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The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1905 Injection | Experimental |
| |
| SHR-1905 Placebo Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905 Injection | Drug | SHR-1905 Injection |
| |
| SHR-1905 Placebo Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal polyp scores (NPS) | Change from baseline in NPS at Week 24. | Baseline to Week 24 |
| Nasal Congestion Scores (NCS) | from baseline in NPS at Week 24. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Lund Mackay score (LMK) from baseline on sinus CT scan | Baseline to Week 24 | |
| Loss of smell | Baseline to Week 24 | |
| Proportion of subjects with NPS≤1 point per nostril |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HuanHuan Huang | Contact | +0518-81220121 | huanhuan.huang.hh30@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & Ent Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| Drug |
SHR-1905 Placebo Injection |
|
| Baseline to Week 24 |
| Sino-nasal outcome test-22 (SNOT-22) scores | Baseline to Week 24 |
| Total symptoms score (TSS) | Baseline to Week 24 |