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

NCT06077331 | Unknown Phase 2

• 1 other identifier: HS-10374-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  Baseline to Week 16

• Number of participants with abnormalities of vital signs

  Baseline to Week 16

• Number of participants with abnormalities of physical examination

  Baseline to Week 16

• Incidence of clinically significant changes in electrocardiogram (ECG)

  Baseline to Week 16

Study Arms (3)

HS-10374 Dose 1

EXPERIMENTAL

Drug: HS-10374 tablets 1mg; Drug: HS-10374 tablets 5mg; Drug: HS-10374-matched placebo tablets

HS-10374 Dose 2

EXPERIMENTAL

Drug: HS-10374 tablets 1mg; Drug: HS-10374 tablets 5mg

Placebo

ACTIVE COMPARATOR

Drug: HS-10374-matched placebo tablets

Interventions

HS-10374 tablets 1mg DRUG

Administered orally QD for 12 weeks

HS-10374 Dose 1; HS-10374 Dose 2

HS-10374 tablets 5mg DRUG

Administered orally QD for 12 weeks

HS-10374 Dose 1; HS-10374 Dose 2

HS-10374-matched placebo tablets DRUG

Administered orally QD for 12 weeks

HS-10374 Dose 1; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jinhua Xu

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Yangfeng Ding

  Shanghai Dermatology Hospital

  PRINCIPAL INVESTIGATOR

• Chao Ci

  First Affiliated Hospital of Wannan Medical College

  PRINCIPAL INVESTIGATOR

• Weili Pan

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Shiqin Tao

  Wuxi No. 2 People's Hospital

  PRINCIPAL INVESTIGATOR

• Yayu Hu

  Taizhou University Affiliated Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Tianhong Xu

  The Third People's Hospital of Hangzhou

  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 of 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

  First Affiliated Hospital 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinghua Xu, PhD

CONTACT

13818978539; xjhhsyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: October 11, 2023
• Study Start: September 28, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CN (1)