Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.
Enrolling by invitation · Early Phase 1
Conditions studied: Eosinophilic Esophagitis (EoE)
In brief
The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.
Key facts
- Study ID
- NCT07358234
- Run by
- Mayo Clinic
- People needed
- 60
- Starts
- 2026-02-04
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Mayo Clinic — Scottsdale, Arizona, United States
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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