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

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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07370909

Enrollment

480

Registered

2026-01-27

Start date

2026-03-03

Completion date

2028-12-31

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Atopic Dermatitis

Brief 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.

Interventions

DRUGLW402

LW402 tablets

DRUGPlacebo

LW402 placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Countries

China

Contacts

CONTACTBarbara Chen

barbara@lwbiopharma.com+86-21-63634910

PRINCIPAL_INVESTIGATORJanzhong Zhang

Peking University People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026