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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), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-1905 Injection(dose 1) | Experimental |
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| Treatment group B: SHR-1905 Injection(dose 2) | Experimental |
| |
| Treatment group C: SHR-1905 Injection(dose 3) | Experimental |
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| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905 Injection | Drug | SHR-1905 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal polyp scores (NPS) | Change from baseline in NPS at Week 24. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| NPS | Changes from baseline in NPS from baseline at each evaluation time point. | Baseline to Week 48 |
| Nasal Congestion Scores (NCS) | Changes from baseline in NCS at each evaluation time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & Ent Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
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| SHR-1905 Placebo Injection | Drug | SHR-1905 Placebo Injection |
|
| Baseline to Week 48 |
| Loss of smell | Changes from baseline in scores of loss of smell at each evaluation time point. | Baseline to Week 48 |
| Runny nose/postnasal drip | Change from baseline in scores of runny nose/postnasal drip at each evaluation time point. | Baseline to Week 48 |
| Facial pain and/or pressure | Change from baseline in facial pain and/or pressure scores at each evaluation time point. | Baseline to Week 48 |
| Total symptoms score (TSS) | Changes from baseline in TSS each evaluation time point. | Baseline to Week 48 |
| Sino-nasal outcome test-22 (SNOT-22) scores | Changes from baseline in SNOT-22 scores at each evaluation time point. | Baseline to Week 48 |
| Proportion of subjects exposed to SCS for acute exacerbation of chronic rhinosinusitis (AECRS) over 24 weeks. | Baseline to Week 24 |
| Dose of SCS used for AECRS over 24 weeks (converted to equivalent dose of prednisone). | Baseline to Week 24 |