A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
Trial Parameters
Brief Summary
The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study. 2. Age between 18 and 75 years old (inclusive). 3. Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive). 4. Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion. 5. At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months. 6. At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥4. 7. History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical