Study of LW402 in Moderate-to-Severe Atopic Dermatitis

NCT07186387 | Completed Phase 2

• 1 other identifier: LW402-II-02
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis (AD)

Keywords

Moderate-to-severe

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving EASI-50 at week 12

  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).

  12 weeks

Secondary Outcomes (4)

• Proportion of participants achieving EASI-75 at week 12

  12 weeks

• 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

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

  16 weeks

• PD: pSTAT3 and pSTAT5 inhibition rates

  12 weeks

Study Arms (4)

LW402 Low Dose

EXPERIMENTAL

LW402 administered orally, BID (low dose)

Drug: LW402

LW402 Medium Dose

EXPERIMENTAL

LW402 administered orally, BID (medium dose)

Drug: LW402

LW402 High Dose

EXPERIMENTAL

LW402 administered orally, BID (high dose)

Drug: LW402

Placebo

PLACEBO COMPARATOR

LW402 placebo administered orally, BID

Drug: LW402 placebo

Interventions

LW402 DRUG

LW402 tablets

LW402 High Dose; LW402 Low Dose; LW402 Medium Dose

LW402 placebo DRUG

LW402 placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Longwood Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: May 11, 2023
• Primary Completion: September 25, 2024
• Study Completion: February 13, 2025
• Last Updated: October 2, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)