A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis

Inclusion criteria

• Able to understand the study and voluntarily sign the ICF.
• Atopic dermatitis (AD) diagnosed at least 6 months before screening.
• Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.
• A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.
• Inadequate response or intolerance to prior topical therapy for AD.
• The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.

Exclusion criteria

• Acute onset of AD within the first 4 weeks of randomization.
• Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.
• Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
• Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.
• Received allergen specific immunotherapy within the 12 weeks before randomization.
• Have a history of allergies to any component of AK139 and/or severe allergic reactions to monoclonal antibodies.