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New hope for swallowing: drug targets esophagus scarring in EoE

NCT ID NCT06101095

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a medication called dupilumab in 69 adults with eosinophilic esophagitis, a condition that makes swallowing difficult due to inflammation and scarring in the esophagus. Participants receive either dupilumab or a placebo for 24 weeks, then everyone gets dupilumab for another 104 weeks. The goal is to see if the drug improves how well the esophagus can stretch and function, helping people eat more easily.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

69 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A documented diagnosis of EoE by endoscopic biopsy. * Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration. * History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening. * Body weight ≥40 kg. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome). * Active Helicobacter pylori infection. * History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery. * Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening. * History of bleeding disorders or esophageal varices. * Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline. * Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening. * Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic oesophagitis

Contacts and locations

Locations

  • Borland Groover Clinic- Site Number : 8400016

    Jacksonville, Florida, 32256, United States

  • Cleveland Clinic - Cleveland- Site Number : 8400009

    Cleveland, Ohio, 44195, United States

  • Clinica de Alergia Martti Antila- Site Number : 0760001

    Sorocaba, São Paulo, 18040-425, Brazil

  • Clínica Loema - Unidade I- Site Number : 0760007

    Campinas, São Paulo, 13010-001, Brazil

  • GI Alliance - Glenview- Site Number : 8400012

    Glenview, Illinois, 60026, United States

  • GI Alliance - Mansfield- Site Number : 8400017

    Mansfield, Texas, 76063, United States

  • Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760003

    São Paulo, 01323-020, Brazil

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Illinois Gastroenterology Group- Site Number : 8400004

    Gurnee, Illinois, 60031, United States

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4A 3T2, Canada

  • Investigational Site Number : 1240004

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Investigational Site Number : 1240006

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Investigational Site Number : 3760002

    Haifa, 3109601, Israel

  • Investigational Site Number : 3760003

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760004

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760005

    Jerusalem, 9103102, Israel

  • Investigational Site Number : 3760006

    Haifa, 3104802, Israel

  • Investigational Site Number : 7560001

    Wetzikon, 8620, Switzerland

  • Investigational Site Number : 7560002

    Zurich, 8091, Switzerland

  • Itaigara Memorial - Hospital Dia- Site Number : 0760005

    Salvador, Estado de Bahia, 41825-010, Brazil

  • Mayo Clinic Hospital Rochester- Site Number : 8400008

    Rochester, Minnesota, 55905, United States

  • Northwestern University- Site Number : 8400003

    Chicago, Illinois, 60611, United States

  • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010

    Philadelphia, Pennsylvania, 19104, United States

  • Private Practice - Dr. Martin Yudovich- Site Number : 8400015

    Houston, Texas, 77087, United States

  • Treasure Valley Medical Research- Site Number : 8400018

    Boise, Idaho, 83706, United States

  • United Gastroenterologists - Murrieta- Site Number : 8400001

    Murrieta, California, 92563, United States

  • University of California San Francisco - Parnassus Heights- Site Number : 8400020

    San Francisco, California, 94143, United States

  • University of Iowa- Site Number : 8400006

    Iowa City, Iowa, 52242, United States

  • University of Massachusetts Chan Medical School- Site Number : 8400019

    Worcester, Massachusetts, 01655, United States

  • University of North Carolina at Chapel Hill- Site Number : 8400007

    Chapel Hill, North Carolina, 27514, United States