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This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-K10 Regimen 1 | Experimental | Administer the drug once every 4 weeks for a total of 6 times |
|
| MG-K10 Regimen 2 | Active Comparator | Administer the drug once every 4 weeks for a total of 6 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG-K10 placebo | Biological | Administer the drug once every 4 weeks for a total of 6 times |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects reaching EASI-75 at 24 weeks of treatment | The percentage of subjects reaching EASI-75 at 24 weeks of treatment | 24 weeks |
| The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment | The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline; | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liming Wu | Contact | 15258567080 | xiaofeng.cai@mabgeek.com | |
| Xiaofeng Cai | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower 5,No.34,Chunxiao Road No.122 Pudong District, Shanghai, 201203.p R. china | Shanghai | Shanghai Municipality | 201203 | 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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| Hangzhou First People's Hospital | Zhejiang | 杭州 | 310000 | China |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |