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Secondary efficacy assessments included Investigator's Global Assessment (<jats:styled-content style=\"fixed-case\">IGA<\/jats:styled-content>) and patient\u2010reported outcome (<jats:styled-content style=\"fixed-case\">PRO<\/jats:styled-content>) pruritus assessments (Pruritus Categorical Response Scale [<jats:styled-content style=\"fixed-case\">PCRS<\/jats:styled-content>], Pruritus Numeric Rating Scales [<jats:styled-content style=\"fixed-case\">PNRS<\/jats:styled-content>], Pruritus Interference Numeric Rating Scale [<jats:styled-content style=\"fixed-case\">PINRS<\/jats:styled-content>] and Subject's Global Impressions of Change in Pruritus [<jats:styled-content style=\"fixed-case\">SGICP<\/jats:styled-content>]). Eighty\u2010eight of 105 planned patients were randomized before the study was stopped and unblinded for safety reasons. The study did not meet the primary end\u2010point. However, numerical improvements (i.e. decreases) in median<jats:styled-content style=\"fixed-case\">EASI<\/jats:styled-content>were observed with<jats:styled-content style=\"fixed-case\">JNJ<\/jats:styled-content>\u201039758979 100\u00a0mg (\u22123.7) and 300\u00a0mg (\u22123.0) versus placebo (\u22121.3) at week 6. Nominally significant improvements across<jats:styled-content style=\"fixed-case\">PRO PCRS<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\">PNRS<\/jats:styled-content>and<jats:styled-content style=\"fixed-case\">SGICP<\/jats:styled-content>assessments were consistently observed, particularly with<jats:styled-content style=\"fixed-case\">JNJ<\/jats:styled-content>\u201039758979 300\u00a0mg. Safety, including adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>), was comparable between<jats:styled-content style=\"fixed-case\">JNJ<\/jats:styled-content>\u201039758979 and placebo with the exception of two patients (both receiving<jats:styled-content style=\"fixed-case\">JNJ<\/jats:styled-content>\u201039758979 300\u00a0mg) with serious<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>of neutropenia, leading to premature study discontinuation. No deaths were reported. Except for neutropenia, no clinically relevant changes in laboratory values were observed. Although not conclusive, findings suggest H<jats:sub>4<\/jats:sub>R\u2010antagonism may be beneficial for<jats:styled-content style=\"fixed-case\">AD<\/jats:styled-content>, particularly in controlling pruritus.<jats:styled-content style=\"fixed-case\">JNJ<\/jats:styled-content>\u201039758979 appears to be associated with drug\u2010induced agranulocytosis, likely an off\u2010target effect.<\/jats:p>","DOI":"10.1111\/1346-8138.12726","type":"journal-article","created":{"date-parts":[[2014,12,10]],"date-time":"2014-12-10T05:09:14Z","timestamp":1418188154000},"page":"129-139","source":"Crossref","is-referenced-by-count":123,"title":["Phase 2a, randomized, double\u2010blind, placebo\u2010controlled, multicenter, parallel\u2010group study of a H<sub>4<\/sub>R\u2010antagonist (<scp>JNJ<\/scp>\u201039758979) in<scp>J<\/scp>apanese adults with moderate atopic 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