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This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 Injection Group with Dose 1 | Experimental |
| |
| SHR-1819 Injection Group with Dose 2 | Experimental |
| |
| SHR-1819 Injection Group with Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 Injection | Drug | SHR-1819 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline). | Eczema Area and Severity Index score using the Eczema Area and Severity Index scale. | Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week. | The Itch Numeric Rating Scale score using the Itch Numeric Rating Scale. | Week 24. |
| Adverse events (AEs). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | 510091 | China | ||
| Hangzhou Third People's Hospital |
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| SHR-1819 Injection Blank Preparation | Drug | SHR-1819 injection blank preparation. |
|
| About 42 weeks. |
| The concentration of SHR-1819 in serum. | From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks. |
| Hangzhou |
| Zhejiang |
| 310009 |
| China |