Study of LW402 in Moderate-to-Severe Atopic Dermatitis

Shanghai Longwood Biopharmaceuticals Co., Ltd.144 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

144

Conditions

Atopic Dermatitis (AD)

Interventions

LW402DRUG

LW402 tablets

LW402 placeboDRUG

LW402 placebo tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

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).

Time frame: 12 weeks

Secondary Outcomes

Proportion of participants achieving EASI-75 at week 12

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

Time frame: 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

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).

Time frame: 12 weeks

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

Time frame: 16 weeks

PD: pSTAT3 and pSTAT5 inhibition rates

Time frame: 12 weeks

Data from ClinicalTrials.gov

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