A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: HS-10374 tablets 1mg; Drug: HS-10374 tablets 5mg; Drug: HS-10374-matched placebo tablets

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinghua Xu, PhD; Phone Number: 13818978539; Email: xjhhsyy@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital of Fudan University
      • Contact: Jinhua Xu, PhD; Phone Number: +86-13818978539; Email: xjhhsyy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects between the ages of 18-70 years
2. Diagnosis of plaque psoriasis for at least 6 months
3. Eligible for phototherapy or systemic therapy
4. Plaque covering ≥ 10% of BSA
5. PASI ≥ 12, sPGA ≥3

Exclusion Criteria:

1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis
2. Recent history of infection, history or risk of serious infection
3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
4. Any condition possibly affecting the PK process of the study drug
5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis
6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
7. 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
8. Have received the prohibited treatment during the protocol required washout period
9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo	Drug: HS-10374-matched placebo tablets; Administered orally QD for 12 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: HS-10374-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No