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Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05095116
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ellodi Pharmaceuticals, LP
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Available
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Del Sol Research Management LLC, Tucson, Arizona

Status

Available

Address

Del Sol Research Management LLC

Tucson, Arizona, 85712

Arkansas Gastroenterology, North Little Rock, Arkansas

Status

Available

Address

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117

Camarillo Endoscopy Center, Camarillo, California

Status

Available

Address

Camarillo Endoscopy Center

Camarillo, California, 93012

FOMAT Medical Research, Glendale, California

Status

Available

Address

FOMAT Medical Research

Glendale, California, 91204

United Medical Doctors, Murrieta, California

Status

Available

Address

United Medical Doctors

Murrieta, California, 92563

Medical Associates Research Group, San Diego, California

Status

Available

Address

Medical Associates Research Group

San Diego, California, 92123-4207

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Available

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907

Western States Clinical Research Inc, Wheat Ridge, Colorado

Status

Available

Address

Western States Clinical Research Inc

Wheat Ridge, Colorado, 80033

Western Connecticut Health Network, Danbury, Connecticut

Status

Available

Address

Western Connecticut Health Network

Danbury, Connecticut, 006810

Medical Research Center of Connecticut, Hamden, Connecticut

Status

Available

Address

Medical Research Center of Connecticut

Hamden, Connecticut, 06518-3694

Nature Coast Clinical Research, Inverness, Florida

Status

Available

Address

Nature Coast Clinical Research

Inverness, Florida, 34452

Endoscopic Research, Inc., Orlando, Florida

Status

Available

Address

Endoscopic Research, Inc.

Orlando, Florida, 32803

Summit Clinical Research, Athens, Georgia

Status

Available

Address

Summit Clinical Research

Athens, Georgia, 30607

Peoria, Illinois

Status

Available

Address

Riley Children's Hospital at Indiana University Health

Peoria, Illinois, 61637

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Available

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

MGG Group Co., Inc., Chevy Chase, Maryland

Status

Available

Address

MGG Group Co., Inc.

Chevy Chase, Maryland, 20815

Gastro Center of Maryland, Columbia, Maryland

Status

Available

Address

Gastro Center of Maryland

Columbia, Maryland, 21045-5274

Boston Specialists, Boston, Massachusetts

Status

Available

Address

Boston Specialists

Boston, Massachusetts, 02111

Chesterfield, Michigan

Status

Available

Address

Clinical Research Institute of Michigan LLC

Chesterfield, Michigan, 48047

Henry Ford Medical Center, Novi, Michigan

Status

Available

Address

Henry Ford Medical Center

Novi, Michigan, 48377

West Michigan Clinical Research Center, Wyoming, Michigan

Status

Available

Address

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

MNGI Digestive Health, P.A., Minneapolis, Minnesota

Status

Available

Address

MNGI Digestive Health, P.A.

Minneapolis, Minnesota, 55413

Plymouth, Minnesota

Status

Available

Address

Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic

Plymouth, Minnesota, 55446

Clinical Research Professionals, Chesterfield, Missouri

Status

Available

Address

Clinical Research Professionals

Chesterfield, Missouri, 63005

Bozeman Health Clinical Research, Bozeman, Montana

Status

Available

Address

Bozeman Health Clinical Research

Bozeman, Montana, 59718

Chapel Hill, North Carolina

Status

Available

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Carolina Research, Greenville, North Carolina

Status

Available

Address

Carolina Research

Greenville, North Carolina, 27834

Bernstein Clinical Research Center, LLC, Cincinnati, Ohio

Status

Available

Address

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231-4927

Great Lakes Gastroenterology, Mentor, Ohio

Status

Available

Address

Great Lakes Gastroenterology

Mentor, Ohio, 44060

Northshore Gastroenterology Research LLC, Westlake, Ohio

Status

Available

Address

Northshore Gastroenterology Research LLC

Westlake, Ohio, 44145

Tulsa, Oklahoma

Status

Available

Address

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136

Philadelphia, Pennsylvania

Status

Available

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Digestive Disease Associates LTD, Wyomissing, Pennsylvania

Status

Available

Address

Digestive Disease Associates LTD

Wyomissing, Pennsylvania, 19610

Rapid City Medical Center LLP, Rapid City, South Dakota

Status

Available

Address

Rapid City Medical Center LLP

Rapid City, South Dakota, 57701

Richardson, Texas

Status

Available

Address

Digestive Health Associates of Texas-Rockwall

Richardson, Texas, 75082

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