Clinical trial NCT05975268: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: 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;

Primary outcomes:
measure: Change in PASI 90
timeFrame: From week 0 to week 12
measure: Change in sPGA
timeFrame: From week 0 to week 12
Secondary outcomes:
measure: Patients achieving PASI 75 at Week 12
timeFrame: From week 0 to week 12
measure: Patients achieving PASI 100 at Week 12
timeFrame: From week 0 to week 12
measure: Proportion of subjects with a sPGA score of 0 at week 12
timeFrame: From week 0 to week 12
measure: Proportion of subjects with a DLQI score of 0/1 at week 12
timeFrame: From week 0 to week 12
measure: Patients achieving PASI 75 at Week 52
timeFrame: From week 0 to week 52
measure: Time to PASI 75/90 response
timeFrame: From week 0 to week 12
measure: Time to sPGA 0/1 response
timeFrame: From week 0 to week 12
measure: Patients achieving PASI 90 at Week 52
timeFrame: From week 0 to week 52
measure: Patients achieving PASI 100 at Week 52
timeFrame: From week 0 to week 52
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing LuHe Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The Second Affiliated Hospital of Xiamen Medical College
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Chengde
country: China
facility: The Affiliated Hospital of Chengde Medical College
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Nanyang
country: China
facility: Nanyang city first People's Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Shiyan
country: China
facility: Shiyan City People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Third Hospital, Central South University
state: Hunan
city: Lianyungang
country: China
facility: Lianyungang First People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng First People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Ganzhou
country: China
facility: The First Affiliated Hospital of Gannan Medical College
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Dermatology Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Bethune First Hospital of Jilin University
state: Jilin
city: Panjin
country: China
facility: Panjin Liao oil precious stone flower hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Hospital of Integrated Chinese and Western Medicine
state: Liaoning
city: Shenyang
country: China
facility: North East Central International Hospital Limited
state: Liaoning
city: Baotou
country: China
facility: Baotou Central Hospital
state: Neimenggu
city: Baotou
country: China
facility: Inner Mongolia Baotou Steel Hospital
state: Neimengu
city: Yinchuan
country: China
facility: Ningxia Medical University General Hospital
state: Ningxia
city: Jinan
country: China
facility: Shandong Dermatology Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University City:Taiyuan
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian
state: Shanxi
city: Xian
country: China
facility: Medicine School of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: