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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
520
The 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
The 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
Southern Medical University Dermatology Hospital Medicine
Guangzhou, Guangdong, China
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.
Time frame: Week 16
The proportion of participants who reached EASI-75
Time frame: Week 24&Week 52
The proportion of participants who reached EASI-50
Time frame: Week16、Week24、Week52
The proportion of participants who achieved EASI-90
Time frame: Week16、Week24、Week52
The change in the EASI score compared to the baseline
Time frame: Week16、Week24、Week52
The overall assessment by the researchers - the proportion of participants who achieved treatment success (IGA-TS, with an IGA score of 0 or 1 and a reduction of ≥ 2 points from the baseline)
The Investigator's Global Assessment Scale for Atopic Dermatitis (IGA) is a 5-point classification scale based on the overall appearance of skin lesions at a specific time point (0 = cleared; 1 = largely cleared; 2 = mild; 3 = moderate; 4 = severe). It is evaluated by the researchers.
Time frame: Week16、Week24、Week52
Percentage change in the body surface area affected (BSA) from the baseline
Time frame: Week16、Week24、Week52
The proportion of participants whose weekly average score on the Peak Pruritus Numerical Rating Scale (PP-NRS) decreased by ≥ 3 points compared to the baseline
The Pruritus Numerical Rating Scale (PP-NRS) is used to allow participants to report the severity of their pruritus over the past 24 hours. The most severe pruritus is represented by a single-item NRS, with a score range of 0 to 10. Participants are required to use the scale to evaluate the intensity of their most severe pruritus, with 10 representing the highest level of pruritus.
Time frame: Week2、Week16、Week24、Week52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.