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
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Among 11 studies testing dupilumab in Eosinophilic Esophagitis — 4 open to participants now, 7 under way, 1 of them phase 3. dupilumab · Eosinophilic Esophagitis.
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.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
Browse Eosinophilic Esophagitis studies →4 of the 11 studies testing dupilumab in Eosinophilic Esophagitis are open now, in 1 country. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 6 mo–6 yrs
University of California, San Diego · Sites in United States
Ages 22+
Mayo Clinic · Sites in United States
Ages 18+
By country, each count listing its studies:
dupilumab: first FDA approval 2017 (DUPIXENT), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
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 →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, dupilumab is the treatment under test here. Read study by study →
11 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is above the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Median enrollment 47 across the 11 interventional studies. Of the 4 that completed or were terminated, 4 (100%) have results posted.
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6 of 11 have an industry lead sponsor. The 7 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 8 studies filed under Eosinophilic Esophagitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing dupilumab in Eosinophilic Esophagitis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Dupilumab
Drug: Fluticasone
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
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
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.
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Studies of the drugs tested here: Dupilumab · Fluticasone
University of Colorado, Denver →