FDA-Approved drug shows promise for Tough-to-Treat EoE with strictures
NCT ID NCT06352073
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well dupilumab, an already approved drug, works for people with severe eosinophilic esophagitis (EoE) that has caused narrowing of the esophagus. About 23 participants aged 16 and older will receive weekly injections of dupilumab for one year. The goal is to see if the drug can reduce inflammation and improve swallowing, potentially reducing the need for dilation procedures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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23 people
The number who actually took part.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Requirements to be eligible for the study: 1. Age 16 and older. 2. Diagnosis of EoE (per 2018 AGREE consensus guidelines). 3. Currently active EoE (defined as ≥15 eos/hpf \[eosinophils per high power field\]) based on samples taken from the screening endoscopy. 4. Prior intolerance to or histologic non-response (defined as a peak esophageal eosinophil count of ≥15 eos/hpf) to proton pump inhibitors (PPI) and topical corticosteroids (tCS). * For PPI, this must be after 8 weeks or more of treatment of at least 40mg daily of any of the approved medications. * For tCS, this must be after 8 weeks or more of treatment of at least 2mg daily for budesonide or 1760 mcg daily for fluticasone). 5. One of the following specific EoE features: * A narrow esophagus (previous endoscopy with a severe, \<10mm area of narrowing or where a standard adult endoscope would not fit), OR * 4 or more prior esophageal dilations (stretching procedures) with at least 2 dilations occurring within one year. 6. Willing to follow certain lifestyle considerations during the study including: * No diet changes, * No changes in PPI medication (such as omeprazole \[Prilosec\], esomeprazole \[Nexium\], lansoprazole \[Prevacid\], etc) dose, * No topical/swallowed (such as flucticasone \[Flovent\], budesonide \[Eohilia\], etc) or systemic steroids (such as prednisone) for add-on EoE therapy, * Use highly effective birth control methods (for people assigned female at birth who are able to get pregnant). 7. Weigh at least 40kg (about 89 pounds or more). Reasons a participant could be excluded: 1. Other eosinophilic gastrointestinal (GI) disease including: * Eosinophilic gastritis, * Eosinophilic enteritis, * Eosinophilic colitis, * Hypereosinophilic syndrome. 2. Recent steroid use (systemic or swallowed/topical corticosteroid within 4 weeks prior to the screening endoscopy). 3. Recent use of dupilumab (Dupixent) (within about 5 months of screening) or prior allergic reaction to dupilumab or its components, or dupilumab intolerance. 4. Recent use of other biologic medications (within either 5 months or 5 half-lives, whichever is longer). Examples of biologic medications include: * mepolizumab (Nucala), * reslizumab (Cinqair, Cinqaero), * benralizumab (Fasenra), * cendakimab, * tezepelumab (Tezspire), * barzolvolimab, etc. 5. Prior esophageal resection (surgery to remove the esophagus). 6. Participants taking blood thinners (such as coumadin, warfarin, heparin, etc.) who are unable to stop taking them for a brief period prior to EGD (as required by normal clinical practice). 7. Recent vaccination with a live (attenuated) vaccine (within 4 weeks of screening). Live vaccines include: * Chickenpox (varicella), * FluMist and Intranasal influenza, * Measles (rubeola), * Mumps, * Rubella, * Oral polio, * Oral typhoid, * Smallpox (vaccinia), * Yellow fever, * Bacille Calmette-Guerin * Rotavirus * Combination vaccines of any of the above. 8. Study doctor's determination that it would not be medically safe to complete an EGD. 9. Inability to read or understand English. 10. Currently pregnant or breastfeeding. 11. Currently in screening or eligible for another study of dupilumab (Dupixent).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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Other studies related to the condition(s) this trial covers.
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