This trial was designed to evaluate the efficacy and safety of SHR-1819 in adult patients with moderate-to-severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
SHR-1819 injection.
SHR-1819 injection blank preparation.
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
The proportion of participants who achieved EASI-75 (≥75% decrease in the score on the Eczema Area and Severity Index (EASI) from the baseline).
Eczema Area and Severity Index score using the Eczema Area and Severity Index scale.
Time frame: Week 24.
The proportion of participants with a baseline daily Itch Numeric Rating Scale (I-NRS) score of ≤4 per week.
The Itch Numeric Rating Scale score using the Itch Numeric Rating Scale.
Time frame: Week 24.
Adverse events (AEs).
Time frame: About 42 weeks.
The concentration of SHR-1819 in serum.
Time frame: From week -16 to week -8, about every 4 weeks; From week 0 to week 32, about every 8 weeks.
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