Study of LW402 in Moderate-to-Severe Atopic Dermatitis

Shanghai Longwood Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: LW402; Drug: LW402 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07186387

LW402-II-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 4 patient groups, including a placebo group

LW402 Low Dose

Experimental group

Description:

LW402 administered orally, BID (low dose)

Treatment:

Drug: LW402

LW402 Medium Dose

Experimental group

Description:

LW402 administered orally, BID (medium dose)

Treatment:

Drug: LW402

LW402 High Dose

Experimental group

Description:

LW402 administered orally, BID (high dose)

Treatment:

Drug: LW402

Placebo

Placebo Comparator group

Description:

LW402 placebo administered orally, BID

Treatment:

Drug: LW402 placebo