Eosinophilic Esophagitis
Conditions
Keywords
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
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.
Interventions
DRUGAPT-1011 3 mg HS
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Sponsors
Ellodi Pharmaceuticals, LP
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Countries
United States
Outcome results
None listed