At a glance
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FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis
In Brief
A Phase 2 clinical trial evaluating APT-1011 and Placebo for Eosinophilic Esophagitis. Completed, enrolled 106 participants across 75 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.