Clinical trial NCT05095116: Expanded Access Protocol for Patients With Eosinophilic Esophagitis
Official title: APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Eosinophilic Esophagitis
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
Lead sponsor: Ellodi Pharmaceuticals, LP
Sponsor class: INDUSTRY
First posted: 2021-10-27
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Del Sol Research Management LLC
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Camarillo
country: United States
facility: Ventura County Gastroenterology Medical Group Camarillo
state: California
city: Glendale
country: United States
facility: FOMAT Medical Research
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research Inc
state: Colorado
city: Danbury
country: United States
facility: Nuvance Health Medical Practice Ct, Inc.
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc.
state: Florida
city: Athens
country: United States
facility: Summit Clinical Research
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc.
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Boston Specialists
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan LLC
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: MNGI Digestive Health, P.A.
state: Minnesota
city: Plymouth
country: United States
facility: Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Clinical Research
state: Montana
city: Chapel Hill
country: United States
facility: Clinical and Translational Research Center (CTRC)
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: Cincinnati
country: United States
facility: Gastro Health Research
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Westlake
country: United States
facility: Northshore Gastroenterology Research LLC
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wyomissing
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Medical Center LLP
state: South Dakota
city: Garland
country: United States
facility: GI Alliance
state: Texas
Study officials:
References: