Status:
COMPLETED
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
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Moderate to Severe Chronic Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 chroni...
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 subj...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2025
Estimated Enrollment :
747 Patients enrolled
Trial Details
Trial ID
NCT05975268
Start Date
August 28 2023
End Date
September 3 2025
Last Update
December 16 2025
Active Locations (63)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
2
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100044
4
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100044