Phase 2: testing LT-002-158 for Atopic Dermatitis (AD)

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are LT-002-158, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if drug LT-002-158 works to treat moderate-to-severe atopic dermatitis in adults.

They plan to enroll about 160 people at Hangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Interventions: LT-002-158, Placebo

Primary outcome (registry wording): Eczema Area and Severity Index (EASI) score

Who it is for (from inclusion criteria)

• Ages 18 Years to 75 Years
• Body mass index (body-mass index (BMI)) \>17.5 kg/m2, and body weight of ≥ 45.0 kg
• A history of atopic dermatitis for at least 6 months prior to the screening visit (meeting the Hanifin-Rajka diagnostic criteria), and:
• EASI score ≥ 16 at the screening and baseline visits;
• vIGA score ≥ 3 at the screening and baseline visits;
• BSA ≥ 10% at the screening and baseline visits;
• A weekly average PP-NRS score of ≥ 4 at baseline (with at least 4 days of evaluation results during the week prior to baseline)
• Participants must apply a stable dose of topical emollients (moisturizer) daily for at least 7 consecutive days immediately prior to the baseline visit, and should be willing to continue using moisturizer throughout the study