Regeneron, Sanofi Present Phase 3 Trial For Dupixent (Dupilumab) In Children Aged 1 To 11 Years With Eosinophilic Esophagitis
Regeneron, Sanofi Present Phase 3 Trial For Dupixent (Dupilumab) In Children Aged 1 To 11 Years With Eosinophilic Esophagitis
The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16.
試驗顯示，接受按體重分層給予更高劑量的Dupixent的患者在16周時的許多關鍵疾病指標方面顯著改善，相比安慰劑。
These data showed weight-tiered higher dose dupilumab significantly improved key eosinophilic esophagitis histologic, endoscopic and cellular measures in children as young as 1 year old with sustained results for up to one year.
這些數據顯示，按體重分層給予更高劑量的dupilumab明顯改善了兒童中的關鍵嗜酸性食管炎組織學、內窺鏡和細胞學指標，結果持續一年。
The trial is ongoing with a 108-week open-label extension period (Part C) to evaluate longer-term outcomes. The primary endpoint was histologic remission at 16 weeks, and secondary endpoints included assessments of endoscopic and histopathologic measures of the severity of disease along with clinical signs and symptoms of EoE.
試驗正在進行中，有一個持續108周的開放標籤延長期（C部分），以評估更長期的結果。主要終點是16周處於組織學緩解狀態，次要終點包括評估疾病嚴重程度的內窺鏡和組織病理學指標以及EoE的臨床體徵和症狀。
Safety results were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE.
安全性結果與已知的EoE青少年和成年人Dupixent的安全性配置一致。
譯文內容由第三人軟體翻譯。