This Phase 3, double-blind (sponsor-open), multicenter, placebo-controlled study aims to evaluate the efficacy and safety of oral LW402 tablets in patients with moderate to severe atopic dermatitis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Subjects voluntarily provided informed consent and agreed to participate in the study.
* Gender: no restrictions; Age: 18 to 75 years inclusive (as of the date of signing the informed consent form).
* At screening, subjects met the Hanifin-Rajka diagnostic criteria for atopic dermatitis (AD) (Appendix 4) and had a documented AD history of ≥1 year prior to screening.
* At screening and baseline visits, subjects were required to have moderate-to-severe atopic dermatitis (AD) with all three of the following criteria satisfied:
* Total AD lesion area ≥ 10% of body surface area (BSA)
* Investigator's Global Assessment (IGA) score ≥ 3
* Eczema Area and Severity Index (EASI) score ≥ 16
Exclusion Criteria:
* Subjects with a documented history of hypersensitivity to Janus kinase (JAK) inhibitors.
* Subjects with current or a history of autoimmune diseases other than atopic dermatitis (AD) (e.g., systemic lupus erythematosus \[SLE\], inflammatory bowel disease \[IBD\], Felty's syndrome, scleroderma, inflammatory myopathy, other connective tissue diseases, overlap syndrome) or other skin conditions that may interfere with AD assessment (e.g., contact dermatitis, psoriasis).
Primary outcome measure(s)
Proportion of subjects achieving ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 16 (EASI 75) — Week 16
Proportion of subjects achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a ≥2-point reduction from baseline at Week 16 — Week 16
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
China
Recruiting
More Shanghai Longwood Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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