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
Overview
- Phase
- Phase 3
- Intervention
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Conditions
- Moderate to Severe Chronic Plaque Psoriasis
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 747
- Locations
- 63
- Primary Endpoint
- Change in PASI 90
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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).
Investigators
Eligibility Criteria
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;
Arms & Interventions
JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)
Intervention: JS005 (recombinant humanized monoclonal antibody against IL-17A)
JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)
Intervention: JS005 (recombinant humanized monoclonal antibody against IL-17A)
Placebo
Intervention: JS005 (recombinant humanized monoclonal antibody against IL-17A)
Outcomes
Primary Outcomes
Change in PASI 90
Time Frame: From week 0 to week 12
The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
Change in sPGA
Time Frame: From week 0 to week 12
The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12.
Secondary Outcomes
- Patients achieving PASI 100 at Week 12(From week 0 to week 12)
- Proportion of subjects with a DLQI score of 0/1 at week 12(From week 0 to week 12)
- Time to sPGA 0/1 response(From week 0 to week 12)
- Time to PASI 75/90 response(From week 0 to week 12)
- Patients achieving PASI 75 at Week 12(From week 0 to week 12)
- Proportion of subjects with a sPGA score of 0 at week 12(From week 0 to week 12)
- Patients achieving PASI 75 at Week 52(From week 0 to week 52)
- Patients achieving PASI 90 at Week 52(From week 0 to week 52)
- Patients achieving PASI 100 at Week 52(From week 0 to week 52)