Study of LW402 in Moderate-to-Severe Atopic Dermatitis

NCT ID: NCT07186387

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2025-02-13

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LW402 Low Dose

LW402 administered orally, BID (low dose)

Group Type EXPERIMENTAL

LW402

Intervention Type DRUG

LW402 tablets

LW402 Medium Dose

LW402 administered orally, BID (medium dose)

Group Type EXPERIMENTAL

LW402

Intervention Type DRUG

LW402 tablets

LW402 High Dose

LW402 administered orally, BID (high dose)

Group Type EXPERIMENTAL

LW402

Intervention Type DRUG

LW402 tablets

Placebo

LW402 placebo administered orally, BID

Group Type PLACEBO_COMPARATOR

LW402 placebo

Intervention Type DRUG

LW402 placebo tablets

Interventions

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LW402

LW402 tablets

Intervention Type DRUG

LW402 placebo

LW402 placebo tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Longwood Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University People's Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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LW402-II-02

Identifier Type: -

Identifier Source: org_study_id

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