ClinicalTrials.gg
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

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies testing dupilumab in Eosinophilic Esophagitis — 4 open to participants now, 7 under way, 1 of them phase 3. dupilumab · Eosinophilic Esophagitis.

Planned enrollment
3rd of 11
72 · median 47
Started
2024
with 2 others
Phase 2
3 of 11
1 open now
Registered
8th of 11
by date
Lead sponsor
1 of 11
University of Colorado, Denver

Among the 11 studies testing dupilumab in Eosinophilic Esophagitis, this one is the 3rd largest by planned enrollment, is one of 3 that started in 2024, is one of 3 in phase 2, and was the 8th registered.

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

Browse Eosinophilic Esophagitis studies →

Open to participants now

4 of the 11 studies testing dupilumab in Eosinophilic Esophagitis are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

About dupilumab

dupilumab: first FDA approval 2017 (DUPIXENT), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.

This study: 12 Years to 25 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies testing dupilumab in Eosinophilic Esophagitis, or all of them as a file.
02

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
03

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • Dupilumab
  • Fluticasone
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

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

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

    Also known as: Flovent

06

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.

07

Study locations

1 of 1 sites recruiting
  • Children's Hospital Colorado/University of Colorado School of Medicine
    Aurora, Colorado 80045, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Sep 2026, 21 months after the start.

Of 24 phase 2 interventional studies under Eosinophilic Esophagitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 28. This study's planned 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2024
First posted
Nov 26, 2024
StartActual
Dec 23, 2024
Primary completionEst.
Sep 2026
CompletionEst.
Mar 2027
Last update
Mar 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06705387
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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Studies of the drugs tested here: Dupilumab · Fluticasone

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