Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07358234
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥18 year of age at Mayo Clinic Rochester or Mayo Clinic Scottsdale at time of informed consent
4. Have a documented diagnosis of EoE per standard guidelines
5. Have histologically active EoE (defined as a peak eosinophil count \>15 eosinophils per high-power field; eos/hpf)
6. Weight ≥40 kg
7. Ability to take injectable or oral medication and be willing to adhere to the study intervention regimen
8. 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.
9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
10. Subject agrees to maintain a stable diet
11. Subject is willing to receive weekly injections throughout the study
12. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
1. Inability to provide informed consent
2. Pregnancy or lactation
3. Contraindication to performing upper endoscopy
4. Known allergic reactions to components of dupilumab or budesonide suspension
5. Non-EoE eosinophilic GI diseases (EGIDs) or hypereosinophilic disorders
6. Prior esophageal surgery, coagulopathy or esophageal varices
7. Known achalasia, crohn's disease, ulcerative colitis, celiac disease
8. Child-Pugh Class C liver disease
9. Failed dupilumab
10. Failed swallowed topical budesonide
11. Erosive esophagitis LA B and above found during EGD
12. Use of prednisone within 2 months prior to study enrollment
13. Treatment with biologic therapies for other disease indications
14. Treatment with medium or high potency topical steroids for skin conditions
15. Autoimmune conditions including lupus, rheumatoid arthritis and psoriatic arthritis
16. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07358234
Study Brief:
Protocol Section:
NCT07358234