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.
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.
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
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
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
Vered Katz Ben-Yair, M.Sc, B.A.
1-833-435-8833
ClinicalTrials@ellodipharma.com
David Strunk
(615) 804-2452
david.strunk@ellodipharma.com