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This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.
This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | CM310, subcutaneous |
|
| Group B | Experimental | CM310, subcutaneous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Biological | IL-4Rα monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving EASI-75 | Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score). | up to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |