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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | dose 1 |
|
| Cohort B | Experimental | dose 2 |
|
| Cohort C | Experimental | dose 3 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905 | Drug | subcutaneous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Annual asthma exacerbation rate (AAER) | From randomisation to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of fractional exhaled nitric oxide (FeNO) compared with baseline | Baseline to72 weeks | |
| Changes from baseline in Asthma Control questionnaire (ACQ-6) scores | Baseline to 72 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510163 | 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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SHR-1905 compared with placebo
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| placebo |
| Drug |
subcutaneous ,placebo |
|
| Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores |
| Baseline to 72 weeks |
| AAER associated with hospitalization at 48 weeks | From randomisation to 48 weeks |
| Changes from baseline in Asthma Symptom Diary scores | Baseline to 72 weeks |
| The proportion of subjects with acute exacerbations of asthma | Baseline to 72 weeks |
| Changes from baseline in weekly reliever use | Baseline to 72 weeks |
| Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF) | Baseline to 72 weeks |
| Changes from baseline in weekly mean number of night time awakenings | Baseline to 72 weeks |
| Time to the first acute asthma exacerbation | Baseline to 72 weeks |
| The proportion of subjects with composite endpoint for asthma (CompEx) | Baseline to72 weeks |
| Pharmacokinetics (PK): Serum concentration of SHR-1905 | 72 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |