BackgroundEsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO‐101) is under investigation for the treatment of eosinophilic oesophagitis (EoE).AimsTo evaluate the efficacy, safety and tolerability of ESO‐101 in patients with active EoE.MethodsWe conducted a randomised, placebo‐controlled, phase 2, proof‐of‐concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (n = 15), or EsoCap loaded with 800 μg of mometasone furoate (n = 28) once daily during 28 days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures.ResultsTreatment with ESO‐101 resulted in reduction (mean ± SD) of 49.1 ± 88.4 eosinophils/high‐power field from baseline, compared with 6.6 ± 65.1 with placebo (p = 0.03). With ESO‐101, 48% and 44% of patients achieved < 15 and < 6 eosinophils/high‐power field, respectively; these were 0% with placebo. EoE Endoscopic Reference Score reduced significantly in patients treated with ESO‐101. In contrast, dysphagia and odynophagia severity decreased similarly in both groups. There were no serious treatment‐emergent adverse events. Mean serum cortisol did not change significantly throughout the trial. Notably, no oropharyngeal or oesophageal candidiasis was documented. The device was well tolerated.ConclusionsESO‐101 was superior to placebo in reducing oesophageal eosinophilia. The device was safe and well tolerated in adults with EoE, supporting the continued development of ESO‐101 for the treatment of EoE (Trials.gov No.: NCT04849390; Eu‐CT No.: 2020–000082‐16).

中文翻译：

---

临床试验：局部皮质类固醇的新型食管输送系统与安慰剂治疗嗜酸性粒细胞性食管炎的安全性和有效性


背景EsoCap 是一种薄的粘膜粘附膜，旨在靶向食管粘膜。装有糠酸莫米松 （ESO-101） 的装置正在研究中用于治疗嗜酸性粒细胞性食管炎 （EoE）。目的评价 ESO-101 在活动性 EoE 患者中的疗效、安全性和耐受性。方法我们在 14 个欧洲地点对成人 EoO 进行了随机、安慰剂对照、2 期、概念验证试验。参与者在 28 天内每天一次接受安慰剂、未包衣的 EsoCap （n = 15） 或加载 800 μg 糠酸莫米松 （n = 28） 的 EsoCap。主要结局是嗜酸性粒细胞峰值计数的绝对变化;次要结局是组织学、临床和内窥镜检查。结果用 ESO-101 治疗导致嗜酸性粒细胞/高倍视野较基线减少 49.1 ± 88.4 个嗜酸性粒细胞/高倍视野 （平均 ± SD），而安慰剂组分别为 6.6 ± 65.1 （p = 0.03）。使用 ESO-101,48% 和 44% 的患者分别达到 < 15 和 < 6 嗜酸性粒细胞/高倍视野;安慰剂组为 0%。接受 ESO-101 治疗的患者的 EoE 内窥镜参考评分显着降低。相比之下，两组的吞咽困难和吞咽严重程度的下降相似。没有严重的治疗中出现的不良事件。在整个试验过程中，平均血清皮质醇没有显著变化。值得注意的是，没有口咽或食管念珠菌病的记录。该设备耐受性良好。结论ESO-101 在减少食管嗜酸性粒细胞增多方面优于安慰剂。该设备在成人 EoO 患者中安全且耐受性良好，支持 ESO-101 治疗 EoO 的持续开发（Trials.gov 编号：NCT04849390;Eu-CT 编号：2020–000082‐16）。