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

Moderate to Severe Chronic Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975268
• Other study ID #: JS005-005-III-PsO
• Status: Recruiting
• Phase: Phase 3
• Start date: August 28, 2023
• Est. completion date: October 10, 2025

Study information

• Verified date: September 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Jianzhong Zhang, M.D.
• Phone: 8618001315877
• Email: Rmzjz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 702
• Est. completion date: October 10, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• JS005 (recombinant humanized monoclonal antibody against IL-17A)
JS005/placebo

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Neimenggu
China	Inner Mongolia Baotou Steel Hospital	Baotou	Neimengu
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing LuHe Hospital Capital Medical University	Beijing	Beijing
China	Beijing Tongren Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Ningbo Huamei Hospital, University of Chinese Academy of Sciences	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Bethune First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital, Central South University	Changsha	Hunan
China	Xiangya Third Hospital, Central South University	Changsha	Hunan
China	The Affiliated Hospital of Chengde Medical College	Chengde	Hebei
China	Chengdu Second People's Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dongguan People's Hospital	Dongguan	Guangdong
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Hangzhou Third People's Hospital	Hangzhou	Zhejiang
China	Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Dermatology Hospital	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Lianyungang First People's Hospital	Lianyungang	Jiangsu
China	Jiangxi Dermatology Hospital	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanyang city first People's Hospital	Nanyang	Henan
China	Panjin Liao oil precious stone flower hospital	Panjin	Liaoning
China	Shanghai Dermatology Hospital	Shanghai	Shanghai
China	North East Central International Hospital Limited	Shenyang	Liaoning
China	Shengjing Hospital affiliated to China Medical University	Shenyang	Liaoning
China	Shenyang Hospital of Integrated Chinese and Western Medicine	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shiyan City People's Hospital	Shiyan	Hubei
China	Suining Central Hospital	Suining	Sichuan
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Hospital of Shanxi Medical University City:Taiyuan	Taiyuan	Shanxi
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan University People's Hospital	Wuhan	Hubei
China	Wuxi Second People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian	Xi'an	Shanxi
China	The Second Affiliated Hospital of Xiamen Medical College	Xiamen	Fujian
China	Medicine School of Xi'an Jiaotong University	Xian	Shanxi
China	Xingtai People's Hospital	Xingtai	Hebei
China	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang	Henan
China	Yancheng First People's Hospital	Yancheng	Jiangsu
China	Ningxia Medical University General Hospital	Yinchuan	Ningxia
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to PASI 75/90 response	Time to PASI 75/90 response within 12 weeks	From week 0 to week 12
Secondary	Time to sPGA 0/1 response	Time to sPGA 0/1 response within 12 weeks	From week 0 to week 12
Secondary	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
Secondary	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