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Eosinophilic EsophagitisPhase 3NCT05634746

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

A Phase 3 study testing APT-1011 and Esophagogastroduodenoscopy in people with Eosinophilic Esophagitis, run by Ellodi Pharmaceuticals, LP at 60 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eosinophilic Esophagitis
What is being tested?
APT-1011 and Esophagogastroduodenoscopy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
60 sitesin 2 countries
Study dates
29 Dec 2022to 12 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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)
Show all 27Show fewer
  • 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
  • Subjects who have initiated PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage regimen must remain constant throughout the study
  • Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period
  • Have chronic infection such as prior or active tuberculosis, active chicken pox or measles, or absence of prior measles, mumps, and rubella vaccine. Subjects with tuberculosis exposure or who live in, or travel to, high endemic areas should be assessed locally for tuberculosis before consideration for the study
  • Immunosuppression or immunodeficiency disorder
  • Current malignancy or malignancy within 3 years of Screening, with the exception of skin cancers other than melanoma. Subjects in remission for at least 3 years post-treatment may be enrolled.
  • Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including non-EoE eosinophilic gastrointestinal disorders (EGIDs)
  • Have current drug abuse in the opinion of the Investigator
  • Have current alcohol abuse in the opinion of the Investigator
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
  • Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit
  • Have received an investigational product as part of a clinical trial within 30 days (or 5 half-lives, whichever is longest) of Screening. Subjects who are currently participating in observational studies or enrolled in patient registries are allowed in this study
  • Have participated in a prior study with investigational product APT-1011

Trial locations and contacts

60 sites in 2 countries.

60 sites in 2 countries

United States59 sites

  • New Mexico Clinical Research & Osteoporosis Center, Inc.

    Albuquerque, New Mexico, 87106

  • Washington Gastroenterology, PLLC dba GI Alliance

    Bellevue, Washington, 98004

  • Boston Specialists

    Boston, Massachusetts, 02111

  • Bozeman Health

    Bozeman, Montana, 59715

  • Om Research LLC

    Camarillo, California, 93012

  • UNC Clinical and Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599-7064

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

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

    Chevy Chase, Maryland, 20815

  • Bernstein Clinical Research

    Cincinnati, Ohio, 45236

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Gastro Center of Maryland, LLC

    Columbia, Maryland, 21045

  • Centricity Research Columbus

    Columbus, Ohio, 43213

  • Digestive Health Specialists

    Dothan, Alabama, 36301

  • Deaconess Clinic Allergy

    Evansville, Indiana, 47715

  • GI Alliance - Glenview

    Glenview, Illinois, 60026

  • Carolina Research

    Greenville, North Carolina, 27834

  • GI Alliance - Gurnee

    Gurnee, Illinois, 60031

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Texas Digestive Specialists

    Harlingen, Texas, 78550

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • I.H.S Health, LLC

    Kissimmee, Florida, 34741

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • GI Alliance

    Lubbock, Texas, 79410

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • GI Alliance

    Mansfield, Texas, 76063

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345

  • East View Medical Research LLC

    Mobile, Alabama, 36606

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150

  • New York Gastroenterology Associates

    New York, New York, 10075

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Endoscopic Research Inc

    Orlando, Florida, 32803

  • Revival Clinical Research

    Orlando, Florida, 32807

  • Velocity Clinical Research, Inc.

    Overland Park, Kansas, 66210

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • MNGI Digestive Health, P.A.

    Plymouth, Minnesota, 55446

  • Rapid City Medical Center, LLP

    Rapid City, South Dakota, 57701

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Velocity Clinical Research, Inc.

    Rockville, Maryland, 20854

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • Southern Star Research Institute, LLC.

    San Antonio, Texas, 78229

  • TriWest Research Associates, LLC

    San Diego, California, 92108

  • Precision Research Institute, LLC

    San Diego, California, 92114

  • Advanced Research Institute

    Sandy City, Utah, 84092

  • Premier Allergy Asthma and Immunology

    Scottsdale, Arizona, 85255

  • GI Alliance

    Tacoma, Washington, 98405

  • Clinical Research Institute of Michigan, LLC

    Troy, Michigan, 48098

  • Del Sol Research Management, LLC.

    Tucson, Arizona, 85715

  • Vital Prospects Clinical Research Institute., PC

    Tulsa, Oklahoma, 74136

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401

  • GI Alliance

    Webster, Texas, 77598

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

Other trials in United States

Canada1 site

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario, N8X 2G1

Other trials in Canada

About this study

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 Open-label Extension, in Adult Subjects With Eosinophilic Esophagitis

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.

Read the detailed description

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.

Being tested
APT-1011, Placebo oral tablet, Esophagogastroduodenoscopy
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
Medical subject headings
Eosinophilic Esophagitis, Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APT-1011Drug

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

    Other Names:

    fluticasone propionate

  • Placebo oral tabletDrug

    Placebo orally disintegrating tablet.

    Other Names:

    PBO

  • EsophagogastroduodenoscopyProcedure or surgery

    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

Study groups in NCT05634746
Study groupRoleWhat they receive
APT-1011ExperimentalAPT-1011 3 mg HS
Receives: Drug: APT-1011; Procedure: Esophagogastroduodenoscopy
PlaceboPlacebo comparatorPlacebo HS
Receives: Drug: Placebo oral tablet; Procedure: Esophagogastroduodenoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 24

  2. 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)

    Measured: Week 24

Secondary outcomes (11)

  1. Clinicopathologic Responder Rate

    To compare the percentage of clinicopathologic responders, defined as having complete symptomatic AND histological response at Week 24 (defined as zero dysphagia episodes in the 14 consecutive days prior to Week 24 AND ≤ 6 peak eos/HPF on esophageal mucosal biopsies)

    Measured: Week 24

  2. Percentage of Subjects with ≥70% Reduction in Dysphagia Frequency

    To evaluate the percentage of subjects with ≥70% reduction in dysphagia frequency at Week 24 as compared to baseline (as measured over the 14 consecutive days prior to each visit)

    Measured: Week 24

  3. Mean Change in Dysphagia Frequency

    To compare the mean change from baseline to Week 24 in dysphagia frequency (as measured over the 14 consecutive days prior to each visit)

    Measured: Week 24

  4. Mean Change in PROSE Difficulty Swallowing

    To compare the mean change from baseline to Week 24 in difficulty swallowing using the Patient Reported Outcomes Symptoms of Eosinophilic Esophagitis (PROSE)

    Measured: Week 24

  5. Mean Change in PROSE Pain with Swallowing

    To compare the mean change from baseline to Week 24 in pain with swallowing using the PROSE

    Measured: Week 24

  6. Mean Number of Dysphagia-Free Days

    To compare the mean number of dysphagia-free days from baseline to Week 24

    Measured: Week 24

  7. Percentage of Responders (Strictures and ≥Grade 2 rings)

    To compare the percentage of responders, defined as no longer having strictures and/or ≥Grade 2 rings which were present at baseline, at Week 24

    Measured: Week 24

  8. Percentage of Responders (Strictures)

    To compare the percentage of responders, defined as no longer having strictures which were present at baseline, at Week 24

    Measured: Week 24

  9. Percentage of Responders (≥Grade 2 rings)

    To compare the percentage of responders, defined as no longer having ≥Grade 2 rings which were present at baseline, at Week 24

    Measured: Week 24

  10. Mean Change in EREFs

    To compare endoscopic appearance evaluated by the mean change from baseline to Week 24 in Eosinophilic Esophagitis Endoscopic Reference Score (EREFs)

    Measured: Week 24

  11. Time to First Complete Symptom Response

    Time to first complete symptom response (defined as zero dysphagia episodes in a 14-consecutive-day period)

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start29 Dec 2022
  3. Primary completion12 Aug 2024
  4. Study completion12 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634746
Sponsor's protocol ID
SP-1011-005
Status last verified
Aug 2025
First submitted
22 Nov 2022
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APT-1011 and Esophagogastroduodenoscopy in people with Eosinophilic Esophagitis, run by Ellodi Pharmaceuticals, LP at 60 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histological Remission (Co-Primary Outcome Measure) (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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