Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Ellodi Pharmaceuticals

Status

Conditions: Eosinophilic Esophagitis

Treatments: Drug: APT-1011 3 mg HS

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05095116

SP-1011-004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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