Clinical trialNCT05634746CompletedPhase 3Interventional

24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)

SponsorEllodi Pharmaceuticals, LPEnrollment218Eosinophilic Esophagitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Evan Dellon, MD, MPH
UNC Center for Esophageal Diseases and Swallowing
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

60 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Joel Liem Medicine Professional Corporation
Windsor, Ontario, Canada

United States

Digestive Health Specialists
Dothan, Alabama, United States
East View Medical Research Llc
Mobile, Alabama, United States
Premier Allergy Asthma and Immunology
Scottsdale, Arizona, United States
del Sol Research Management, Llc.
Tucson, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Om Research Llc
Camarillo, California, United States
Providence Facey Medical Foundation
Mission Hills, California, United States
United Medical Doctors
Murrieta, California, United States
Precision Research Institute, Llc
San Diego, California, United States
Triwest Research Associates, Llc
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
Medical Research Center of Connecticut, Llc
Hamden, Connecticut, United States
Nature Coast Clinical Research
Inverness, Florida, United States
I.H.S Health, Llc
Kissimmee, Florida, United States
Endoscopic Research Inc
Orlando, Florida, United States
Revival Clinical Research
Orlando, Florida, United States
Gastroenterology Associates of Central Georgia, Llc
Macon, Georgia, United States
Gi Alliance - Glenview
Glenview, Illinois, United States
Gi Alliance - Gurnee
Gurnee, Illinois, United States
Deaconess Clinic Allergy
Evansville, Indiana, United States
Gastroenterology Health Partners, Pllc
New Albany, Indiana, United States
Velocity Clinical Research, Inc.
Overland Park, Kansas, United States
Mgg Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Gastro Center of Maryland, Llc
Columbia, Maryland, United States
Velocity Clinical Research, Inc.
Rockville, Maryland, United States
Boston Specialists
Boston, Massachusetts, United States
Clinical Research Institute of Michigan, Llc
Chesterfield, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
Clinical Research Institute of Michigan, Llc
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, United States
Mngi Digestive Health, P.A.
Plymouth, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Bozeman Health
Bozeman, Montana, United States
Advanced Research Institute
Reno, Nevada, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
New York Gastroenterology Associates
New York, New York, United States
Unc Clinical and Translational Research Center (ctrc)
Chapel Hill, North Carolina, United States

20 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

APT-1011Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Dec 2022
Primary completion: 12 Aug 2024
Completion: 12 Aug 2024
Last update posted: 13 Aug 2025
Registered enrollment: 218
Registry id: NCT05634746

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.