Official Title
APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
Brief Summary

This expanded access program is an open-label, single-arm design where consentingpatients may participate up until APT-1011 is commercially available in the relevantregions 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.

Available
Intermediate-size Population
Eosinophilic Esophagitis

Drug: APT-1011 3 mg HS

APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its
active ingredient.
Other Name: fluticasone propionate

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
United States
Locations

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

Contacts

Vered Katz Ben-Yair, M.Sc, B.A.
1-833-435-8833
ClinicalTrials@ellodipharma.com

David Strunk
(615) 804-2452
david.strunk@ellodipharma.com

Ellodi Pharmaceuticals, LP
NCT Number
Keywords
APT-1011
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents
MeSH Terms
Esophagitis
Eosinophilic Esophagitis
Fluticasone
Xhance