A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
NCT ID: NCT06077331
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-09-28
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HS-10374 Dose 1
HS-10374 tablets 1mg
Administered orally QD for 12 weeks
HS-10374 tablets 5mg
Administered orally QD for 12 weeks
HS-10374-matched placebo tablets
Administered orally QD for 12 weeks
HS-10374 Dose 2
HS-10374 tablets 1mg
Administered orally QD for 12 weeks
HS-10374 tablets 5mg
Administered orally QD for 12 weeks
Placebo
HS-10374-matched placebo tablets
Administered orally QD for 12 weeks
Interventions
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HS-10374 tablets 1mg
Administered orally QD for 12 weeks
HS-10374 tablets 5mg
Administered orally QD for 12 weeks
HS-10374-matched placebo tablets
Administered orally QD for 12 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Hansoh BioMedical R&D Company
INDUSTRY
Responsible Party
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Principal Investigators
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Jinhua Xu
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Yangfeng Ding
Role: PRINCIPAL_INVESTIGATOR
Shanghai Dermatology Hospital
Chao Ci
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Wannan Medical College
Weili Pan
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Shiqin Tao
Role: PRINCIPAL_INVESTIGATOR
Wuxi No. 2 People's Hospital
Yayu Hu
Role: PRINCIPAL_INVESTIGATOR
Taizhou University Affiliated Municipal Hospital
Tianhong Xu
Role: PRINCIPAL_INVESTIGATOR
The Third People's Hospital of Hangzhou
Zhu Shen
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Mingkai Ji
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Xiamen Medical College
Chao Ji
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Qing Guo
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Xiaohua Wang
Role: PRINCIPAL_INVESTIGATOR
Dermatology Hospital of Southern Medical University
Xiaoyong Zhou
Role: PRINCIPAL_INVESTIGATOR
Wuhan First Hospital
Zudong Meng
Role: PRINCIPAL_INVESTIGATOR
Shiyan City People's Hospital
Fengming Hu
Role: PRINCIPAL_INVESTIGATOR
Jiangxi Dermatology Hospital
Rong Xiao
Role: PRINCIPAL_INVESTIGATOR
The Second Xiangya Hospital, Central South University
Yu Wang
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Guizhou Medical University
Tiechi Lei
Role: PRINCIPAL_INVESTIGATOR
Wuhan University People's Hospital
Yanyan Feng
Role: PRINCIPAL_INVESTIGATOR
Chengdu Second people's hospital
Rixin Chen
Role: PRINCIPAL_INVESTIGATOR
Nanyang city first People's Hospital
Chunshui Yu
Role: PRINCIPAL_INVESTIGATOR
Suining Central Hospital
Xiaojing Kang
Role: PRINCIPAL_INVESTIGATOR
Xinjiang Autonomous Region People's Hospital
Aijun Chen
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Jianguo Li
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Yan Zhou
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Xi 'an Jiaotong University
Songmei Geng
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Xi 'an Jiaotong University
Guoqiang Zhang
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Hebei Medical University
Xinsuo Duan
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Chengde Medical College
Linfeng li
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Chunlei Zhang
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Shifa Zhang
Role: PRINCIPAL_INVESTIGATOR
North East Central International Hospital Limited
Shanshan Li
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Yuzhen Li
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Harbin Medical University
Xiaodong Sun
Role: PRINCIPAL_INVESTIGATOR
Shenyang Hospital of Integrated Chinese and Western Medicine
Xinghua Gao
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jinhua Xu, PhD
Role: primary
Other Identifiers
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HS-10374-201
Identifier Type: -
Identifier Source: org_study_id