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This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 Injection Dose 1 Group | Experimental |
| |
| SHR-1819 Injection Dose 2 Group | Experimental |
| |
| SHR-1819 Injection Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 Injection | Drug | SHR-1819 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from baseline in daily retrospective total nasal symptom score (rTNSS). | Within 2 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from baseline in daily retrospective total nasal symptom score (rTNSS). | Within 4 weeks of treatment. | |
| The mean change rate from baseline in daily retrospective total nasal symptom score (rTNSS). | Within 2 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Bai | Contact | +86-0518-82342973 | xiaoyan.bai.xb1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| SHR-1819 Injection Placebo | Drug | SHR-1819 injection placebo. |
|
| The mean change rate from baseline in daily retrospective total nasal symptom score (rTNSS). | Within 4 weeks of treatment. |
| Adverse events (AEs). | 12 weeks. |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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