Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)
Status:
Completed
Trial end date:
2019-10-23
Target enrollment:
Participant gender:
Summary
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by
eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting
corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and
pathological features of EoE.
APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This
study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with
EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance
treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.