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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Moderate to Severe Chronic Plaque Psoriasis

Intervention / Treatment
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* Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily particpate in this clinical study and sign the informed consent form. Male and female patients aged 18-75 years at the time of screening (both inclusive). 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: Pregnant and lactating women. 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.). 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 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; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)<br> | Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)<br>* JS005/placebo<br>|
| Experimental: JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)<br> | Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)<br>* JS005/placebo<br>|
| Placebo Comparator: Placebo<br> | Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)<br>* JS005/placebo<br>|

What is the study measuring?
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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 |