To evaluate the effect of nemolizumab, a subcutaneously administered humanized monoclonal antibody against interleukin 31 receptor A and concomitant topical medications and oral antihistamines versus placebo on atopic dermatitis (AD)-induced pruritus.

A double-blind, placebo-controlled, parallel group, multicenter phase 3 study population of Japanese adolescents and adults aged ≥13 years (n = 215; median ages: 39 years [nemolizumab] and 40.5 years [placebo]) with a confirmed diagnosis of AD, weight of 30 to 120 kg, inadequate response to medium-potency topical corticosteroids or topical calcineurin inhibitors and oral antihistamines, and elevated visual analog scale (VAS) for pruritus and Eczema Area and Severity Index (EASI) scores.

Patients were randomly assigned in a 2:1 ratio to receive nemolizumab 60 mg subcutaneously (n = 143) versus placebo (n = 72) every 4 weeks, for 16 weeks total. Patients in both groups were allowed to continue the use of topical corticosteroids, calcineurin inhibitors, oral...

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