伊斯卡利马布在新发型1型糖尿病的青少年和年轻成年人的2期 (2a) 随机试验
Chantal Mathieu1, Michelle Quinlan2, Kristina Wagner3
1UZ Leuven, Leuven, Belgium.
Diabetes technology & therapeutics
|November 28, 2025
概括
伊斯卡利马布是一种抗CD40抗体,在新发型1型糖尿病 (T1DM) 患者中,β细胞功能下降速度较慢. 虽然它没有达到初级疗效终点,但它表明了可接受的安全性概况,以便进一步调查.
科学领域:
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 1型糖尿病 (T1DM) 涉及胰腺β细胞的自身免疫破坏.
- CD40-CD154通路在免疫激活和自身免疫性中起作用.
- 向CD40可能会调节T1DM中的免疫反应.
研究的目的:
- 为了评估iscalimab的安全性和有效性,一个单克隆抗CD40抗体,在新发病的第3阶段T1DM.
- 评估伊斯卡利马布对β细胞功能和血糖控制的影响.
- 研究伊斯卡利马布在T1DM中的免疫调节作用.
主要方法:
- 第二阶段 (2a) 随机化,安慰剂控制的研究.
- 参与者接受了伊斯卡利马布或安慰剂静脉注射,随后进行皮下注射1年.
- 评估了安全性,β细胞功能 (C-AUC) 和血糖控制 (HbA1c).
主要成果:
- 在52周的C-AUC没有显著差异 (P=0.18).
- 伊斯卡利马布显示,正常化刺激CAUC (P=0.04) 的下降趋势较慢.
- 在第52周使用伊斯卡利马布与安慰剂时,HbA1c的较低几何平均比率;观察到淋巴细胞计数发生变化.
- 通常是安全的,耐受性很好,可控的不良事件.
结论:
- 伊斯卡利马布在新发病的T1DM中表现出可接受的安全性和耐受性.
- 效率结果受到样本大小的限制,但表明保留β细胞功能的潜力.
- CD40:CD154抑制需要进一步研究T1DM治疗策略.
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