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This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM310 group | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Biological | Interleukin-4 receptor(IL-4Rα) monoclonal antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving EASI-75 at week 18 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe). | Up to week 18 |
| Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline | Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). | up to week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of Eczema Area and Severity Index (EASI) score from baseline | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). | up to week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianzhong Zhang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41697953 | Derived | Zhou C, Zhao Y, Zhu G, Wu L, Liu Y, Tao X, Zhao H, Wei Z, Lu W, Li W, Ding Y, Zhu X, Hu G, Cheng H, Xiao R, Man XY, Wang Q, Li S, Zeng T, Wang L, Xu Y, Zhang L, Liu W, Zhao G, Jia Y, Huang Y, Chen B, Zhang J. Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial. Br J Dermatol. 2026 May 19;194(6):1067-1076. doi: 10.1093/bjd/ljag052. |
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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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| placebo |
| Other |
Placebo |
|
| Percent change of NRS score from baseline | The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch) | up to week 18 |
| Body surface area (BSA) of involvement of atopic dermatitis | Change from baseline in percent of BSA | up to week 18 |
| Children Dermatology Life Quality Index (CDLQI) | Changes from baseline in CDLQI | up to week 18 |
| Patient-Oriented Eczema Measure (POEM) | Changes from baseline in POEM | up to week 18 |
| EuroQol Five Dimensions Questionnaire (EQ-5D) | Changes from baseline in EQ-5D | up to week 18 |
| Safety parameters | Incidence of Adverse Event(AE), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | up to week 26 |
| Pharmacokinetics parameters | Trough concentration and exposure of CM310 | up to week 26 |
| Pharmacodynamics | Serum concentration of Thymus and activation regulated chemokine (TARC) , total immunoglobulin E (IgE) and lactate dehydrogenase (LDH) | up to week 26 |
| Immunogenicity | Detection of anti-drug antibody (ADA) | up to week 26 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |