Expanded Access Protocol for Patients With Eosinophilic Esophagitis

This is an expanded access trial for Eosinophilic Esophagitis focused on measuring 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 Read More

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