Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.

NCT07358234 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: 25-005776
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

dupilumab; budesonide oral suspension; Eohilia; Dupixent

Outcome Measures

Primary Outcomes (1)

• Esophageal diameter

  the minimum esophageal diameter after 12 weeks of treatment.

  from enrollment until up to 14 weeks

Secondary Outcomes (7)

• Distensibility and diameter change

  from baseline to end of treatment at 14 weeks

• EEsAI questionnaire scores

  from enrollment to the end of treatment at 12 weeks

• Endoscopic refernece score (EREFS)

  from enrollment up to end of treatment at 12 weeks

• Eosinophil counts

  from enrollment to the end of treatment at 12 weeks

• Eoe Histologic Scoring system (EoEHSS)

  from enrollment to end of treatment at 12 weeks

Study Arms (2)

budesonide oral suspension (Eohilia)

ACTIVE COMPARATOR

2mg twice daily

Drug: budesonide oral suspension

dupilumab (Dupixent)

ACTIVE COMPARATOR

300 mg weekly injection

Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] DRUG

300 mg weekly injection

dupilumab (Dupixent)

budesonide oral suspension DRUG

2mg twice daily

Also known as: Eohilia

budesonide oral suspension (Eohilia)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (2)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Diana Snyder, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Jennifer Horsley-Silva, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 22, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)