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The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1139 injection group | Experimental |
| |
| SHR-1139 injection placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1139 Injection | Drug | SHR-1139 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with at least 90% improvement (PASI 90) in their PASI (Psoriasis Area and Severity Index) score from the baseline. | At week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with at least 75% improvement (PASI 75) in their PASI (Psoriasis Area and Severity Index) score from the baseline. | At week 16. | |
| Proportion of subjects with at least 100% improvement (PASI 100) in their PASI (Psoriasis Area and Severity Index) score from the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | 200435 | China |
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| SHR-1139 Injection Placebo |
| Drug |
SHR-1139 injection placebo. |
|
| At week 16. |
| Adverse events (AEs) | Up to week 64. |
| Serum concentration of SHR-1139. | Up to week 64. |