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

NCT05634746 | Completed Phase 3 FDA Drug

• 1 other identifier: SP-1011-005
• Study Type: interventional
• Target: 218
• Locations: 2 countries
• Sites: 60

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.

Conditions

Eosinophilic Esophagitis

Keywords

APT-1011; Esophagitis; Eosinophilic Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; FLUTE 3; FLUTE III; Flute

Outcome Measures

Primary Outcomes (2)

• Histological Remission (Co-Primary Outcome Measure)

  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

  Week 24

• Complete Symptomatic Response (Co-Primary Outcome Measure)

  To evaluate the percentage of subjects with complete symptomatic response at Week 24 (defined as zero dysphagia episodes in the 14 consecutive days prior to Week 24)

  Week 24

Secondary Outcomes (11)

• Clinicopathologic Responder Rate

  Week 24

• Percentage of Subjects with ≥70% Reduction in Dysphagia Frequency

  Week 24

• Mean Change in Dysphagia Frequency

  Week 24

• Mean Change in PROSE Difficulty Swallowing

  Week 24

• Mean Change in PROSE Pain with Swallowing

  Week 24

Study Arms (2)

APT-1011

EXPERIMENTAL

APT-1011 3 mg HS

Drug: APT-1011; Procedure: Esophagogastroduodenoscopy

Placebo

PLACEBO COMPARATOR

Placebo HS

Drug: Placebo oral tablet; Procedure: Esophagogastroduodenoscopy

Interventions

APT-1011 DRUG

APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient. Other Names: fluticasone propionate

APT-1011

Placebo oral tablet DRUG

Placebo orally disintegrating tablet. Other Names: PBO

Placebo

Esophagogastroduodenoscopy PROCEDURE

Esophagogastroduodenoscopy (EGD) is a test that involves an endoscope, a lighted camera on the end of a tube, that is passed down a subject's throat to visualize their esophagus

APT-1011; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female ≥18 years of age at the time of informed consent
• Each subject must read, understand, and provide consent on the ICF for this study and be willing and able to adhere to study-related treatment regimens, procedures, and visit schedule
• Diagnosis or presumptive diagnosis of EoE that is confirmed during the Screening period by histology that demonstrates ≥15 peak eos/HPF. In order to ensure that a diagnosis can be made, at least 6 biopsies should be taken in total from both proximal and distal esophageal mucosal areas (at least 3 each). Mid-esophageal biopsies are not required (optional). 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.
• Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period
• Biopsies will be read by a central pathologist
• Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
• Optional biopsies may be taken and processed locally for local use, only where specified in the local ICF. If serious pathology is unexpectedly encountered biopsies of such lesions must be processed locally
• Have a subject-reported history of ≥6 episodes to a maximum of 30 episodes of dysphagia in a 14-consecutive-day period within 18 days prior to baseline
• Completion of the evening eDiary on at least 11 out of the 14-consecutive-day observation period during the 4-week run-in period (Baseline Symptom Assessment).The minimum requirement of 11 days need not be consecutive.

You may not qualify if:

• Have known contraindication, hypersensitivity, or intolerance to corticosteroids
• Have a contraindication to, or factors that substantially increase the risk of, EGD procedure or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard (8-10 mm) endoscope
• Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
• Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator's judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study or increase the safety risk to the subject such as uncontrolled diabetes or hypertension
• History of recurrent or current oral or esophageal mucosal infection due to inhaled or nasal corticosteroids
• Have any mouth or dental condition that prevents normal eating (excluding braces)
• Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE, including erosive esophagitis (grade B or higher as per the Los Angeles Classification of Gastroesophageal Reflux Disease; hiatus hernia longer than 3 cm, Barrett's esophagus, and achalasia)
• Use of systemic (oral or parenteral) corticosteroids within 30 days before Screening, use of swallowed corticosteroids within 30 days before Screening
• Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
• Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
• Use of potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ritonavir and ketoconazole) in the 4 weeks before Screening
• Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
• Abnormal ACTH stimulation defined as a serum cortisol level \<16 μg/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 μg cosyntropin
• Use of biologic immunomodulators, including dupilumab for EoE, with dose last administered within 6 months before Screening (allergy desensitization injection or oral therapies allowed as long as the course of therapy is not altered during the study period)
• Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2 receptor antagonists, antacids or antihistamines, leukotriene inhibitors, or sodium cromolyn within 4 weeks before qualifying endoscopy during Screening. If already receiving these drugs, the dosage must remain constant throughout the study

Sponsors & Collaborators

• Ellodi Pharmaceuticals, LP: lead

Study Sites (60)

Digestive Health Specialists

Dothan, Alabama, 36301, United States

Location

East View Medical Research LLC

Mobile, Alabama, 36606, United States

Location

Premier Allergy Asthma and Immunology

Scottsdale, Arizona, 85255, United States

Location

Del Sol Research Management, LLC.

Tucson, Arizona, 85715, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Om Research LLC

Camarillo, California, 93012, United States

Location

Providence Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

United Medical Doctors

Murrieta, California, 92563, United States

Location

TriWest Research Associates, LLC

San Diego, California, 92108, United States

Location

Precision Research Institute, LLC

San Diego, California, 92114, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

I.H.S Health, LLC

Kissimmee, Florida, 34741, United States

Location

Endoscopic Research Inc

Orlando, Florida, 32803, United States

Location

Revival Clinical Research

Orlando, Florida, 32807, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201, United States

Location

GI Alliance - Glenview

Glenview, Illinois, 60026, United States

Location

GI Alliance - Gurnee

Gurnee, Illinois, 60031, United States

Location

Deaconess Clinic Allergy

Evansville, Indiana, 47715, United States

Location

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150, United States

Location

Velocity Clinical Research, Inc.

Overland Park, Kansas, 66210, United States

Location

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Gastro Center of Maryland, LLC

Columbia, Maryland, 21045, United States

Location

Velocity Clinical Research, Inc.

Rockville, Maryland, 20854, United States

Location

Boston Specialists

Boston, Massachusetts, 02111, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Clinical Research Institute of Michigan, LLC

Troy, Michigan, 48098, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

MNGI Digestive Health, P.A.

Plymouth, Minnesota, 55446, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Bozeman Health

Bozeman, Montana, 59715, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

New Mexico Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

New York Gastroenterology Associates

New York, New York, 10075, United States

Location

UNC Clinical and Translational Research Center (CTRC)

Chapel Hill, North Carolina, 27599-7064, United States

Location

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Carolina Research

Greenville, North Carolina, 27834, United States

Location

Bernstein Clinical Research

Cincinnati, Ohio, 45236, United States

Location

Centricity Research Columbus

Columbus, Ohio, 43213, United States

Location

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145, United States

Location

Vital Prospects Clinical Research Institute., PC

Tulsa, Oklahoma, 74136, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States

Location

Rapid City Medical Center, LLP

Rapid City, South Dakota, 57701, United States

Location

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

Location

GI Alliance

Lubbock, Texas, 79410, United States

Location

GI Alliance

Mansfield, Texas, 76063, United States

Location

Southern Star Research Institute, LLC.

San Antonio, Texas, 78229, United States

Location

GI Alliance

Webster, Texas, 77598, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Advanced Research Institute

Sandy City, Utah, 84092, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Washington Gastroenterology, PLLC dba GI Alliance

Bellevue, Washington, 98004, United States

Location

GI Alliance

Tacoma, Washington, 98405, United States

Location

Joel Liem Medicine Professional Corporation

Windsor, Ontario, N8X 2G1, Canada

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Interventions

APT-1011; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Evan Dellon, MD, MPH

  UNC Center for Esophageal Diseases and Swallowing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: December 29, 2022
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (59); CA (1)