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 5318313, Arizona 5551752, United States
Arkansas Gastroenterology
North Little Rock 4124112, Arkansas 4099753, United States
Ventura County Gastroenterology Medical Group Camarillo
Camarillo 5333180, California 5332921, United States
FOMAT Medical Research
Glendale 5352423, California 5332921, United States
United Medical Doctors
Murrieta 5375911, California 5332921, United States
Medical Associates Research Group
San Diego 5391811, California 5332921, United States
Peak Gastroenterology Associates
Colorado Springs 5417598, Colorado 5417618, United States
Western States Clinical Research Inc
Wheat Ridge 5443948, Colorado 5417618, United States
Nuvance Health Medical Practice Ct, Inc.
Danbury 4832353, Connecticut 4831725, United States
Medical Research Center of Connecticut
Hamden 4835654, Connecticut 4831725, United States
Nature Coast Clinical Research
Inverness 4159786, Florida 4155751, United States
Endoscopic Research, Inc.
Orlando 4167147, Florida 4155751, United States
Summit Clinical Research
Athens 4180386, Georgia 4197000, United States
University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182, United States
MGG Group Co., Inc.
Chevy Chase 4351335, Maryland 4361885, United States
Gastro Center of Maryland
Columbia 4352053, Maryland 4361885, United States
Boston Specialists
Boston 4930956, Massachusetts 6254926, United States
Clinical Research Institute of Michigan LLC
Chesterfield 4988681, Michigan 5001836, United States
Henry Ford Health System
Novi 5004062, Michigan 5001836, United States
West Michigan Clinical Research Center
Wyoming 5015618, Michigan 5001836, United States
MNGI Digestive Health, P.A.
Minneapolis 5037649, Minnesota 5037779, United States
Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
Plymouth 5041926, Minnesota 5037779, United States
Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678, United States
Bozeman Health Clinical Research
Bozeman 5641727, Montana 5667009, United States
Clinical and Translational Research Center (CTRC)
Chapel Hill 4460162, North Carolina 4482348, United States
Carolina Research
Greenville 4469160, North Carolina 4482348, United States
Gastro Health Research
Cincinnati 4508722, Ohio 5165418, United States
Bernstein Clinical Research Center, LLC
Cincinnati 4508722, Ohio 5165418, United States
Great Lakes Gastroenterology
Mentor 5162645, Ohio 5165418, United States
Northshore Gastroenterology Research LLC
Westlake 5176517, Ohio 5165418, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa 4553433, Oklahoma 4544379, United States
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Wyomissing 5220248, Pennsylvania 6254927, United States
Rapid City Medical Center LLP
Rapid City 5768233, South Dakota 5769223, United States
GI Alliance
Garland 4693003, Texas 4736286, 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