Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Stapokibatrt in Children With Moderate-to-severe Atopic Dermatitis

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.

Inclusion Criteria:

• Age ≥ 2 and ≤ 11 years old.
• Diagnosis of AD according to the American Academy of Dermatology Consensus (2014) Criteria.
• With moderate-to-severe AD, and inadequate response to topical medications.

Exclusion Criteria:

• Prior treatment with Stapokibart
• Treatment with dupilumab within 13 weeks prior to the baseline visit, or treatment with anti-IgE(Immunoglobulin E) monoclonal antibody，other biological agents within 5 half-lives prior to the baseline visit .
• Treatment with immunosuppressants/immunomodulatory drugs, ultraviolet therapy, or systemic traditional Chinese medicine for AD within 4 weeks prior to the baseline visit.
• Treatment with a topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or topical Phosphodiesterase-4(PDE-4) inhibitor within 1 weeks prior to the baseline visit.
• History of atopic keratoconjunctivitis invading cornea.
• Acute attacks of Atopic Dermatitis within 4 weeks prior to the baseline visit.
• Planned major surgical procedure during the patient's participation in this study.