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It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase Ⅲ comparative study to evaluate the efficacy and safety of QL2108 to Dupixent® in adult subjects with moderate-to-severe atopic dermatitis. A total of 520 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2108 injection or Dupixent®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2108 injection | Experimental | QL2108 injection; 300mg/2.0mL; subcutaneous injection |
|
| Dupixent® | Active Comparator | Dupixent®; 300mg/2.0mL; subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL2108 injection | Drug | 300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving EASI-75 at week 16. | EASI-75 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving EASI-75 at week 52 | EASI-75 | 52 weeks |
| Proportion of patients achieving IGA-TS (IGA score was 0 or 1 and decreased by ≥2 points from baseline) at week 16 and week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wangwang zhi, Project Manager | Contact | +086-17761716313 | wangwang.zhi@qilu-pharma.com | |
| Mengli Jiang | Contact | +086-15866209831 | mengli.jiang@qilu-pharma.com |
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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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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| Dupixent® | Drug | 300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection |
|
IGA-TS
| 16 weeks and 52 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |