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First received: November 22, 2022

Clinical Trial: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3)

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Eosinophilic Esophagitis

Study Type: INTERVENTIONAL


Official Title: Fluticasone Propionate Oral Disintegrating Tablet Formulation in Eosinophilic Esophagitis: a Randomized, Double-blind, Placebo-Controlled 24-Week Induction Study of APT-1011, Followed by a Single-arm

Brief Summary: This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (?18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension.This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks.The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label…

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