About this trial
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)
Eligibility criteria
Qualifiers
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%;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- MG-K10 Injection (Humanized Monoclonal Antibody)
- Placebo for MG-K10