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This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM310 group A | Experimental | CM310 injection, subcutaneous injection, once every 3 weeks. |
|
| CM310 group B | Experimental | CM310 injection, subcutaneous injection, once every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Biological | CM310 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence of adverse events. | up to week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital Capital Medical University | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41284735 | Derived | Zhao M, Xu Z, Wu L, Wei Z, Yang B, Lin Z, Ding Y, Hu G, Wang H, Qian Q, Ran Q, Li X, Xu Y, Xu Y, Huang Y, Jia Y, Chen B, Ma L. Safety and efficacy of stapokibart, an anti-interleukin-4 receptor alpha monoclonal antibody, in children aged 6-11 years with moderate-to-severe atopic dermatitis: an open-label single-arm phase Ib/IIa trial. Br J Dermatol. 2026 Mar 19;194(4):621-628. doi: 10.1093/bjd/ljaf455. |
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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 |