Oral LW402 for moderate-to-severe atopic dermatitis
Official 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.
Run by Shanghai Longwood Biopharmaceuticals Co., Ltd. · NCT07370909 · Data updated 2026-11-12
This phase 3 study tests whether oral LW402 tablets can help adults with moderate-to-severe atopic dermatitis compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Shanghai Longwood Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07370909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years with a documented history of moderate-to-severe atopic dermatitis, with baseline IGA ≥3 and EASI ≥16, and total lesion area ≥10% of body surface area.
✕Probably not a fit
Patients may not benefit if they do not respond to LW402 or experience adverse effects that require discontinuation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, multicenter trial compares oral LW402 to placebo in adults with moderate-to-severe atopic dermatitis who have had the condition for at least one year. Participants are 18 to 75 years old and must meet established skin severity criteria. The study includes regular safety monitoring and aims to evaluate both efficacy and safety of LW402 over a defined treatment period. A sponsor-open design means the sponsor may be aware of treatment assignment, while investigators remain blinded to reduce bias. The trial is conducted at multiple clinical sites, with primary endpoints likely focusing on changes in skin symptoms and overall disease activity.
Why it matters
Potential benefit: If successful, LW402 could provide a new oral treatment option for adults with moderate-to-severe atopic dermatitis.
How similar studies have gone: Previous studies in similar JAK-inhibitor–related approaches have shown efficacy in atopic dermatitis, but LW402 results are needed to confirm benefit for this agent.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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Peking University People's Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Janzhong Zhang — Peking University People's Hospital
- Study coordinator: Barbara Chen
- Email: barbara@lwbiopharma.com
- Phone: +86-21-63634910
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.