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

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: Completed
• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Intervention / Treatment: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)

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: Interventional
• Enrollment (Actual): 747
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in PASI 90	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	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

Outcome Measure	Measure Description	Time Frame
Patients achieving PASI 75 at 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	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	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	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	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 to PASI 75/90 response within 12 weeks	From week 0 to week 12
Time to sPGA 0/1 response	Time to sPGA 0/1 response within 12 weeks	From week 0 to week 12
Patients achieving PASI 90 at 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	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

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Immunologic Factors; Physiological Effects of Drugs; Antibodies; Antibodies, Monoclonal
• Other Study ID 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