成年牛皮患者的cedirogant:一个II期,随机的,安慰剂控制的临床试验
Stephen Tyring1, Angela Moore2,3, Akimchi Morita4
1Center for Clinical Studies, Department of Dermatology, McGovern School of Medicine, University of Texas Health Science Center, Houston, TX, USA.
Clinical and experimental dermatology
|May 3, 2024
概括
赛迪罗甘特通过改善银病区域和严重性指数 (PASI) 评分,显示出治疗银病的潜力. 然而,由于临床前发现,该研究被提前终止,并且已经停止了cedirogant的开发.
科学领域:
- 免疫学 免疫学 免疫学
- 皮肤病学 皮肤病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 干白素 (IL) - 17/IL-23信号传递与牛皮有关.
- 基剂向ROR-玛异型2 (RORyt),这是IL-17产生的一个关键因素.
研究的目的:
- 评估cedirogant对中度至重度牛皮的疗效和安全性.
- 评估cedirogant对牛皮区域和严重性指数 (PASI) 评分和其他牛皮症状的影响.
主要方法:
- 第IIb期,多中心,双盲,随机对照试验.
- 156名成年患者接受了口服cedirogant (75毫克,150毫克,375毫克) 或安慰剂,每天服用一次,持续16周.
- 主要终点:PASI 75成就;次要终点包括静态医生的全球评估和牛皮症状尺度.
主要成果:
- 16周的PASI 75率为29% (75毫克),8% (150毫克) 和42% (375毫克),与安慰剂组的0%相比.
- 低剂量cedirogant和安慰剂的不良事件发生率相似,但375毫克剂量更高.
- 该研究因临床前发现而提前结束.
结论:
- 赛迪罗甘特在改善皮病患者的PASI分数方面表现出有效性.
- 在测试剂量下,该药物一般耐受良好.
- 在早期结束研究后,停止了cedirogant的开发.
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