智通财经APP讯，英硅智能(03696)发布公告，英硅智能自主研发的Rentosertib(ISM001-055) 正式启动III期临床试验(CTR20262475，NCT07687459)，相关信息已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)官方注册平台公示，并于 ClinicalTrials.gov网站登记。
该项前瞻性、随机、双盲、安慰剂对照、平行组III期研究计划评估Rentosertib每日一次、连续用药52周的有效性及安全性，预计于全国47个研究中心招募共320 名受试者。
研究方案设有试验药组及对照药组，将向随机分配至各组的受试者给予 Rentosertib或安慰剂片剂，并以52周内用力肺活量(FVC)年下降率作为主要终点，同时综合纳入首次疾病进展时间、肺一氧化碳弥散量(DLCO)变化，以及基于问卷量度的生活质素等多维度指标作为次要终点。
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