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This study is a phase III 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1905 Group | Experimental |
| |
| SHR-1905 Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905 Injection | Drug | SHR-1905 injection. |
| |
| SHR-1905 Placebo Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Annual asthma exacerbation rate | During 48 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) | At Week 48. | |
| Proportion of participants who had asthma exacerbations | From randomization to Week 48. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Li | Contact | +86-020-62726806 | zhou.li.zl69@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510830 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
SHR-1905 placebo Injection. |
|
| Time to the first asthma exacerbation | From randomization to Week 48. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |