This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)
Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months;
Eczema Area and Severity Index (EASI) ≥16;
Investigator's Global Assessment (IGA) ≥3;
Body Surface Area (BSA) involvement ≥10%;
Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;
Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;
Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;
Concurrent serious diseases including, but not limited to, cardiovascular, metabolic, or neurological diseases, which, in the opinion of the investigator, render the subject unsuitable for immunosuppressive therapy;
Parallel
MG-K10 Injection (Humanized Monoclonal Antibody)
Drugloading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
Placebo for MG-K10
DrugInitial loading dose (SC), then single dose Q2W through Week 52
Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline )
Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline
Change in Peak Pruritus NRS
Proportion of participants achieving EASI-50, EASI-90
Change and percent change from baseline in the Quality of Life Score: CDLQI and EQ-5D-Y-3L scores
Incidence in adverse events
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