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

Last updated: January 27, 2026
Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

LW402

Placebo

Clinical Study ID

NCT07370909
LW402-III-02
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Subjects voluntarily provided informed consent and agreed to participate in thestudy.

  • Gender: no restrictions; Age: 18 to 75 years inclusive (as of the date of signingthe informed consent form).

  • At screening, subjects met the Hanifin-Rajka diagnostic criteria for atopicdermatitis (AD) (Appendix 4) and had a documented AD history of ≥1 year prior toscreening.

  • At screening and baseline visits, subjects were required to have moderate-to-severeatopic 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

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 atopicdermatitis (AD) (e.g., systemic lupus erythematosus [SLE], inflammatory boweldisease [IBD], Felty's syndrome, scleroderma, inflammatory myopathy, otherconnective tissue diseases, overlap syndrome) or other skin conditions that mayinterfere with AD assessment (e.g., contact dermatitis, psoriasis).

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: LW402
Phase: 3
Study Start date:
January 30, 2026
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Peking University People's Hospital

    Beijing 1816670,
    China

    Site Not Available

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