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This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vunakizumab (IL-17A inhibitor) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vunakizumab (IL-17A inhibitor) | Drug | Vunakizumab (IL-17A inhibitor) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90). | Three months | |
| Proportion of subjects achieving sPGA 0/1 response at week 12. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52. | One month, Three months,Twelve months | |
| The time when subjects reached PASI 75 and PASI 90 within 12 weeks | Three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haixue Dai | Contact | +86 18006296526 | haixue.dai@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| The time when subjects reached PASI 75, PASI 90, PASI 100 within 52 weeks. | Twelve months |
| Changes in PASI scores relative to baseline at each visit during 52 weeks. | Twelve months |
| Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52. | One month, Three months, Six months,Twelve months |