Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of Patients With Moderate-to-Severe Atopic Dermatitis
Recruiting · NCT07370909 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
LW402Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Peking University People's Hospital - Beijing, China