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NCT Number: NCT07370909

Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, China

Location contact

Jianzhong Zhang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

LW402

Drug

LW402 tablets

Placebo

Drug

LW402 placebo tablets

Primary outcomes

  1. Proportion of subjects achieving ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 16 (EASI 75)

    Time frame: Week 16

  2. 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

    Time frame: Week 16

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Chen

CONTACT

[email protected]

+86-21-63634910

Sponsors and collaborators

Lead sponsor

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Industry

Collaborators

  • Tigermed Consulting Co., Ltd

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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