Eosinophilic Esophagitis (EoE)Early Phase 1NCT07358234
Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.
A Early Phase 1 study testing Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] and budesonide oral suspension in people with Eosinophilic Esophagitis (EoE), run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] and budesonide oral suspension
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2026to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 year of age at Mayo Clinic Rochester or Mayo Clinic Scottsdale at time of informed consent
- Have a documented diagnosis of EoE per standard guidelines
- Have histologically active EoE (defined as a peak eosinophil count >15 eosinophils per high-power field; eos/hpf)
- Weight ≥40 kg
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- Ability to take injectable or oral medication and be willing to adhere to the study intervention regimen
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks after the end of dupilumab or budesonide suspension administration. Willingness to complete pregnancy tests during study visits and at end of study.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- Subject agrees to maintain a stable diet
- Subject is willing to receive weekly injections throughout the study
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Inability to provide informed consent
- Pregnancy or lactation
- Contraindication to performing upper endoscopy
- Known allergic reactions to components of dupilumab or budesonide suspension
- Non-EoE eosinophilic GI diseases (EGIDs) or hypereosinophilic disorders
- Prior esophageal surgery, coagulopathy or esophageal varices
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- Known achalasia, crohn's disease, ulcerative colitis, celiac disease
- Child-Pugh Class C liver disease
- Failed dupilumab
- Failed swallowed topical budesonide
- Erosive esophagitis LA B and above found during EGD
- Use of prednisone within 2 months prior to study enrollment
- Treatment with biologic therapies for other disease indications
- Treatment with medium or high potency topical steroids for skin conditions
- Autoimmune conditions including lupus, rheumatoid arthritis and psoriatic arthritis
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: Prospective Trial Comparing Swallowed Topical Budesonide With Subcutaneous Dupilumab on Esophageal Diameter and Fibrotic Change in Eosinophilic Esophagitis
The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.
Read the detailed description
Eosinophilic esophagitis (EoE) is a chronic disease mediated by environmental allergens and type 2 immune inflammation which causes significant symptoms, food impactions, and stenosis. EoE is associated with significant esophageal stricturing disease. In particular, the odds of developing fibrostenotic disease in EoE more than double per decade of life, and the longer symptoms are present prior to diagnosis and treatment, the higher the likelihood of esophageal strictures being present.
Dupilumab and budesonide oral suspension are key treatments for EoE. Dupilumab was FDA approved for EoE in 2022 and inhibits IL-4 and IL-13 signaling which mediate type-2 inflammation and may have an anti-fibrotic effect. IL-13 promotes M2 macrophage polarization, and a recent study showed fibrosis was macrophage-dependent in a mouse model of EoE. Swallowed topical steroids have been used off label in patients with EoE for several years with studies showing effects on improvement in esophageal diameter and reduction in esophageal strictures. The budesonide oral suspension was recently FDA approved in 2024. Further study is needed to understand the effect of these treatments on esophageal stenosis and fibrosis as no clinical trials have compared these treatments or their effects on esophageal diameter to date. Barium esophagram and functional lumen imaging probe (FLIP) are important tools used to measure esophageal diameter in EoE. The investigators hypothesize that dupilumab is superior to topical budesonide oral suspension for its effect on esophagram minimum diameter and FLIP distensibility plateau in EoE patients.
- Primary Efficacy Endpoint:
Alternative Hypothesis: There will be a greater increase in minimum esophageal diameter in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks.
- Secondary Efficacy Endpoint(s):
Alternative Hypothesis: There will be greater distensibility on EndoFLIP topography in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. Symptoms, endoscopic findings, and histologic severity will be improved in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. Lamina propria fibrosis and collagen fiber density as determined by second harmonic generation microscopy will be improved in the dupilumab group in comparison to the budesonide oral suspension group.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT], budesonide oral suspension
- Keywords
- dupilumab, budesonide oral suspension, Eohilia, Dupixent
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]Drug
300 mg weekly injection
budesonide oral suspensionDrug
Also called Eohilia
2mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| budesonide oral suspension (Eohilia) | Active comparator | 2mg twice daily Receives: Drug: budesonide oral suspension |
| dupilumab (Dupixent) | Active comparator | 300 mg weekly injection Receives: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal diameter
the minimum esophageal diameter after 12 weeks of treatment.
Measured: from enrollment until up to 14 weeks
Secondary outcomes (7)
Distensibility and diameter change
Secondary outcomes will include distensibility and change in minimum diameter as measured by endoFLIP topography
Measured: from baseline to end of treatment at 14 weeks
EEsAI questionnaire scores
comparison of questionnaires that are scored 0-100 before and after treatment.
Measured: from enrollment to the end of treatment at 12 weeks
Endoscopic refernece score (EREFS)
comparison of EREFs scores on scale of 0-9 at EGDs
Measured: from enrollment up to end of treatment at 12 weeks
Eosinophil counts
number of eosinophils found in biopsy during EGD
Measured: from enrollment to the end of treatment at 12 weeks
Eoe Histologic Scoring system (EoEHSS)
An EoEHSS score is given by looking at a biopsy taken during an endoscopy. The score is based on observation of the appearance of the biopsy under a microscope. Score range is 0 to 1
Measured: from enrollment to end of treatment at 12 weeks
M2 macrophage polarization
comparison of myofibroblast differentiation
Measured: from enrollment to end of treatment at 12 weeks
Lamina propria remodeling
characterizing Lamina propria remodeling by second harmonic imaging microscopy
Measured: from enrollment to end of treatment at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start4 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Diana L. Snyder, Mayo Clinic
- Investigators
- Diana Snyder, M.D., Principal investigator, Mayo ClinicJennifer Horsley-Silva, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358234
- Sponsor's protocol ID
- 25-005776
- Status last verified
- May 2026
- First submitted
- 23 Dec 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Comparing Swallowed Topical Budesonide With Subcutaneous Dupilumab on Esophageal Diameter and Fibrotic Change in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT07358234
- Acronym / sponsor ID
- 25-005776
- Conditions
- Eosinophilic Esophagitis (EoE)
- Keywords
- dupilumab, budesonide oral suspension, Eohilia, Dupixent
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (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.
The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.
Detailed description
Eosinophilic esophagitis (EoE) is a chronic disease mediated by environmental allergens and type 2 immune inflammation which causes significant symptoms, food impactions, and stenosis. EoE is associated with significant esophageal stricturing disease. In particular, the odds of developing fibrostenotic disease in EoE more than double per decade of life, and the longer symptoms are present prior to diagnosis and treatment, the higher the likelihood of esophageal strictures being present.
Dupilumab and budesonide oral suspension are key treatments for EoE. Dupilumab was FDA approved for EoE in 2022 and inhibits IL-4 and IL-13 signaling which mediate type-2 inflammation and may have an anti-fibrotic effect. IL-13 promotes M2 macrophage polarization, and a recent study showed fibrosis was macrophage-dependent in a mouse model of EoE. Swallowed topical steroids have been used off label in patients with EoE for several years with studies showing effects on improvement in esophageal diameter and reduction in esophageal strictures. The budesonide oral suspension was recently FDA approved in 2024. Further study is needed to understand the effect of these treatments on esophageal stenosis and fibrosis as no clinical trials have compared these treatments or their effects on esophageal diameter to date. Barium esophagram and functional lumen imaging probe (FLIP) are important tools used to measure esophageal diameter in EoE. The investigators hypothesize that dupilumab is superior to topical budesonide oral suspension for its effect on esophagram minimum diameter and FLIP distensibility plateau in EoE patients.
- Primary Efficacy Endpoint:
Alternative Hypothesis: There will be a greater increase in minimum esophageal diameter in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks.
- Secondary Efficacy Endpoint(s):
Alternative Hypothesis: There will be greater distensibility on EndoFLIP topography in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. Symptoms, endoscopic findings, and histologic severity will be improved in patients receiving dupilumab compared to budesonide oral suspension at 12 weeks. Lamina propria fibrosis and collagen fiber density as determined by second harmonic generation microscopy will be improved in the dupilumab group in comparison to the budesonide oral suspension group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| budesonide oral suspension (Eohilia) | Active comparator | Drug: budesonide oral suspension2mg twice daily |
| dupilumab (Dupixent) | Active comparator | Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]300 mg weekly injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 year of age at Mayo Clinic Rochester or Mayo Clinic Scottsdale at time of informed consent
- Have a documented diagnosis of EoE per standard guidelines
- Have histologically active EoE (defined as a peak eosinophil count >15 eosinophils per high-power field; eos/hpf)
Key exclusion criteria (16 listed)
- Inability to provide informed consent
- Pregnancy or lactation
- Contraindication to performing upper endoscopy
- Known allergic reactions to components of dupilumab or budesonide suspension
- Non-EoE eosinophilic GI diseases (EGIDs) or hypereosinophilic disorders
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 |
|---|---|---|
| Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]300 mg weekly injection | Drug | dupilumab (Dupixent) |
| budesonide oral suspensionAlso: Eohilia2mg twice daily | Drug | budesonide oral suspension (Eohilia) |
Primary outcome
Esophageal diameter
Time frame: from enrollment until up to 14 weeks
the minimum esophageal diameter after 12 weeks of treatment.
7 secondary outcomes
Distensibility and diameter change
Time frame: from baseline to end of treatment at 14 weeks
EEsAI questionnaire scores
Time frame: from enrollment to the end of treatment at 12 weeks
Endoscopic refernece score (EREFS)
Time frame: from enrollment up to end of treatment at 12 weeks
Eosinophil counts
Time frame: from enrollment to the end of treatment at 12 weeks
Eoe Histologic Scoring system (EoEHSS)
Time frame: from enrollment to end of treatment at 12 weeks
M2 macrophage polarization
Time frame: from enrollment to end of treatment at 12 weeks
Lamina propria remodeling
Time frame: from enrollment to end of treatment at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Esophagitis (EoE)
RecruitingPhase 2
A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
EoE, Eosinophilic Esophagitis
RecruitingPhase 3
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE)
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
Active, not recruitingObservational study
A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
Eosinophilic Esophagitis (EoE)
Enrolling by invitationObservational study
The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE), Dysphagia, Esophageal
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.
Diana Snyder, M.D. principal investigator
Mayo Clinic
Jennifer Horsley-Silva, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] and budesonide oral suspension in people with Eosinophilic Esophagitis (EoE), run by Mayo Clinic at 2 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 12 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Esophageal diameter (time frame: from enrollment until up to 14 weeks). It is what the study was designed to measure, not a finding.
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 4 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.