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.
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.
Total AD lesion area ≥ 10% of body surface area (BSA)
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).
Parallel
LW402
DrugLW402 tablets
Placebo
DrugLW402 placebo tablets
Proportion of subjects achieving ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 16 (EASI 75)
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
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Shanghai Longwood Biopharmaceuticals Co., Ltd.
Lead sponsor
Tigermed Consulting Co., Ltd
Collaborator
