Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of Patients With Moderate-to-Severe Atopic Dermatitis

A Multi-center, Randomized, Double Blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of LW402 Tablets in Patients With Moderate-to-severe Atopic Dermatitis.

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.

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).