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);
Parallel
Dupilumab Injection
DrugThe participants in Dupilumab injection treatment group will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44
IBI3027
DrugThe participants in IBI3027 treatment group will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44
The proportion of participants who achieved EASI-75
EASI is an assessment tool used to evaluate the severity of atopic dermatitis and the extent of skin lesions involved. The score of EASI ranges from 0 to 72 points. The higher the score, the more severe the disease. EASI divides the affected areas into four regions: head and neck, trunk, upper limbs, and lower limbs. Scores are given for each region based on the area of involvement. The severity of skin lesions in each region is calculated according to the severity of erythema, sclerosis or papules, epidermal desquamation, and lichenification. Finally, the scores of the four regions are added together to obtain the total score.
The proportion of participants who reached EASI-75
The proportion of participants who reached EASI-50
The proportion of participants who achieved EASI-90
The change in the EASI score compared to the baseline
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