A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis

The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.

Key Inclusion Criteria

• Male or female participants ≥ 12 to < 17 years of age
• Chronic AD that has been documented for at least 2 years
• Eczema Area and Severity Index (EASI) score ≥ 16
• Investigator's Global Assessment (IGA) score ≥ 3
• AD involvement ≥ 10% of Body Surface Area (BSA)
• Documented recent history of inadequate response to topical medications
• Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria

• Body weight < 30 kilogram (kg)
• Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody)
• Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment