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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06077331
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hansoh BioMedical R&D Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jinhua XuYangfeng DingChao CiWeili PanShiqin TaoYayu HuTianhong XuZhu ShenMingkai JiChao JiQing GuoXiaohua WangXiaoyong ZhouZudong MengFengming HuRong XiaoYu WangTiechi LeiYanyan FengRixin ChenChunshui YuXiaojing KangAijun ChenJianguo LiYan ZhouSongmei GengGuoqiang ZhangXinsuo DuanLinfeng liChunlei ZhangShifa ZhangShanshan LiYuzhen LiXiaodong SunXinghua Gao
Principal Investigator Affiliation Huashan HospitalShanghai Dermatology HospitalThe First Affiliated Hospital of Wannan Medical CollegeZhejiang Provincial People's HospitalWuxi Second People's HospitalTaizhou University Affiliated Municipal HospitalHangzhou Third People's HospitalGuangdong Provincial People's HospitalThe Second Affiliated Hospital of Xiamen Medical CollegeFirst Affiliated Hospital of Fujian Medical UniversitySun Yat-sen Memorial Hospital,Sun Yat-sen UniversityDermatology Hospital of Southern Medical UniversityWuhan First HospitalShiyan City People's HospitalJiangxi Dermatology HospitalThe Second Xiangya Hospital, Central South UniversityAffiliated Hospital of Guizhou Medical UniversityWuhan University People's HospitalChengdu Second people's hospitalNanyang city first People's HospitalSuining Central HospitalXinjiang Autonomous Region People's HospitalFirst Affiliated Hospital of Chongqing Medical UniversityHenan Provincial People's HospitalThe First Affiliated Hospital of Xi 'an Jiaotong UniversityThe Second Affiliated Hospital of Xi 'an Jiaotong UniversityThe First Hospital of Hebei Medical UniversityThe Affiliated Hospital of Chengde Medical CollegeBeijing Friendship HospitalPeking University Third HospitalNorth East Central International Hospital LimitedThe First Hospital of Jilin UniversityThe Second Affiliated Hospital of Harbin Medical UniversityShenyang Hospital of Integrated Chinese and Western MedicineFirst Hospital of China Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: HS-10374 Dose 1

Experimental: HS-10374 Dose 2

Active Comparator: Placebo

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Huashan Hospital of Fudan University, Shanghai, Shanghai, China

Status

Recruiting

Address

Huashan Hospital of Fudan University

Shanghai, Shanghai, 200040

Site Contact

Jinhua Xu, PhD

xjhhsyy@163.com

+86-13818978539

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