Frontlight ResearchEarly access
Enrolling by invitationEarly phase 1
Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester and Scottsdale, United StatesSee the 2 sites
- Trial code
- Status
- Enrolling by invitation
- Phase
- Early phase 1
- People taking part
- 60 people, planned
- Started
- 4 Feb 2026
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- budesonide oral suspension
- Record updated
- 4 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- 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
- 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 take part
- Prior esophageal surgery, coagulopathy or esophageal varices
- 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
- Known allergic reactions to components of dupilumab or budesonide suspension
- Non-EoE eosinophilic GI diseases (EGIDs) or hypereosinophilic disorders
- Known achalasia, crohn's disease, ulcerative colitis, celiac disease
- Child-Pugh Class C liver disease
- 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
- Inability to provide informed consent
- Pregnancy or lactation
- Contraindication to performing upper endoscopy
- Failed dupilumab
- Failed swallowed topical budesonide
- Erosive esophagitis LA B and above found during EGD
Where in United States
- Mayo ClinicRochester, United StatesEnrolling by invitation
- Mayo ClinicScottsdale, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.
The 2 groups in the trial
- budesonide oral suspension (Eohilia)Existing treatment, for comparison
2mg twice daily
Treatment: budesonide oral suspension
- dupilumab (Dupixent)Existing treatment, for comparison
300 mg weekly injection
Treatment: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Trial Comparing Swallowed Topical Budesonide With Subcutaneous Dupilumab on Esophageal Diameter and Fibrotic Change in Eosinophilic Esophagitis
- Record updated
- 4 May 2026