FLUTE研究评估了APT-1011(丙酸氟替卡松口腔崩解片)vs安慰剂治疗EoE的安全性和有效性。 方法:在这项随机、双盲、安慰剂对照、剂量探索、2b期研究中,106例EoE成人接受了4种APT-1011剂量方案中的1种或安慰剂,为期12周诱导期和40周维持期。主要结局指标是组织学应答(≤6个嗜酸性粒细胞每高倍视野)。次要结局指标包...
APT-1011Eosinophilic EsophagitisFluticasone Propionate? 2022 The AuthorsBackground & Aims: Topical steroids are effective treatments for eosinophilic esophagitis (EoE). The FLUTE (Fluticasone in EoE) trial evaluated safety and efficacy of APT-1011 (fluticasone propionate oral disintegrating tablet) vs ...
“The FDA’s decision to grant APT-1011 Fast Track designation is an important milestone that underscores the strong unmet medical need to develop safe and effective therapies for EoE,” said Dr. Gina Eagle, Vice President and Head of R&D. “We are encouraged by the results of our clinical ...
S0345Safety and Efficacy of Long-Term Treatment of EoE With Fluticasone Propionate Orally Disintegrating Tablet (APT-1011): Results From 40 Weeks Treatment in a Phase 2b Randomized Double-Blind Placebo-Controlled Trialdoi:10.14309/01.ajg.0000703428.23468.41Dellon, Evan S....