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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Longwood Biopharmaceuticals Co., Ltd.

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • LW402
  • Placebo

Treatment groups

480 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Lead sponsor

Tigermed Consulting Co., Ltd

Collaborator