Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

NCT06705387 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 23-23671R01DK135692-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to \[primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.\] in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main question\[s\] it aims to answer \[is/are\]: Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population? Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response. Participants will be asked to:

• Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily.
• Participate in 8 study visits over 52 weeks
• Complete questionnaires
• Have an endoscopy with biopsies and EndoFLIP measurements.
• Swallow an Esophageal String Test

Conditions

Eosinophilic Esophagitis

Keywords

Dupilumab; Fluticasone

Outcome Measures

Primary Outcomes (2)

• Esophageal Lumen Distensibility

  Change in distensibility (mm) from baseline to end of treatment (continuous). This is measured by EndoFLIP.

  From baseline endoscopy to the end of treatment at week 16.

• Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)

  The number of patients meeting a reduction in epithelial eosinophilia on esophageal biopsies of \<15 eos/hpf at end of treatment.

  This will be measured at week 16 end of treatment.

Secondary Outcomes (1)

• Change in daily symptom questionnaire (DSQ) severity score

  From screening to the end of treatment at week 16.

Study Arms (2)

dupilumab (also known as Dupixent)

ACTIVE COMPARATOR

Biological: Dupilumab

fluticasone (also known as Flovent)

ACTIVE COMPARATOR

Drug: Fluticasone

Interventions

Dupilumab BIOLOGICAL

Subcutaneous injection of 300mg per week for 16 weeks.

Also known as: Dupixent

dupilumab (also known as Dupixent)

Fluticasone DRUG

Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

Also known as: Flovent

fluticasone (also known as Flovent)

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Seen at CHCO for clinical care.
• Age 12 - 25 years old inclusive
• Weight ≥40 kg at the time of screening visit
• Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
• Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
• Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)

You may not qualify if:

• Esophageal dilation performed at index endoscopy
• Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
• Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
• Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
• Patients who have received dupilumab in the past 12 months for any indication are excluded.
• Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.
• Patients with a fasting morning cortisol \<5 within 2 months of screening will not be enrolled. If repeat cortisol levels are normal, patients can be reconsented.
• Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.
• Patients with a known gelatin allergy will be excluded from EST collection.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital Colorado/University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

dupilumab; Fluticasone

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Michelle Landis, BS

CONTACT

720-777-8884; michelle.landis@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: November 26, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)