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This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of the sinus mucosa. Chronic rhinosinusitis can be clinically divided into chronic rhinosinusitis without nasal polyps (CRSsNP) and chronic sinusitis with nasal polyps (CRSwNP), with an incidence ratio between the two of about 4:1. Patients with CRSwNP usually show more severe clinical symptoms and are more likely to relapse after surgery. The overall prevalence of chronic rhinosinusitis in our country is 8%, of which 11.2% are accompanied by asthma. The prevalence of chronic rhinosinusitis with nasal polyps (CRSwNP) is 1.1%. With changes in the living environment and acceleration of urbanization in China, the overall morbidity is estimated to keep rising.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 220 mg Group | Experimental | CM326 220 mg, subcutaneous (SC) |
|
| 440 mg Group | Experimental | CM326 440 mg, subcutaneous (SC) |
|
| placebo | Placebo Comparator | matched placebo, subcutaneous (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Biological | CM326 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24. | Up to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang | Beijing Tong-Ren hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, CMU | Beijing | Beijing Municipality | China |
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| Placebo |
| Drug |
Placebo |
|