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RecruitingNCT06705387DeTECTSUpdated Mar 14, 2025

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

A Phase 2 interventional study of Dupilumab and Fluticasone in Eosinophilic Esophagitis, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
12 Years to 25 Years
Sex
All
01

Study 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
02

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • Dupilumab
  • Fluticasone
03

Who can participate

Ages eligible
12 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    dupilumab (also known as Dupixent)

    Biological: Dupilumab

  • Active comparator
    fluticasone (also known as Flovent)

    Drug: Fluticasone

Interventions

  • BiologicalDupilumab

    Subcutaneous injection of 300mg per week for 16 weeks.

    Also known as: Dupixent

  • DrugFluticasone

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

    Also known as: Flovent

05

What researchers measure

Primary outcomes

  1. Esophageal Lumen Distensibility

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

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

  2. 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.

    Time frame: This will be measured at week 16 end of treatment.

Secondary outcomes

  1. Change in daily symptom questionnaire (DSQ) severity score

    The change in daily symptoms as measured by the DSQ severity score from enrollment to end of treatment at week 16. A possible DSQ score can range between 0 and 84.

    Time frame: From screening to the end of treatment at week 16.

06

Study locations

1 of 1 sites recruiting
  • Children's Hospital Colorado/University of Colorado School of Medicine
    Aurora, Colorado 80045, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06705387
Lead sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Nov 26, 2024
Start date
Dec 23, 2024
Primary completion
Sep 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Mar 14, 2025

Study contacts

Michelle Landis, BS
Contact
michelle.landis@childrenscolorado.org
720-777-8884

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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