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

November 30, 2023 updated by: Hansoh BioMedical R&D Company

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
Time Frame: Baseline to 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of participants with clinical laboratory abnormalities
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
Vital signs measured include blood pressure, pulse rate, and temperature.
Baseline to Week 16
Number of participants with abnormalities of physical examination
Time Frame: Baseline to Week 16
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)
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 12
Trough observed plasma concentration.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hansoh BioMedical R&D Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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