This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)
Time frame: Baseline to Week 16
Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.
Time frame: Baseline to Week 16
Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16
Time frame: Baseline to Week 16
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