24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-3)
Status:
Not yet recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
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 treatment with
APT-1011.