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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
747
JS005/placebo
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
Time frame: 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.
Time frame: From week 0 to week 12
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From week 0 to week 52
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Beijing, Beijing Municipality, China
Beijing LuHe Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
...and 53 more locations
Time to PASI 75/90 response
Time to PASI 75/90 response within 12 weeks
Time frame: From week 0 to week 12
Time to sPGA 0/1 response
Time to sPGA 0/1 response within 12 weeks
Time frame: 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
Time frame: 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
Time frame: From week 0 to week 52