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

No longer available

Conditions

Intervention / Treatment

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

Expanded Access

Expanded Access Type

  • 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 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

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

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

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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