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This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK139 regimen 1 | Experimental |
| |
| AK139 regimen 2 | Experimental |
| |
| AK139 regimen 3 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK139 | Drug | AK139 regimen 1- subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in pre-bronchodilator FEV1 | Up to week 12 | |
| Absolute change and percent change from baseline in FENO | Up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), serious adverse events(SAEs) | Up to week 4 | |
| Serum AK139 concentration | Up to week 20 | |
| Immunogenicity characteristics of AK139 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoqin Wang | Contact | +86 (0760) 8987 399 | global.trials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China | ||||
| Shanghai General Hospital |
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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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| AK139 |
| Drug |
AK139 regimen 2- subcutaneous injection. |
|
| AK139 | Drug | AK139 regimen 3- subcutaneous injection. |
|
| Placebo | Drug | subcutaneous injection. |
|
Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. |
| Up to week 20 |
| Shanghai |
| China |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |