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This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.
This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10374 | Experimental | Subjects will receive HS-10374 from Week 0 through Week 52. |
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| Placebo | Placebo Comparator | Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10374 6mg tablets | Drug | Specified dose of HS-10374 tablets administered orally QD on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving PASI 75 response at Week 16 | Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline. | Baseline to Week 16 |
| Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16 | Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation | Baseline to Week 56 | |
| Number of participants with clinical laboratory abnormalities | Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinhua Xu, MD | Contact | (+86)13818978539 | xjhhsyy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| HS-10374-matched placebo tablets | Drug | Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days |
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| Baseline to Week 56 |
| Incidence of clinically significant changes in electrocardiogram (ECG) | ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval. | Baseline to Week 56 |
| Number of participants with abnormalities of physical examination | Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc. | Baseline to Week 56 |
| Number of participants with abnormalities of vital signs | Vital signs measured include blood pressure, pulse rate, and temperature. | Baseline to Week 56 |
| PASI 75 response rates at specified time points | Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline. | Baseline to Week 56 |
| PASI 90 response rates at specified time points | Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 response is defined as 90% or greater improvement in PASI score from baseline. | Baseline to Week 56 |
| PASI 100 response rates at specified time points | Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 response is defined as 100% improvement in PASI score from baseline. | Baseline to Week 56 |
| Proportion of patients with sPGA 0/1 at specified time points | Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively. | Baseline to Week 56 |
| Proportion of patients with sPGA 0 at specified time points | Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 means "clear". | Baseline to Week 56 |
| Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1 | Psoriasis symptoms and signs diary (PSSD) is an 11-item patient-reported instrument. It assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated from 0 (absent) to 10 (worst imaginable). Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. | Baseline to Week 56 |
| Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2 | The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment). | Baseline to Week 56 |
| Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3 | Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively. | Baseline to Week 16 |
| Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3 | Physician's global assessment of fingernails (PGA-F) is a scale used to assess a patient's fingernail psoriasis. Ten fingernails on the hand will be globally evaluated separately for nail bed and nail matrix disease on a scale of 0 to 4. The overall global assessment of nails is the worse of the nail bed and nail matrix assessment. A PGA-F score of 0 or 1 means "clear" or "minimal" respectively. | Baseline to Week 16 |
| Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3 | Palmoplantar PGA (pp-PGA) is a scale performed by investigators to assess a patient's palmoplantar psoriasis lesions on a scale of 0 to 4. A pp-PGA score of 0 or 1 means "clear" or "almost clear" respectively. | Baseline to Week 16 |