This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.
This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Administered orally QD for 12 weeks
Administered orally QD for 12 weeks
Administered orally QD for 12 weeks
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGProportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
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.
Time frame: Baseline to Week 12
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: Baseline to Week 16
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.
Time frame: Baseline to Week 16
Number of participants with abnormalities of vital signs
Vital signs measured include blood pressure, pulse rate, and temperature.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 16
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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.
Time frame: Baseline to Week 16
PASI 50 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 50 response is defined as 50% or greater improvement in PASI score from baseline.
Time frame: Baseline to Week 16
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.
Time frame: Baseline to Week 16
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.
Time frame: Baseline to Week 16
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.
Time frame: Baseline to Week 16
Change from baseline in PASI scores 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline to Week 16
Ctrough
Trough observed plasma concentration.
Time frame: Baseline to Week 12