This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.
Both males and females, aged 18 to 65 years (inclusive) on the day of signing the informed consent;
Diagnosed with Atopic dermatitis according to the American Academy of Dermatology consensus criteria (2014) and with a history of disease for at least 6 months prior to signing the informed consent;
At the screening and baseline visits, the severity of Atopic dermatitis is classified as moderate to severe, that is, the following 4 conditions are met simultaneously; Eczema Area and Severity Index (EASI) score ≥ 16 points; Investigator's Global Assessment (IGA) score ≥ 3 points; Percent Body Surface Area (BSA) ≥10%; Weekly mean of daily Peak Pruritus Numerical Rating Scale (NRS) score ≥ 4 points;
Application of a stable dose of basic, mild, inactive ingredient-free topical emollients (moisturizers) twice daily for at least 7 consecutive days before the first dose and throughout the study.
Previous treatment with biological agents for Atopic dermatitis (e.g., dupilumab, tralokinumab), XKH001, or drugs with the same target (including investigational products);
Allergen-specific immunization therapy for Atopic dermatitis within 6 months prior to the first dose;
Ultraviolet for Atopic dermatitis (including but not limited to narrow-band ultraviolet B (NB-UVB) and medium-to-high dose UVA1) within 4 weeks prior to the first dose;
Treatment with prescription emollients or emollients containing active ingedients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products) initiated during the screening period (if such emollients are used prior to signing the informed consent, they can be continued at a stable dose);