | about 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of days with oral corticosteroids taken for exacerbation,about 48weeks | about 48weeks | |
| Frequency of exacerbations requiring hospitalisation,about 48weeks | about 48weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Wang | Contact | +086-18260387118 | xiaopeng.wang@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China School of Medicine West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching Placebo will be administered by the SC injection. |
|
| 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 |