Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Last updated: September 29, 2025
Sponsor: Ellodi Pharmaceuticals, LP
Overall Status: Trial Not Available

Phase

N/A

Condition

Gastroenteritis

Allergies & Asthma

Heartburn (Pediatric)

Treatment

APT-1011 3 mg HS

Clinical Study ID

NCT05095116
SP-1011-004
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andparent/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-1011clinical study or have failed available treatment options

  5. Willing and able to adhere to the treatment regimen and visit schedule

Exclusion

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 pregnantwhile participating in the program

  6. Female patients of child-bearing potential who are unable to comply with adequatecontraception use during the program

Study Design

Treatment Group(s): 1
Primary Treatment: APT-1011 3 mg HS
Phase:
Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • Del Sol Research Management LLC

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Del Sol Research Management LLC

    Tucson 5318313, Arizona 5551752 85715
    United States

    Site Not Available

  • Arkansas Gastroenterology

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Arkansas Gastroenterology

    North Little Rock 4124112, Arkansas 4099753 72117
    United States

    Site Not Available

  • Camarillo Endoscopy Center

    Camarillo, California 93012
    United States

    Planned

  • Ventura County Gastroenterology Medical Group Camarillo

    Camarillo, California 93012
    United States

    Site Not Available

  • FOMAT Medical Research

    Glendale, California 91204
    United States

    Site Not Available

  • United Medical Doctors

    Murrieta, California 92563
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego, California 92123
    United States

    Site Not Available

  • Ventura County Gastroenterology Medical Group Camarillo

    Camarillo 5333180, California 5332921 93012
    United States

    Site Not Available

  • FOMAT Medical Research

    Glendale 5352423, California 5332921 91204
    United States

    Site Not Available

  • United Medical Doctors

    Murrieta 5375911, California 5332921 92563
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Western States Clinical Research Inc

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs 5417598, Colorado 5417618 80907
    United States

    Site Not Available

  • Western States Clinical Research Inc

    Wheat Ridge 5443948, Colorado 5417618 80033
    United States

    Site Not Available

  • Nuvance Health Medical Practice Ct, Inc.

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Western Connecticut Health Network

    Danbury, Connecticut 006810
    United States

    Planned

  • Medical Research Center of Connecticut

    Hamden, Connecticut 06518-3694
    United States

    Site Not Available

  • Nuvance Health Medical Practice Ct, Inc.

    Danbury 4832353, Connecticut 4831725 06810
    United States

    Site Not Available

  • Medical Research Center of Connecticut

    Hamden 4835654, Connecticut 4831725 06518-3694
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Site Not Available

  • Endoscopic Research, Inc.

    Orlando, Florida 32803
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness 4159786, Florida 4155751 34452
    United States

    Site Not Available

  • Endoscopic Research, Inc.

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Summit Clinical Research

    Athens, Georgia 30607
    United States

    Site Not Available

  • Summit Clinical Research

    Athens 4180386, Georgia 4197000 30607
    United States

    Site Not Available

  • Riley Children's Hospital at Indiana University Health

    Peoria, Illinois 61637
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • MGG Group Co., Inc.

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Gastro Center of Maryland

    Columbia, Maryland 21045
    United States

    Site Not Available

  • MGG Group Co., Inc.

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Site Not Available

  • Gastro Center of Maryland

    Columbia 4352053, Maryland 4361885 21045
    United States

    Site Not Available

  • Boston Specialists

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Boston Specialists

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Clinical Research Institute of Michigan LLC

    Chesterfield, Michigan 48047
    United States

    Planned

  • Henry Ford Health System

    Novi, Michigan 48377
    United States

    Site Not Available

  • Henry Ford Medical Center

    Novi, Michigan 48377
    United States

    Planned

  • West Michigan Clinical Research Center

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Clinical Research Institute of Michigan LLC

    Chesterfield 4988681, Michigan 5001836 48047
    United States

    Site Not Available

  • Henry Ford Health System

    Novi 5004062, Michigan 5001836 48377
    United States

    Site Not Available

  • West Michigan Clinical Research Center

    Wyoming 5015618, Michigan 5001836 49519
    United States

    Site Not Available

  • MNGI Digestive Health, P.A.

    Minneapolis, Minnesota 55413
    United States

    Site Not Available

  • Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • MNGI Digestive Health, P.A.

    Minneapolis 5037649, Minnesota 5037779 55413
    United States

    Site Not Available

  • Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic

    Plymouth 5041926, Minnesota 5037779 55446
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield 4381072, Missouri 4398678 63005
    United States

    Site Not Available

  • Bozeman Health Clinical Research

    Bozeman, Montana 59715
    United States

    Site Not Available

  • Bozeman Health Clinical Research

    Bozeman 5641727, Montana 5667009 59715
    United States

    Site Not Available

  • Clinical and Translational Research Center (CTRC)

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Planned

  • Carolina Research

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Clinical and Translational Research Center (CTRC)

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Carolina Research

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Gastro Health Research

    Cincinnati, Ohio 45219
    United States

    Planned

  • Great Lakes Gastroenterology

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Northshore Gastroenterology Research LLC

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Site Not Available

  • Gastro Health Research

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Great Lakes Gastroenterology

    Mentor 5162645, Ohio 5165418 44060
    United States

    Site Not Available

  • Northshore Gastroenterology Research LLC

    Westlake 5176517, Ohio 5165418 44145
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Planned

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Digestive Disease Associates LTD

    Wyomissing, Pennsylvania 19610
    United States

    Planned

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Site Not Available

  • Rapid City Medical Center LLP

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Rapid City Medical Center LLP

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • GI Alliance

    Garland, Texas 75044
    United States

    Site Not Available

  • Digestive Health Associates of Texas-Rockwall

    Richardson, Texas 75082
    United States

    Site Not Available

  • GI Alliance

    Garland 4693003, Texas 4736286 75044
    United States

    Site Not Available

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