Expanded Access Protocol for Patients With Eosinophilic Esophagitis

September 29, 2025 updated by: Ellodi Pharmaceuticals, LP

APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis

This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management LLC
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Camarillo, California, United States, 93012
        • Ventura County Gastroenterology Medical Group Camarillo
      • Glendale, California, United States, 91204
        • Fomat Medical Research
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research Inc
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Nuvance Health Medical Practice Ct, Inc.
      • Hamden, Connecticut, United States, 06518-3694
        • Medical Research Center of Connecticut
    • Florida
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc.
    • Georgia
      • Athens, Georgia, United States, 30607
        • Summit Clinical Research
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co., Inc.
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Boston Specialists
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan LLC
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • West Michigan Clinical Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • MNGI Digestive Health, P.A.
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
    • Montana
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Clinical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Clinical and Translational Research Center (CTRC)
      • Greenville, North Carolina, United States, 27834
        • Carolina Research
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Bernstein Clinical Research Center, LLC
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology
      • Westlake, Ohio, United States, 44145
        • Northshore Gastroenterology Research LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Regional Gastroenterology Associates of Lancaster, Ltd.
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center LLP
    • Texas
      • Garland, Texas, United States, 75044
        • GI Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ellodi Pharmaceuticals, LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-1011-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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