中国抗体-B(03681):SM17在中国治疗中重度特异性皮炎的 1B期临床试验的积极顶线结果

智通财经
07 Apr

智通财经APP讯,中国抗体-B(03681)发布公告,

SM17在中国治疗特异性皮炎的1B期临床试验的积极顶线结果,尤其在抗瘙痒效果方面展现了差异化疗效。

本项1b期临床研究是一项随机双盲、多中心、安慰剂对照入组临床试验,旨在研究SM17的用药安全性、耐受性及药代动力学特征,并初步验证SM17对于中重度 AD患者的有效性。1b期研究共纳入32例中重度AD患者,按3:3:2的比例随机接受高剂量SM17(600mg)、低剂量SM17(200mg)或安慰剂治疗,试验周期包括12周的治疗期及随后4周的停药维持╱安全随访期。本次试验的主要终点为SM17的安全性性质,评估内容为16周期间的耐受性、治疗引致不良事件(TEAE)发生率、生命体征及实验室检查指标的变化。

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