A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HS-10374 Dose 1
|
Drug: HS-10374 tablets 1mg
Administered orally QD for 12 weeks
Drug: HS-10374 tablets 5mg
Administered orally QD for 12 weeks
Drug: HS-10374-matched placebo tablets
Administered orally QD for 12 weeks
|
| Experimental: HS-10374 Dose 2
|
Drug: HS-10374 tablets 1mg
Administered orally QD for 12 weeks
Drug: HS-10374 tablets 5mg
Administered orally QD for 12 weeks
|
| Active Comparator: Placebo
|
Drug: HS-10374-matched placebo tablets
Administered orally QD for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12 [Baseline to 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.
Secondary Outcome Measures
- 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 [Baseline to Week 16]
Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.
- Number of participants with abnormalities of vital signs [Baseline to Week 16]
Vital signs measured include blood pressure, pulse rate, and temperature.
- Number of participants with abnormalities of physical examination [Baseline to Week 16]
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
- Incidence of clinically significant changes in electrocardiogram (ECG) [Baseline to Week 16]
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
- Proportion of patients with sPGA 0/1 at specified time points [Baseline to 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.
- PASI 50 response rates at specified time points [Baseline to 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 50 response is defined as 50% or greater improvement in PASI score from baseline.
- PASI 75 response rates at specified time points [Baseline to 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.
- PASI 90 response rates at specified time points [Baseline to 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 90 response is defined as 90% or greater improvement in PASI score from baseline.
- PASI 100 response rates at specified time points [Baseline to 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 100 response is defined as 100% improvement in PASI score from baseline.
- Change from baseline in PASI scores at specified time points [Baseline to 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.
- Change from baseline in BSA at specified time points [Baseline to Week 16]
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.
- Change from baseline in DLQI scores at specified time points [Baseline to Week 16]
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).
- Ctrough [Baseline to Week 12]
Trough observed plasma concentration.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects between the ages of 18-70 years
-
Diagnosis of plaque psoriasis for at least 6 months
-
Eligible for phototherapy or systemic therapy
-
Plaque covering ≥ 10% of BSA
-
PASI ≥ 12, sPGA ≥3
Exclusion Criteria:
-
Diagnosis of non-plaque psoriasis or drug-induced psoriasis
-
Recent history of infection, history or risk of serious infection
-
Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
-
Any condition possibly affecting the PK process of the study drug
-
Evidence of other skin conditions that would interfere with the evaluation of psoriasis
-
History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
-
History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy
-
Have received the prohibited treatment during the protocol required washout period
-
Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huashan Hospital of Fudan University | Shanghai | Shanghai | China | 200040 |
Sponsors and Collaborators
- Hansoh BioMedical R&D Company
Investigators
- Principal Investigator: Jinhua Xu, Huashan Hospital
- Principal Investigator: Yangfeng Ding, Shanghai Dermatology Hospital
- Principal Investigator: Chao Ci, The First Affiliated Hospital of Wannan Medical College
- Principal Investigator: Weili Pan, Zhejiang Provincial People's Hospital
- Principal Investigator: Shiqin Tao, Wuxi Second People's Hospital
- Principal Investigator: Yayu Hu, Taizhou University Affiliated Municipal Hospital
- Principal Investigator: Tianhong Xu, Hangzhou Third People's Hospital
- Principal Investigator: Zhu Shen, Guangdong Provincial People's Hospital
- Principal Investigator: Mingkai Ji, The 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,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, 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, The First Affiliated Hospital of 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-10374-201