Expanded Access Protocol for Patients With Eosinophilic Esophagitis
- Conditions
- Eosinophilic Esophagitis
- Registration Number
- NCT05095116
- Lead Sponsor
- Ellodi Pharmaceuticals, LP
- Brief 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.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Male or female ≥12 years of age at the time of informed consent
- Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
- Confirmed medical history of EoE
- Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
- Willing and able to adhere to the treatment regimen and visit schedule
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- Have signs and symptoms of adrenal suppression or hypercorticism
- Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- Have current alcohol or drug abuse in the opinion of the Investigator
- Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
- Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Boston Specialists
🇺🇸Boston, Massachusetts, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Gastro Health Research
🇺🇸Cincinnati, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Del Sol Research Management LLC
🇺🇸Tucson, Arizona, United States
FOMAT Medical Research
🇺🇸Glendale, California, United States
United Medical Doctors
🇺🇸Murrieta, California, United States
Ventura County Gastroenterology Medical Group Camarillo
🇺🇸Camarillo, California, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, 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
Clinical Research Institute of Michigan LLC
🇺🇸Chesterfield, Michigan, United States
MGG Group Co., Inc.
🇺🇸Chevy Chase, Maryland, United States
Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
🇺🇸Plymouth, Minnesota, United States
Bozeman Health Clinical Research
🇺🇸Bozeman, Montana, United States
West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
MNGI Digestive Health, P.A.
🇺🇸Minneapolis, Minnesota, United States
Clinical and Translational Research Center (CTRC)
🇺🇸Chapel Hill, North Carolina, United States
Carolina Research
🇺🇸Greenville, North Carolina, United States
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States
Northshore Gastroenterology Research LLC
🇺🇸Westlake, Ohio, 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