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This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 injection | Drug | SHR-1819 injection 300 mg Q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) (per person-year) | Up to 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Event (SAE) during treatment (per person-year) | Up to 60 weeks | |
| Adverse Events of Special Interest (AESI) during treatment (per person-year) | Up to 60 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit |
| Up to 60 weeks |
| Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2) | Up to 60 weeks |
| Proportion of participants with at least 1 remission in this study | Up to 60 weeks |
| Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2) | Up to 60 weeks |
| The concentration of SHR-1819 in serum :Cmax | From the beginning of administration to the 60h week |
| Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819 | From the beginning of administration to the 60th week |