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.

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (35)

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

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