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Expanded Access Protocol for Patients With Eosinophilic Esophagitis | Clinical Trials | Clareo Health

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Expanded Access Protocol for Patients With Eosinophilic Esophagitis

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

NCT05095116•Ellodi Pharmaceuticals, LP

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.

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (35)

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

Key Dates

Last Updated

October 3, 2025

Conditions

Eosinophilic Esophagitis

Interventions

APT-1011 3 mg HS

DRUG

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Prospective Registry of EoSinophilic esOphagitis

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE