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

Study Status: COMPLETED
Recruit Status: COMPLETED
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 treatment with APT-1011.

Detailed Summary:

The efficacy and safety of APT-1011 3 mg administered at bedtime will be evaluated for the induction of response (histologic and symptomatic) after 24 weeks of treatment.
After completing 24 weeks of double-blind study treatment, subjects may consent to participate in the open-label extension, otherwise they will complete study drug treatment and enter a 2-week off treatment safety follow-up.

The duration of the double-blind portion of the study, screening through follow-up visit for subjects completing study drug at Week 24, will be up to 32 weeks long, i.e., 6-week screening period (the includes a 4-week run-in phase) followed by 24 weeks induction phase and 2 weeks off-treatment follow-up.
For subjects consenting to participate in the open-label extension, the duration of the study will be determined by the Sponsor.

Sponsor: Ellodi Pharmaceuticals, LP

Current Primary Outcome: To evaluate the percentage of subjects with histological remission (defined ? 6 peak eosinophils [eos]/high power field [HPF] on esophageal mucosal biopsies at Week 24).
HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens (0.3 mm^2) and 22 mm ocular

Original Primary Outcome: To evaluate the percentage of subjects with histological remission (defined ? 6 peak eosinophils [eos]/high power field [HPF] on esophageal mucosal biopsies at Week 24).
HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens (0.3 mm^2) and 22 mm ocular

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ellodi Pharmaceuticals, LP

Dates:
Date Received: November 22, 2022
Date Started: December 29, 2022
Date Completion: August 12, 2024
Last Updated: September 18, 2024
Last Verified: September 01, 2024