This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio.
Study period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks).
After screening is completed, participants will be randomly grouped in a 1:1 ratio. On Day 1 (D1), they will receive a loading dose of either IBI3027 or Dupilumab Injection 600 mg by subcutaneous injection (SC), followed by 300 mg each time, SC administration, once every 2 weeks (Q2W), until the last administration on W44. After the treatment is completed, a 8-week safety follow-up will be conducted.
Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;
Male or female participants aged 18 to 75;
AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;
Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;
Have active skin diseases that may affect the assessment of AD (such as psoriasis or lupus erythematosus), or other skin complications caused by other diseases. Those who are in an acute exacerbation state of AD at the time of randomization (such as participants having rapidly progressing erythroderma or a tendency towards erythroderma, as assessed by the investigators);
Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;
Suspected immunosuppressive disease within 6 months prior to screen;
Within 2 weeks prior to screen, systemic use of antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections) or having superficial skin infections (such as impetigo);