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Incyte的JAK1/JAK2抑制剂ruxolitinib乳膏治疗特应性皮炎的第二个III期临床成功

2020-02-20 不详 MedSci原创

Incyte报道其JAK1 / JAK2抑制剂ruxolitinib的局部乳膏剂达到了轻度至中度特应性皮炎的青少年和成人患者III期TRuE-AD1试验的主要终点和次要终点。ruxolitinib的局部乳膏剂在III期TRuE-AD2研究中也达到了主要终点。

Incyte的JAK1/JAK2抑制剂ruxolitinib的局部乳膏剂达到了轻度至中度特应性皮炎的青少年和成人患者III期TRuE-AD1试验的主要终点和次要终点。ruxolitinib的局部乳膏剂在III期TRuE-AD2研究中也达到了主要终点。

该公司炎症和自身免疫部门负责人Jim Lee评论说:"两项研究的成功结果都证实了ruxolitinib乳膏作为非甾体药物,具有治疗数百万异位性皮炎患者的潜力。我们期待与监管机构合作,寻求批准ruxolitinib乳膏作为JAK抑制剂的首个局部用药制剂。"

TRuE-AD1纳入了622名12岁及以上的患者,他们被诊断出患有特应性皮炎至少两年。患者被随机分配接受ruxolitinib乳膏每天两次。

在TRuE-AD1中,接受低剂量ruxolitinib乳膏的患者中有50%达到了IGA-TS,接受高剂量的患者中有53.8%达到了IGA-TS,相比之下,对照组的患者为15.1%。此外,低剂量和高剂量ruxolitinib乳膏组的患者中,分别有56%和62.1%的患者达到了EASI75,而对照组为24.6%。

原始出处:


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    2020-07-24 juliusluan78
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  5. 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    2020-06-04 jklm09
  6. 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  7. 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    2020-02-22 zhouqu_8
  8. 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    2020-02-22 gao_jian4220
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Incyte宣布一项重要的3期GRAVITAS-301研究结果,该研究评估了itacitinib联合皮质类固醇在未接受过治疗的急性移植物抗宿主病(GVHD)患者中疗效。与安慰剂联合皮质类固醇相比,伊西替尼联合皮质类固醇在第28天未达到改善总缓解率(ORR)的主要终点(分别为74.0%和66.4%,p = 0.08)。

FDA将优先审查Incyte的FGFR抑制剂pemigatinib以治疗胆管癌

Incyte近日宣布,FDA将优先审查pemigatinib的市场应用,以作为某些胆管癌患者的潜在疗法。 Incyte靶向治疗负责人Peter Langmuir表示:“一线化疗以外的治疗选择有限,如果pemigatinib获得批准,选择性FGFR抑制剂将成为二线治疗的首选治疗方法”。

Incyte以11亿美元收购MorphoSys的抗CD19单抗tafasitamab,用于治疗B细胞淋巴瘤

Incyte已与MorphoSys签署了一项价值高达11亿美元的协议,以共同开发和商业化MorphoSys的淋巴瘤候选药物抗CD19单抗tafasitamab。

礼来和Incyte宣布其口服JAK抑制剂Baricitinib在中度至重度特应性皮炎患者中进行的3期临床研究BREEZE-AD5的阳性结果

礼来和Incyte宣布,其口服选择性JAK抑制剂baricitinib达到了BREEZE-AD5的主要研究终点。该研究为3期临床、随机安慰剂对照,用于评估Baricitinib治疗成人中重度特应性皮炎(AD)患者安全性和有效性的研究。主要终点指标定义为第16周时,湿疹面积和严重程度指数(EASI)与基线相比至少达到75%或更高比例。

Incyte宣布开展Ruxolitinib的III期临床试验

Incyte制药公司近日宣布,III期TRuE-AD临床试验已经招募了第1名患者,以评估ruxolitinib作为青少年和成人患者(年龄≥12岁)单药治疗特应性皮炎(AD)的长期安全性和有效性。

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