Expanded Access Protocol for Patients With Eosinophilic Esophagitis
APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
1 other identifier
expanded_access
N/A
1 country
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
35 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedOctober 3, 2025
September 1, 2025
October 14, 2021
September 29, 2025
Conditions
Keywords
Interventions
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Eligibility Criteria
You may qualify if:
- Male or female ≥12 years of age at the time of informed consent
- Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
- Confirmed medical history of EoE
- Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
- Willing and able to adhere to the treatment regimen and visit schedule
You may not qualify if:
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- Have signs and symptoms of adrenal suppression or hypercorticism
- Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- Have current alcohol or drug abuse in the opinion of the Investigator
- Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
- Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Del Sol Research Management LLC
Tucson, Arizona, 85715, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Ventura County Gastroenterology Medical Group Camarillo
Camarillo, California, 93012, United States
FOMAT Medical Research
Glendale, California, 91204, United States
United Medical Doctors
Murrieta, California, 92563, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Western States Clinical Research Inc
Wheat Ridge, Colorado, 80033, United States
Nuvance Health Medical Practice Ct, Inc.
Danbury, Connecticut, 06810, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518-3694, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Endoscopic Research, Inc.
Orlando, Florida, 32803, United States
Summit Clinical Research
Athens, Georgia, 30607, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
MGG Group Co., Inc.
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Boston Specialists
Boston, Massachusetts, 02111, United States
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, 48047, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
MNGI Digestive Health, P.A.
Minneapolis, Minnesota, 55413, United States
Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
Plymouth, Minnesota, 55446, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Bozeman Health Clinical Research
Bozeman, Montana, 59715, United States
Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599, United States
Carolina Research
Greenville, North Carolina, 27834, United States
Gastro Health Research
Cincinnati, Ohio, 45219, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236, United States
Great Lakes Gastroenterology
Mentor, Ohio, 44060, United States
Northshore Gastroenterology Research LLC
Westlake, Ohio, 44145, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Wyomissing, Pennsylvania, 19610, United States
Rapid City Medical Center LLP
Rapid City, South Dakota, 57701, United States
GI Alliance
Garland, Texas, 75044, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2021
First Posted
October 27, 2021
Last Updated
October 3, 2025
Record last verified: 2025-09