A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis

December 8, 2025 updated by: Shanghai Junshi Bioscience Co., Ltd.

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of JS005 in 702 adult patients with moderate-to-severe chronic plaque psoriasis

Study Overview

Status

Status

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

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

The study consisted of four periods: screening period (up to 4 weeks), induction period (12 weeks), maintenance period (40 weeks) and follow-up period (8 weeks). This study planned to recruit 702 subjects, who were randomized into JS005 300mg group (234 subjects), JS005 150mg group (234 subjects) and placebo group (234 subjects) at a ratio of 1:1:1, and were stratified by whether they had previsouly received biologic treatments (continuous biologic treatment for ≥3 months at recommended doses or intolerance for safety reasons) and body weight (≥70 kg or < 70 kg).

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 (Actual)

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.
747

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 3

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.
  • Name: Jianzhong Zhang, M.D.
  • Phone Number: 8618001315877
  • Email: Rmzjz@126.com

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 102218
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 100044
        • Beijing Tongren Hospital Affiliated to Capital Medical University
      • Beijing, Beijing Municipality, China, 100044
        • China-Japan Friendship Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100864
        • Ningbo Huamei Hospital, University of Chinese Academy of Sciences
      • Beijing, Beijing Municipality, China, 101199
        • Beijing Luhe Hospital Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361023
        • The Second Affiliated Hospital of Xiamen medical college
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou university second hospital
    • Guangdong
      • Dongguan, Guangdong, China, 523018
        • Dongguan People's Hospital
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 518107
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital
    • Hebei
      • Chengde, Hebei, China
        • The Affiliated Hospital of Chengde Medical College
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University
      • Xingtai, Hebei, China, 054031
        • Xingtai People's Hospital
    • Henan
      • Nanyang, Henan, China, 473000
        • Nanyang city first People's Hospital
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Xinxiang Medical College
    • Hubei
      • Jingzhou, Hubei, China, 434020
        • Jingzhou Central Hospital
      • Shiyan, Hubei, China, 442000
        • Shiyan City People's Hospital
      • Wuhan, Hubei, China, 430060
        • Wuhan University People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • The Second Xiangya Hospital, Central South University
      • Changsha, Hunan, China, 410013
        • Xiangya Third Hospital, Central South University
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • Lianyungang First People's Hospital
      • Suzhou, Jiangsu, China, 215123
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214002
        • Wuxi Second People's Hospital
      • Yancheng, Jiangsu, China, 224006
        • Yancheng First People's Hospital
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • The First Affiliated Hospital of Gannan Medical College
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330000
        • Jiangxi Dermatology Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • Bethune First Hospital of Jilin University
    • Liaoning
      • Panjin, Liaoning, China, 124011
        • Panjin Liao oil precious stone flower hospital
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital Affiliated to China Medical University
      • Shenyang, Liaoning, China, 110021
        • Shenyang Hospital of Integrated Chinese and Western Medicine
      • Shenyang, Liaoning, China
        • North East Central International Hospital Limited
    • Neimenggu
      • Baotou, Neimenggu, China, 014040
        • Baotou Central Hospital
    • Neimengu
      • Baotou, Neimengu, China, 010000
        • Inner Mongolia Baotou Steel Hospital
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Ningxia Medical University General Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
      • Jinan, Shandong, China, 250000
        • Shandong Dermatology Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200050
        • Shanghai Dermatology Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • The Second Hospital of Shanxi Medical University City:Taiyuan
      • Xian, Shanxi, China, 710004
        • Medicine School of Xi'an Jiaotong University
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, Sichuan, China, 610017
        • Chengdu Second People's Hospital
      • Suining, Sichuan, China, 629000
        • Suining Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300120
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310006
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, China, 310002
        • Hangzhou Third People's Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Jiaxing, Zhejiang, China, 314001
        • The First Hospital of Jiaxing
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

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. Subjects voluntarily particpate in this clinical study and sign the informed consent form.
  2. Male and female patients aged 18-75 years at the time of screening (both inclusive).
  3. Fertile female subjects must be willing to use a highly effective contraceptive method during the study period and 20 weeks (expected 5 half-lives) after the last study drug administration and have a negative pregnancy test during the screening period and prior to randomization.

Exclusion Criteria:

  1. Pregnant and lactating women.
  2. A history of inflammatory bowel disease or other conditions with a high risk of perforation (e.g., severe gastrointestinal ulcers, etc.) or with other active autoimmune diseases (e.g., systemic lupus erythematosus, Sarcoidosis, etc.).
  3. Have a type of psoriasis other than chronic plaque psoriasis (e.g., pustular, erythrodermic, and guttate psoriasis), drug-induced psoriasis, or have an active inflammatory skin disease other than psoriasis
  4. Use of phototherapy, including but not limited to ultraviolet A phototherapy (with or without psoralens), ultraviolet B phototherapy, or excimer laser within 4 weeks prior to randomization. Subjects are unwilling to avoid excessive sunlight exposure within 4 weeks prior to randomization and during the study period;
  5. A (current) history of systemic infection or serious infection requiring hospitalization and/or intravenous anti-infective therapy (e.g., antibiotics, antifungal agents, antiviral agents) within 12 weeks prior to randomization; a history of any active infection, other than common upper respiratory infections, within 2 weeks prior to randomization;

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: Quadruple

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.
Placebo Comparator: Placebo
Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)
JS005/placebo
Experimental: JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)
Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)
JS005/placebo
Experimental: JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)
Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)
JS005/placebo

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
Change in PASI 90
Time Frame: From week 0 to week 12
The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
From week 0 to week 12
Change in sPGA
Time Frame: From week 0 to week 12
The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12.
From week 0 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
Patients achieving PASI 75 at Week 12
Time Frame: From week 0 to week 12
The proportion of patients who achieved at least 75% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
From week 0 to week 12
Patients achieving PASI 100 at Week 12
Time Frame: From week 0 to week 12
The proportion of patients who achieved at least 100% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
From week 0 to week 12
Proportion of subjects with a sPGA score of 0 at week 12
Time Frame: From week 0 to week 12
The proportion of patients who achieved at least 0 at week 12
From week 0 to week 12
Proportion of subjects with a DLQI score of 0/1 at week 12
Time Frame: From week 0 to week 12
The proportion of patients who with a DLQI score at least 0/1 at week 12
From week 0 to week 12
Patients achieving PASI 75 at Week 52
Time Frame: From week 0 to week 52
Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52
From week 0 to week 52
Time to PASI 75/90 response
Time Frame: From week 0 to week 12
Time to PASI 75/90 response within 12 weeks
From week 0 to week 12
Time to sPGA 0/1 response
Time Frame: From week 0 to week 12
Time to sPGA 0/1 response within 12 weeks
From week 0 to week 12
Patients achieving PASI 90 at Week 52
Time Frame: From week 0 to week 52
Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52
From week 0 to week 52
Patients achieving PASI 100 at Week 52
Time Frame: From week 0 to week 52
Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52
From week 0 to week 52

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.
Shanghai Junshi Bioscience Co., Ltd.

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.
August 28, 2023

Primary Completion (Actual)

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.
August 20, 2025

Study Completion (Actual)

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.
September 3, 2025

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).
July 27, 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.
July 27, 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.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

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 16, 2025

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.
December 8, 2025

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.
December 1, 2025

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.
  • JS005-005-III-PsO

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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