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.
AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year
The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment
The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation
The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD
Patients with eye diseases that the researchers judged as unsuitable for inclusion
Patients with malignant tumors within 5 years
There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received
Parallel
MG-K10 placebo
Biological/VaccineAdminister the drug once every 4 weeks for a total of 6 times
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
The percentage of subjects reaching EASI-75 at 24 weeks of treatment
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;
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