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This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial aimed at evaluating the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SHR-1819 injection in patients with Seasonal Allergic Rhinitis (SAR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 Group | Experimental | SHR-1819 injection. |
|
| SHR-1819 Placebo Group | Placebo Comparator | SHR-1819 injection placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 Injection | Drug | SHR-1819 injection. |
| |
| SHR-1819 Injection Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment. | 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 4 weeks of treatment. | 4 weeks. | |
| Mean percent change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiliu Wang | Contact | +86-0518-82342973 | huiliu.wang.hw330@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100005 | China |
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SHR-1819 compared with placebo.
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| Drug |
SHR-1819 injection placebo. |
|
| 2 and 4 weeks. |
| Mean percent change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Mean change from baseline in the daily AM reflective Total Nasal Symptom Score (AM rTNSS) within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Mean change from baseline in the daily PM reflective Total Nasal Symptom Score (PM rTNSS) within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Mean change and percent change from baseline in the daily pre-morning dose instantaneous Total Nasal Symptom Score (iTNSS) within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Mean change from baseline in the daily/daily AM/daily PM/reflective individual nasal symptom scores (rhinorrhea, nasal congestion, nasal itching, and sneezing) within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Mean change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score within 2 and 4 weeks of treatment. | 2 and 4 weeks. |
| Total number of days without nasal symptoms, without nasal congestion symptoms, and without any symptoms from the baseline visit to the end of Week 2 and Week 4 of treatment. | 2 and 4 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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