Eosinophilic EsophagitisNCT05095116
Expanded Access Protocol for Patients With Eosinophilic Esophagitis
A study testing APT-1011 3 mg HS in people with Eosinophilic Esophagitis, run by Ellodi Pharmaceuticals, LP at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- APT-1011 3 mg HS
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 35 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Male or female ≥12 years of age at the time of informed consent
- Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
- Confirmed medical history of EoE
- Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
- Willing and able to adhere to the treatment regimen and visit schedule
Who cannot join
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- Have signs and symptoms of adrenal suppression or hypercorticism
- Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- Have current alcohol or drug abuse in the opinion of the Investigator
- Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
- Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Summit Clinical Research
Athens, Georgia, 30607
Boston Specialists
Boston, Massachusetts, 02111
Bozeman Health Clinical Research
Bozeman, Montana, 59715
Ventura County Gastroenterology Medical Group Camarillo
Camarillo, California, 93012
Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, 48047
Clinical Research Professionals
Chesterfield, Missouri, 63005
MGG Group Co., Inc.
Chevy Chase, Maryland, 20815
Gastro Health Research
Cincinnati, Ohio, 45219
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Gastro Center of Maryland
Columbia, Maryland, 21045
Nuvance Health Medical Practice Ct, Inc.
Danbury, Connecticut, 06810
GI Alliance
Garland, Texas, 75044
FOMAT Medical Research
Glendale, California, 91204
Carolina Research
Greenville, North Carolina, 27834
Medical Research Center of Connecticut
Hamden, Connecticut, 06518-3694
Nature Coast Clinical Research
Inverness, Florida, 34452
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Great Lakes Gastroenterology
Mentor, Ohio, 44060
MNGI Digestive Health, P.A.
Minneapolis, Minnesota, 55413
United Medical Doctors
Murrieta, California, 92563
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Henry Ford Health System
Novi, Michigan, 48377
Endoscopic Research, Inc.
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic
Plymouth, Minnesota, 55446
Rapid City Medical Center LLP
Rapid City, South Dakota, 57701
Medical Associates Research Group
San Diego, California, 92123
Del Sol Research Management LLC
Tucson, Arizona, 85715
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Northshore Gastroenterology Research LLC
Westlake, Ohio, 44145
Western States Clinical Research Inc
Wheat Ridge, Colorado, 80033
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
Regional Gastroenterology Associates of Lancaster, Ltd.
Wyomissing, Pennsylvania, 19610
About this study
Official title: APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
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.
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- APT-1011 3 mg HS
- 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
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APT-1011 3 mg HSDrug
Also called fluticasone propionate
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Ellodi Pharmaceuticals, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095116
- Sponsor's protocol ID
- SP-1011-004
- Status last verified
- Sep 2025
- First submitted
- 14 Oct 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT05095116
- Acronym / sponsor ID
- SP-1011-004
- Conditions
- Eosinophilic Esophagitis
- Keywords
- APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Ellodi Pharmaceuticals, LPIndustry (pharma, biotech, devices)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥12 years of age at the time of informed consent
- Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
- Confirmed medical history of EoE
- Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
- Willing and able to adhere to the treatment regimen and visit schedule
Key exclusion criteria (6 listed)
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- Have signs and symptoms of adrenal suppression or hypercorticism
- Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- Have current alcohol or drug abuse in the opinion of the Investigator
- Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APT-1011 3 mg HSAlso: fluticasone propionateAPT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APT-1011 3 mg HS in people with Eosinophilic Esophagitis, run by Ellodi Pharmaceuticals, LP at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.