Expanded Access Protocol for Patients With Eosinophilic Esophagitis

NO_LONGER_AVAILABLE

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT05095116

Run by

Ellodi Pharmaceuticals, LP

Last updated by the study team

2025-10-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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