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首页> 外文期刊>The Journal of dermatology >Phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of a H4R-antagonist (JNJ-39758979) in Japanese adults with moderate atopic dermatitis
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Phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of a H4R-antagonist (JNJ-39758979) in Japanese adults with moderate atopic dermatitis

机译：2a期，随机，双盲，安慰剂对照，多中心，平行组研究H4R拮抗剂（JNJ-39758979）在中度特应性皮炎的日本成年人中

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This trial was conducted to evaluate the safety and efficacy of the H4R-antagonist JNJ-39758979 in adult Japanese patients with moderate atopic dermatitis (AD). Eligible patients were randomly assigned to JNJ-39758979 300mg, 100mg or placebo once daily for 6weeks 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 100mg (-3.7) and 300mg (-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 300mg. Safety, including adverse events (AE), was comparable between JNJ-39758979 and placebo with the exception of two patients (both receiving JNJ-39758979 300mg) 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 H4R-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.
机译：进行该试验以评估H4R拮抗剂JNJ-39758979在成年日本中度特应性皮炎（AD）患者中的安全性和有效性。在2a期双盲，多中心，安慰剂对照研究中，将符合条件的患者随机分配给JNJ-39758979 300mg，100mg或安慰剂，连续6周，每天一次，共6周。通过第6周的湿疹面积和严重程度指数（EASI）评分评估主要疗效。次要功效评估包括研究者的整体评估（IGA）和患者报告的结局（PRO）瘙痒评估（Pruritus分类反应量表[PCRS]，瘙痒数字评分量表[PNRS]，瘙痒干扰数字评分量表[PINRS]和受试者对药物的整体印象瘙痒的变化[SGICP]）。为安全起见，在105名计划中的患者中有88名被随机分配，然后停止研究并取消盲目治疗。该研究不符合主要终点。但是，在第6周时，与安慰剂（-1.3）相比，JNJ-39758979 100mg（-3.7）和300mg（-3.0）和安慰剂（-1.3）观察到了EASI中位数的数值改善（即降低）。一致观察到，特别是与300mg JNJ-39758979在JNJ-39758979和安慰剂之间，包括不良事件（AE）在内的安全性相当，只有两名中性粒细胞减少症严重AE的患者（均接受JNJ-39758979 300 mg），导致研究提前终止。没有死亡的报道。除嗜中性白血球减少症外，未观察到实验室值的临床相关变化。尽管不是结论性的，但研究结果表明H4R拮抗作用可能对AD有益，特别是在控制瘙痒症方面。 JNJ-39758979似乎与药物诱导的粒细胞缺乏症有关，可能是脱靶效应。

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