Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Last updated: January 11, 2024
Sponsor: Ellodi Pharmaceuticals, LP
Overall Status: Planned

Phase

N/A

Condition

Esophageal Disorders

Heartburn

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 pregnant whileparticipating 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

    Planned

  • Arkansas Gastroenterology

    North Little Rock, Arkansas 72117
    United States

    Planned

  • Camarillo Endoscopy Center

    Camarillo, California 93012
    United States

    Planned

  • Ventura County Gastroenterology Medical Group Camarillo

    Camarillo, California 93012
    United States

    Planned

  • FOMAT Medical Research

    Glendale, California 91204
    United States

    Planned

  • United Medical Doctors

    Murrieta, California 92563
    United States

    Planned

  • Medical Associates Research Group

    San Diego, California 92123
    United States

    Planned

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Planned

  • Western States Clinical Research Inc

    Wheat Ridge, Colorado 80033
    United States

    Planned

  • Nuvance Health Medical Practice Ct, Inc.

    Danbury, Connecticut 06810
    United States

    Planned

  • Western Connecticut Health Network

    Danbury, Connecticut 006810
    United States

    Planned

  • Medical Research Center of Connecticut

    Hamden, Connecticut 06518-3694
    United States

    Planned

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Planned

  • Endoscopic Research, Inc.

    Orlando, Florida 32803
    United States

    Planned

  • Summit Clinical Research

    Athens, Georgia 30607
    United States

    Planned

  • 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

    Planned

  • MGG Group Co., Inc.

    Chevy Chase, Maryland 20815
    United States

    Planned

  • Gastro Center of Maryland

    Columbia, Maryland 21045
    United States

    Planned

  • Boston Specialists

    Boston, Massachusetts 02111
    United States

    Planned

  • Clinical Research Institute of Michigan LLC

    Chesterfield, Michigan 48047
    United States

    Planned

  • Henry Ford Health System

    Novi, Michigan 48377
    United States

    Planned

  • Henry Ford Medical Center

    Novi, Michigan 48377
    United States

    Planned

  • West Michigan Clinical Research Center

    Wyoming, Michigan 49519
    United States

    Planned

  • MNGI Digestive Health, P.A.

    Minneapolis, Minnesota 55413
    United States

    Planned

  • Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic

    Plymouth, Minnesota 55446
    United States

    Planned

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Planned

  • Bozeman Health Clinical Research

    Bozeman, Montana 59715
    United States

    Planned

  • Clinical and Translational Research Center (CTRC)

    Chapel Hill, North Carolina 27599
    United States

    Planned

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Planned

  • Carolina Research

    Greenville, North Carolina 27834
    United States

    Planned

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Planned

  • Gastro Health Research

    Cincinnati, Ohio 45219
    United States

    Planned

  • Great Lakes Gastroenterology

    Mentor, Ohio 44060
    United States

    Planned

  • Northshore Gastroenterology Research LLC

    Westlake, Ohio 44145
    United States

    Planned

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Planned

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Planned

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Planned

  • Digestive Disease Associates LTD

    Wyomissing, Pennsylvania 19610
    United States

    Planned

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Wyomissing, Pennsylvania 19610
    United States

    Planned

  • Rapid City Medical Center LLP

    Rapid City, South Dakota 57701
    United States

    Planned

  • GI Alliance

    Garland, Texas 75044
    United States

    Planned

  • Digestive Health Associates of Texas-Rockwall

    Richardson, Texas 75082
    United States

    Site Not Available

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