This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)
Placebo of matching volume,Subcutaneous injection(SC)
Beijing Children's Hospital Capital Medical University
Beijing, China
Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18
The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).
Time frame: Up to week 18
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