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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 SAR
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 SAR. Participants will be randomized to receive AK139 regimen or placebo subcutaneous injection and followed up to week 12
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK139 regimen 1 | Experimental |
| |
| AK139 regimen 2 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK139 | Drug | AK139 regimen 1- subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment | Up to week 2 | |
| Incidence of adverse events (AEs) | Up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in daily rTNSS over 2 and 4 weeks of treatment | Up to week 4 | |
| Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment | Up to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoqin Wang | Contact | +86 (0760) 8987 3999 | global.trials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tong-Ren hospital | Beijing | China |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| AK139 |
| Drug |
AK139 regimen 2- subcutaneous injection |
|
| Placebo | Drug | Placebo-subcutaneous injection |
|
| Serum AK139 concentration | Up to week 12 |
| Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. | Up to week 12 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |