Expanded Access Protocol for Patients With Eosinophilic Esophagitis
NCT ID: NCT05095116
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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APT-1011 3 mg HS
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Ellodi Pharmaceuticals, LP
INDUSTRY
Responsible Party
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Locations
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Del Sol Research Management LLC
Tucson, Arizona, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Ventura County Gastroenterology Medical Group Camarillo
Camarillo, California, United States
FOMAT Medical Research
Glendale, California, United States
United Medical Doctors
Murrieta, California, United States
Medical Associates Research Group
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Western States Clinical Research Inc
Wheat Ridge, Colorado, United States
Nuvance Health Medical Practice Ct, Inc.
Danbury, Connecticut, United States
Medical Research Center of Connecticut
Hamden, Connecticut, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Endoscopic Research, Inc.
Orlando, Florida, United States
Summit Clinical Research
Athens, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
MGG Group Co., Inc.
Chevy Chase, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Boston Specialists
Boston, Massachusetts, United States
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
MNGI Digestive Health, P.A.
Minneapolis, Minnesota, United States
Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
Plymouth, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Bozeman Health Clinical Research
Bozeman, Montana, United States
Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
Carolina Research
Greenville, North Carolina, United States
Gastro Health Research
Cincinnati, Ohio, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Northshore Gastroenterology Research LLC
Westlake, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Wyomissing, Pennsylvania, United States
Rapid City Medical Center LLP
Rapid City, South Dakota, United States
GI Alliance
Garland, Texas, United States
Countries
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Other Identifiers
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SP-1011-004
Identifier Type: -
Identifier Source: org_study_id
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