CompletedPhase 3

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

China747 participantsStarted 2023-08-28

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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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;

What they're measuring

Change in PASI 90

Timeframe: From week 0 to week 12

Change in sPGA

Timeframe: From week 0 to week 12

Trial details

NCT IDNCT05975268

SponsorShanghai Junshi Bioscience Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-20

View on ClinicalTrials.gov More Moderate to Severe Chronic Plaque Psoriasis trials