Clinical trial NCT06077331: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
timeFrame: Baseline to Week 16
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Baseline to Week 16
measure: Number of participants with abnormalities of vital signs
timeFrame: Baseline to Week 16
measure: Number of participants with abnormalities of physical examination
timeFrame: Baseline to Week 16
measure: Incidence of clinically significant changes in electrocardiogram (ECG)
timeFrame: Baseline to Week 16
measure: Proportion of patients with sPGA 0/1 at specified time points
timeFrame: Baseline to Week 16
measure: PASI 50 response rates at specified time points
timeFrame: Baseline to Week 16
measure: PASI 75 response rates at specified time points
timeFrame: Baseline to Week 16
measure: PASI 90 response rates at specified time points
timeFrame: Baseline to Week 16
measure: PASI 100 response rates at specified time points
timeFrame: Baseline to Week 16
measure: Change from baseline in PASI scores at specified time points
timeFrame: Baseline to Week 16
measure: Change from baseline in BSA at specified time points
timeFrame: Baseline to Week 16
measure: Change from baseline in DLQI scores at specified time points
timeFrame: Baseline to Week 16
measure: Ctrough
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jinhua Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Dermatology Hospital
name: Yangfeng Ding
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Wannan Medical College
name: Chao Ci
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Provincial People's Hospital
name: Weili Pan
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Second People's Hospital
name: Shiqin Tao
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou University Affiliated Municipal Hospital
name: Yayu Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third People's Hospital of Hangzhou
name: Tianhong Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Zhu Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Xiamen Medical College
name: Mingkai Ji
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Fujian Medical University
name: Chao Ji
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Qing Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Hospital of Southern Medical University
name: Xiaohua Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan First Hospital
name: Xiaoyong Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiyan City People's Hospital
name: Zudong Meng
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangxi Dermatology Hospital
name: Fengming Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Xiangya Hospital, Central South University
name: Rong Xiao
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Guizhou Medical University
name: Yu Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan University People's Hospital
name: Tiechi Lei
role: PRINCIPAL_INVESTIGATOR
affiliation: Chengdu Second people's hospital
name: Yanyan Feng
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanyang city first People's Hospital
name: Rixin Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Suining Central Hospital
name: Chunshui Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinjiang Autonomous Region People's Hospital
name: Xiaojing Kang
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Aijun Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Jianguo Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Xi 'an Jiaotong University
name: Yan Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Xi 'an Jiaotong University
name: Songmei Geng
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Guoqiang Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Chengde Medical College
name: Xinsuo Duan
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Linfeng li
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Chunlei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: North East Central International Hospital Limited
name: Shifa Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Shanshan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Yuzhen Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenyang Hospital of Integrated Chinese and Western Medicine
name: Xiaodong Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Xinghua Gao
role: PRINCIPAL_INVESTIGATOR
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