drugset / Trial / NCT05083312

Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial

NCT05083312

Phase 3 Completed 6 enrolled Ellodi Pharmaceuticals, LP
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to \<18 years) with EoE.

Timeline

Start
2021-09-30
Primary completion
2022-09-05
Completion
2022-09-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 3 mg Oral