NCT05083312

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

An Adolescent Sub-study Within FLUTE-2: A Randomized, Double-blind, Placebo-Controlled Study of APT-1011 (Fluticasone Propionate Oral Dispersible Tablet Formulation), With an Open-label Extension, in Adolescent Subjects With Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ellodi Pharmaceuticals, LP · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 that will evaluate the efficacy and safety of APT-1011 3 mg administered HS for the induction of response to treatment (histologic and symptomatic) over 12 weeks. At Week 12, subjects may move into the open-label single arm study of APT-1011 3 mg hora somni (HS; at bedtime). All subjects who do not move into the open-label study will return at Week 14 for a 2-week off-treatment follow-up.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	APT-1011	APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
DRUG	Placebo oral tablet	Placebo orally disintegrating tablet

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-09-05
• Completion: 2022-09-05
• First posted: 2021-10-19
• Last updated: 2023-09-21

Locations

3 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study