A Study Of Budesonide Oral Suspension With Subcutaneous Dupilumab On Esophageal Diameter And Fibrotic Change In EOE

Overview

About this study

The purpose of this study is to determine the effect of dupilumab versus budesonide suspension on esophageal diameter in patients with EoE.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/5/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Diana Snyder

Open for enrollment

Contact information:

Mariah Robran

(507) 266-3595

robran.mariah@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jennifer Horsley-Silva

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available