This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
To ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses.
To ensure blinding,an additional 2 mL of placebo will be administered subcutaneously at Weeks 4, 8, 12, 16 and 20.
Tower 5,No.34,Chunxiao Road No.122 Pudong District, Shanghai, 201203.p R. china
Shanghai, Shanghai Municipality, China
Hangzhou First People's Hospital
Zhejiang, 杭州, China
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
Time frame: 24 weeks
The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment
The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline;
Time frame: 24 weeks
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