A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.

Inclusion Criteria:

• Male or female subjects aged ≥12<18 years old, weight ≥ 30kg.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
• Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.

Exclusion Criteria:

• Acute onset of AD in 4 weeks prior to enrollment.
• Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
• Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
• Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
• Received treatment with other clinical study drugs within 4 weeks or 5 halflives before randomization (whichever is longer).
• Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.