Study of LW402 in Moderate-to-Severe Atopic Dermatitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of LW402 in Patients With Moderate-to-Severe Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07186387

Enrollment

144

Registered

2025-09-22

Start date

2023-05-11

Completion date

2025-02-13

Last updated

2025-10-02

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

Conditions

Atopic Dermatitis (AD)

Keywords

Moderate-to-severe

Brief summary

This is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients with moderate-to-severe atopic dermatitis.

Detailed description

The study consists of an up-to-4-week screening period, a 12-week double-blind treatment period and a 4-week safety follow-up period.

Interventions

DRUGLW402

LW402 tablets

DRUGLW402 placebo

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

* Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline

Exclusion criteria

* Not enough washing-out period for previous therapy. Concurrent disease/status which may potentially affect the efficacy/safety judgement. pregnancy. Other.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of participants achieving EASI-50 at week 12	12 weeks	Proportion of participants achieving EASI-50 (≥50% reduction from baseline in Eczema Area and Severity Index score) at week 12. The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe).

Secondary

Measure	Time frame	Description
Proportion of participants achieving EASI-75 at week 12	12 weeks	Proportion of participants achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 12.
Proportion of participants with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 12	12 weeks	Proportion of participants with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	16 weeks	Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
PD: pSTAT3 and pSTAT5 inhibition rates	12 weeks	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026