A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis
This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.
• Able to understand and sign the informed consent form (ICF);
• Aged ≥ 18 years, male or female;
• Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
• EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;
• Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.