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The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK47388 matching placebo will be administered orally. | Placebo Comparator |
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| HSK47388 dose 1 will be administered orally. | Experimental |
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| HSK47388 dose 2 will be administered orally. | Experimental |
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| HSK47388 dose 3 will be administered orally. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK47388 | Drug | HSK47388 tablets will be administered orally, once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16 | Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HSK47388 and placebo Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 | The percentage of participants with IGA 0/1 and ≥2-grade improvement from baseline at Weeks 16 will be reported. IGA is investigators' assessment of participants' psoriasis at a specific time point, grading overall lesions by induration, erythema, scaling, and categorizing psoriasis as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
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Inclusion Criteria:
Exclusion Criteria:
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| 16 weeks |
| Change From Baseline in Body Surface Area (BSA) at Week 16 | Change from baseline in BSA at Week 16 will be reported. BSA is a common measure of skin disease extent, defined as the percentage of total body surface area affected by the target condition (i.e., plaque psoriasis). | 16 weeks |
| HSK47388 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16 | Change from baseline in total DLQI score at Week 16 will be reported. The DLQI is a dermatology-specific HRQoL instrument designed to assess a disease's impact on participants' HRQoL. It is a 10-item questionnaire evaluating HRQoL over the past week; in addition to overall HRQoL, it assesses 6 quality-of-life domains: symptoms/feelings, daily activities, leisure, work/school performance, personal relationships, and treatment. Total scores range from 0 to 30, with higher scores indicating greater HRQoL impact. | 16 weeks |
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | 20 weeks |