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Last-Resort treatment opens for rare swallowing disorder

NCT ID NCT05095116

Disease control Sponsor: Ellodi Pharmaceuticals, LP Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program offers APT-1011, a fluticasone tablet that dissolves in the mouth, to patients aged 12 and older with eosinophilic esophagitis who cannot join other studies or have not responded to available treatments. The goal is to provide access until the drug is commercially available. It is an open-label, single-arm program, meaning everyone gets the drug and there is no comparison group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fluticasone propionate orally disintegrating tablet
What this could lead to
If this works, it could provide a treatment option for people with eosinophilic esophagitis who have run out of other choices.
What could go wrong
This is an expanded access program, not a formal trial, so results are not designed to prove effectiveness. It is only for patients who cannot join other studies or have failed other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female ≥12 years of age at the time of informed consent 2. Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents 3. Confirmed medical history of EoE 4. Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options 5. Willing and able to adhere to the treatment regimen and visit schedule Exclusion Criteria: 1. Have known contraindication, hypersensitivity, or intolerance to corticosteroids 2. Have signs and symptoms of adrenal suppression or hypercorticism 3. Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited 4. Have current alcohol or drug abuse in the opinion of the Investigator 5. Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program 6. Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program

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Conditions

The condition(s) this trial relates to.

allergic disease digestive system disorder Eosinophilia eosinophilic esophagitis esophageal disorder esophagitis gastroenteritis hematologic disorder Hypersensitivity, Immediate immune system disorder leukocyte disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis

Contacts and locations

Locations

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117, United States

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Boston Specialists

    Boston, Massachusetts, 02111, United States

  • Bozeman Health Clinical Research

    Bozeman, Montana, 59715, United States

  • Carolina Research

    Greenville, North Carolina, 27834, United States

  • Clinical Research Institute of Michigan LLC

    Chesterfield, Michigan, 48047, United States

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005, United States

  • Clinical and Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599, United States

  • Del Sol Research Management LLC

    Tucson, Arizona, 85715, United States

  • Endoscopic Research, Inc.

    Orlando, Florida, 32803, United States

  • FOMAT Medical Research

    Glendale, California, 91204, United States

  • GI Alliance

    Garland, Texas, 75044, United States

  • Gastro Center of Maryland

    Columbia, Maryland, 21045, United States

  • Gastro Health Research

    Cincinnati, Ohio, 45219, United States

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060, United States

  • Henry Ford Health System

    Novi, Michigan, 48377, United States

  • MGG Group Co., Inc.

    Chevy Chase, Maryland, 20815, United States

  • MNGI Digestive Health, P.A.

    Minneapolis, Minnesota, 55413, United States

  • Medical Associates Research Group

    San Diego, California, 92123, United States

  • Medical Research Center of Connecticut

    Hamden, Connecticut, 06518-3694, United States

  • Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic

    Plymouth, Minnesota, 55446, United States

  • Nature Coast Clinical Research

    Inverness, Florida, 34452, United States

  • Northshore Gastroenterology Research LLC

    Westlake, Ohio, 44145, United States

  • Nuvance Health Medical Practice Ct, Inc.

    Danbury, Connecticut, 06810, United States

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907, United States

  • Rapid City Medical Center LLP

    Rapid City, South Dakota, 57701, United States

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Wyomissing, Pennsylvania, 19610, United States

  • Summit Clinical Research

    Athens, Georgia, 30607, United States

  • United Medical Doctors

    Murrieta, California, 92563, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Ventura County Gastroenterology Medical Group Camarillo

    Camarillo, California, 93012, United States

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136, United States

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519, United States

  • Western States Clinical Research Inc

    Wheat Ridge, Colorado, 80033, United States

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