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This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10374 Dose 1 | Experimental |
| |
| HS-10374 Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10374 6mg tablets | Drug | Administered orally QD for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12 | 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 12 |
| 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 16 | |
| Number of participants with clinical laboratory abnormalities | Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, C-reactive protein, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuling Shi, MD | Contact | (0086)021-61833000 | shiyuling1973@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuling Shi, MD | Shanghai Dermatology Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | 200443 | 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 | Administered orally QD for 12 weeks |
|
| Baseline to Week 16 |
| Incidence of clinically significant changes in electrocardiogram (ECG) | ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval. | Baseline to Week 16 |
| 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 16 |
| Number of participants with abnormalities of vital signs | Vital signs measured include blood pressure, pulse rate, and temperature. | Baseline to Week 16 |
| 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 16 |
| Proportion of patients achieving BSA 75 response at specified time points | Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. BSA 75 response is defined as 75% or greater improvement in BSA score from baseline. | Baseline to Week 16 |
| Change from baseline in BSA at specified time points | Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. | Baseline to Week 16 |
| Proportion of patients who achieved BSA ≤ 1% at specified time points | Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. | Baseline to Week 16 |
| Change from baseline in PASI 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. | Baseline to Week 16 |
| Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points | Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. | Baseline to Week 16 |
| Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points | 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 |
| Change from baseline in DLQI scores at specified time points | 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 16 |