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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10374 Dose 1 | Experimental |
| |
| HS-10374 Dose 2 | Experimental |
| |
| Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10374 tablets 1mg | Drug | Administered orally QD for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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. | 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, high-sensitivity C-reactive protein, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinghua Xu, PhD | Contact | 13818978539 | xjhhsyy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinhua Xu | Huashan Hospital | Principal Investigator |
| Yangfeng Ding | Shanghai Dermatology Hospital | Principal Investigator |
| Chao Ci |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | 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 tablets 5mg | Drug | Administered orally QD for 12 weeks |
|
| HS-10374-matched placebo tablets | Drug | Administered orally QD for 12 weeks |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. | 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. | 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. | 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. | 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. | 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 |
| 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 |
| Ctrough | Trough observed plasma concentration. | Baseline to Week 12 |
| First Affiliated Hospital of Wannan Medical College |
| Principal Investigator |
| Weili Pan | Zhejiang Provincial People's Hospital | Principal Investigator |
| Shiqin Tao | Wuxi No. 2 People's Hospital | Principal Investigator |
| Yayu Hu | Taizhou University Affiliated Municipal Hospital | Principal Investigator |
| Tianhong Xu | The Third People's Hospital of Hangzhou | Principal Investigator |
| Zhu Shen | Guangdong Provincial People's Hospital | Principal Investigator |
| Mingkai Ji | Second Affiliated Hospital of Xiamen Medical College | Principal Investigator |
| Chao Ji | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Qing Guo | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Xiaohua Wang | Dermatology Hospital of Southern Medical University | Principal Investigator |
| Xiaoyong Zhou | Wuhan First Hospital | Principal Investigator |
| Zudong Meng | Shiyan City People's Hospital | Principal Investigator |
| Fengming Hu | Jiangxi Dermatology Hospital | Principal Investigator |
| Rong Xiao | The Second Xiangya Hospital, Central South University | Principal Investigator |
| Yu Wang | The Affiliated Hospital Of Guizhou Medical University | Principal Investigator |
| Tiechi Lei | Wuhan University People's Hospital | Principal Investigator |
| Yanyan Feng | Chengdu Second people's hospital | Principal Investigator |
| Rixin Chen | Nanyang city first People's Hospital | Principal Investigator |
| Chunshui Yu | Suining Central Hospital | Principal Investigator |
| Xiaojing Kang | Xinjiang Autonomous Region People's Hospital | Principal Investigator |
| Aijun Chen | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Jianguo Li | Henan Provincial People's Hospital | Principal Investigator |
| Yan Zhou | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Songmei Geng | The Second Affiliated Hospital of Xi 'an Jiaotong University | Principal Investigator |
| Guoqiang Zhang | The First Hospital of Hebei Medical University | Principal Investigator |
| Xinsuo Duan | The Affiliated Hospital of Chengde Medical College | Principal Investigator |
| Linfeng li | Beijing Friendship Hospital | Principal Investigator |
| Chunlei Zhang | Peking University Third Hospital | Principal Investigator |
| Shifa Zhang | North East Central International Hospital Limited | Principal Investigator |
| Shanshan Li | The First Hospital of Jilin University | Principal Investigator |
| Yuzhen Li | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Xiaodong Sun | Shenyang Hospital of Integrated Chinese and Western Medicine | Principal Investigator |
| Xinghua Gao | First Hospital of China Medical University | Principal Investigator |