Back to resultsA Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HS-10374 tablets 1mg
HS-10374 tablets 5mg
HS-10374-matched placebo tablets
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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
Sites / Locations
- Huashan Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HS-10374 Dose 1
HS-10374 Dose 2
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
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.
Number of participants with abnormalities of vital signs
Vital signs measured include blood pressure, pulse rate, and temperature.
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.
Incidence of clinically significant changes in electrocardiogram (ECG)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
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.
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.
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.
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.
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.
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.
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.
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).
Ctrough
Trough observed plasma concentration.
Full Information
NCT ID
NCT06077331
First Posted
August 24, 2023
Last Updated
October 8, 2023
Sponsor
Hansoh BioMedical R&D Company
1. Study Identification
Unique Protocol Identification Number
NCT06077331
Brief Title
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
Official Title
A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hansoh BioMedical R&D Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HS-10374 Dose 1
Arm Type
Experimental
Arm Title
HS-10374 Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HS-10374 tablets 1mg
Intervention Description
Administered orally QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
HS-10374 tablets 5mg
Intervention Description
Administered orally QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
HS-10374-matched placebo tablets
Intervention Description
Administered orally QD for 12 weeks
Primary Outcome Measure Information:
Title
Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Number of participants with clinical laboratory abnormalities
Description
Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.
Time Frame
Baseline to Week 16
Title
Number of participants with abnormalities of vital signs
Description
Vital signs measured include blood pressure, pulse rate, and temperature.
Time Frame
Baseline to Week 16
Title
Number of participants with abnormalities of physical examination
Description
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
Title
Incidence of clinically significant changes in electrocardiogram (ECG)
Description
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Time Frame
Baseline to Week 16
Title
Proportion of patients with sPGA 0/1 at specified time points
Description
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
Title
PASI 50 response rates at specified time points
Description
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
Title
PASI 75 response rates at specified time points
Description
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
Title
PASI 90 response rates at specified time points
Description
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
Title
PASI 100 response rates at specified time points
Description
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
Title
Change from baseline in PASI scores at specified time points
Description
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
Title
Change from baseline in BSA at specified time points
Description
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
Title
Change from baseline in DLQI scores at specified time points
Description
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
Title
Ctrough
Description
Trough observed plasma concentration.
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinghua Xu, PhD
Phone
13818978539
Email
xjhhsyy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhua Xu
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yangfeng Ding
Organizational Affiliation
Shanghai Dermatology Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chao Ci
Organizational Affiliation
The First Affiliated Hospital of Wannan Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weili Pan
Organizational Affiliation
Zhejiang Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shiqin Tao
Organizational Affiliation
Wuxi Second People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yayu Hu
Organizational Affiliation
Taizhou University Affiliated Municipal Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tianhong Xu
Organizational Affiliation
Hangzhou Third People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhu Shen
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mingkai Ji
Organizational Affiliation
The Second Affiliated Hospital of Xiamen Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chao Ji
Organizational Affiliation
First Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Guo
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaohua Wang
Organizational Affiliation
Dermatology Hospital of Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoyong Zhou
Organizational Affiliation
Wuhan First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zudong Meng
Organizational Affiliation
Shiyan City People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fengming Hu
Organizational Affiliation
Jiangxi Dermatology Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rong Xiao
Organizational Affiliation
The Second Xiangya Hospital, Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu Wang
Organizational Affiliation
Affiliated Hospital of Guizhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tiechi Lei
Organizational Affiliation
Wuhan University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanyan Feng
Organizational Affiliation
Chengdu Second people's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rixin Chen
Organizational Affiliation
Nanyang city first People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunshui Yu
Organizational Affiliation
Suining Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaojing Kang
Organizational Affiliation
Xinjiang Autonomous Region People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aijun Chen
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianguo Li
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Zhou
Organizational Affiliation
The First Affiliated Hospital of Xi 'an Jiaotong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Songmei Geng
Organizational Affiliation
The Second Affiliated Hospital of Xi 'an Jiaotong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guoqiang Zhang
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinsuo Duan
Organizational Affiliation
The Affiliated Hospital of Chengde Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linfeng li
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunlei Zhang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shifa Zhang
Organizational Affiliation
North East Central International Hospital Limited
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shanshan Li
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuzhen Li
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Organizational Affiliation
Shenyang Hospital of Integrated Chinese and Western Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinghua Gao
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Xu, PhD
Phone
+86-13818978539
Email
xjhhsyy@163.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
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