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Phase 2a, randomized, double‐blind, placebo‐controlled, multicenter, parallel‐group study of a H 4 R‐antagonist ( JNJ ‐39758979) in J apanese adults with moderate atopic dermatitis
Author(s) -
Murata Yoko,
Song Michael,
Kikuchi Hisayuki,
Hisamichi Katsuya,
Xu Xie L.,
Greenspan Andrew,
Kato Mai,
Chiou ChiunFang,
Kato Takeshi,
Guzzo Cynthia,
Thurmond Robin L.,
Ohtsuki Mamitaro,
Furue Masutaka
Publication year - 2015
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.12726
Subject(s) - placebo , discontinuation , medicine , eczema area and severity index , adverse effect , randomized controlled trial , clinical endpoint , atopic dermatitis , antagonist , neutropenia , gastroenterology , physical therapy , toxicity , dermatology , alternative medicine , receptor , pathology
This trial was conducted to evaluate the safety and efficacy of the H 4 R‐antagonist JNJ ‐39758979 in adult Japanese patients with moderate atopic dermatitis ( AD ). Eligible patients were randomly assigned to JNJ ‐39758979 300 mg, 100 mg or placebo once daily for 6 weeks in this phase 2a, double‐blind, multicenter, placebo‐controlled study. Primary efficacy was assessed via week‐6 Eczema Area and Severity Index ( EASI ) scores. Secondary efficacy assessments included Investigator's Global Assessment ( IGA ) and patient‐reported outcome ( PRO ) pruritus assessments (Pruritus Categorical Response Scale [ PCRS ], Pruritus Numeric Rating Scales [ PNRS ], Pruritus Interference Numeric Rating Scale [ PINRS ] and Subject's Global Impressions of Change in Pruritus [ SGICP ]). Eighty‐eight of 105 planned patients were randomized before the study was stopped and unblinded for safety reasons. The study did not meet the primary end‐point. However, numerical improvements (i.e. decreases) in median EASI were observed with JNJ ‐39758979 100 mg (−3.7) and 300 mg (−3.0) versus placebo (−1.3) at week 6. Nominally significant improvements across PRO PCRS , PNRS and SGICP assessments were consistently observed, particularly with JNJ ‐39758979 300 mg. Safety, including adverse events ( AE ), was comparable between JNJ ‐39758979 and placebo with the exception of two patients (both receiving JNJ ‐39758979 300 mg) with serious AE 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 4 R‐antagonism may be beneficial for AD , particularly in controlling pruritus. JNJ ‐39758979 appears to be associated with drug‐induced agranulocytosis, likely an off‐target effect.