The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of HSK44459 in adult participants with Atopic Dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Affiliated Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, China
Percent change from baseline to week 12 in EASI
Evaluate the clinical efficacy of 2 dose levels of HSK44459, compared to placebo, in adult participants with atopic dermatitis (AD) using EASI. A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD
Time frame: From Day 1 (first dose) to Day 85 (week 12)
Proportion of patients with EASI-75 at week 12
Proportion of patients with EASI-75 (≥75% improvement from baseline) at week 12
Time frame: From Day 1 (first dose) to Day 85 (week 12)
Proportion of patients with both IGA 0 to 1and a reduction from baseline of ≥2 points at week 12
The IGA determines severity of AD and clinical response to treatment on a 5-point scale 0 = Clear 1. = Almost clear 2. = Mild 3. = Moderate 4. = Severe
Time frame: From Day 1 (first dose) to Day 85 (week 12)
Proportion of patients with reduction of pruritus WI-NRS ≥3 or WI-NRS ≥4 from baseline to week 12
The WI-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hour period.
Time frame: From Day 1 (first dose) to Day 85 (week 12)
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