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Completed

NCT Number: NCT07186387

Study of LW402 in Moderate-to-Severe Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LW402

Drug

LW402 tablets

LW402 placebo

Drug

LW402 placebo tablets

Primary outcomes

  1. Proportion of participants achieving EASI-50 at week 12

    Time frame: 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 outcomes

  1. Proportion of participants achieving EASI-75 at week 12

    Time frame: 12 weeks

    Proportion of participants achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 12.

  2. Proportion of participants with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 12

    Time frame: 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).

  3. Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

    Time frame: 16 weeks

    Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  4. PD: pSTAT3 and pSTAT5 inhibition rates

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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