Phase II Study of LW402 in Moderate-to-Severe Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis (AD)
• Interventions: Drug: LW402; Drug: LW402 placebo

• Registration Number: NCT07186387
• Lead Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.

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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-11
• Primary Completion: 2024-09-25
• Study Completion: 2025-02-13
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LW402 Low Dose	LW402	LW402 administered orally, BID (low dose)
LW402 Medium Dose	LW402	LW402 administered orally, BID (medium dose)
LW402 High Dose	LW402	LW402 administered orally, BID (high dose)
Placebo	LW402 placebo	LW402 placebo administered orally, BID

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PD: pSTAT3 and pSTAT5 inhibition rates	12 weeks
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.
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.
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).

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China