强生(JNJ.US)口服IL-23R拮抗剂两项III期研究获得积极关键结果

智通财经
19 Nov 2024

智通财经APP获悉,11月18日,强生(JNJ.US)宣布口服IL-23R拮抗剂Icotrokinra(JNJ-2113)治疗斑块状银屑病(PsO)的III期ICONIC-LEAD研究获得了积极的关键结果。这是第一款成功完成III期研究的口服IL-23R靶向药物。

ICONIC-LEAD研究是一项全球性、多中心、随机、双盲、安慰剂对照临床试验(n=684,其中66例为青少年),评估了Icotrokinra对比安慰剂治疗患有中度至重度斑块状银屑病的12岁及以上青少年和成人患者的安全性和有效性。在该研究中,Icotrokinra的安全性数据与既往在II期研究(FRONTIER 1和FRONTIER 2研究)中观察到的结果一致。Icotrokinra组和安慰剂组发生不良事件(AE)的患者比例相似,分别有49.3%和49.1%的患者在第16周出现治疗期间不良事件(TEAE)。

此外,Icotrokinra治疗特殊部位(头皮、生殖器和/或手掌和脚掌)斑块状银屑病的III期ICONIC-TOTAL研究也取得了积极的结果。结果显示,治疗第16周,Icotrokinra组实现IGA 0/1的患者比例高于安慰剂组。强生表示,这两项研究的详细数据将在近期举行的医学会议上公布,并计划将其提交至监管机构。

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