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New hope for kids with swallowing trouble: drug targets esophageal inflammation

NCT ID NCT04394351

Disease control Sponsor: Regeneron Pharmaceuticals 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested dupilumab (Dupixent) in 102 children with active eosinophilic esophagitis, a condition where white blood cells build up in the esophagus, causing pain and swallowing problems. The drug aims to reduce inflammation and improve tissue health. Results will show if dupilumab is safe and effective compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dupilumab (Dupixent)
What this could lead to
If successful, dupilumab could offer a new treatment option for children with eosinophilic esophagitis, reducing inflammation and easing symptoms.
What could go wrong
This is a Phase 3 trial, but results may not confirm long-term benefit or safety. Side effects like injection reactions or infections are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

102 people

The number who actually took part.

Started

Sep 2020

Finished

May 2024

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

1 year to 11 years

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.

Key Inclusion Criteria: 1. A documented diagnosis of eosinophilic esophagitis (EoE) 2. Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration Key Exclusion Criteria: 1. Body weight \<5 kg or ≥60 kg at screening 2. Other causes of esophageal eosinophilia 3. Active Helicobacter pylori 4. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery 5. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening 6. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy 7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure 8. Active parasitic infection or suspected parasitic infection 9. Known or suspected immunodeficiency disorder Key Exclusion for Patients Re-Entering the Study (for Entry into Part C, as defined in protocol): 1. Patients who are ≥12 years old, weigh ≥40 kg (or minimum weight for which dupilumab is approved for EoE), and dupilumab is commercially available for the treatment of EoE in their country 2. Patients who, during their previous participation in this clinical trial, developed an SAE and/or AE deemed related to dupilumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient 3. Patients who did not undergo endoscopy with biopsies at week 16 and/or week 52 or prior to receiving rescue treatment Note: If the endoscopy with biopsies could not occur due to COVID-19 restrictions and rescue treatment was needed to be initiated without delay, these patients will be eligible to participate in Part C 4. Patients who became pregnant during their previous participation in this dupilumab clinical trial 5. Patients who, during their previous participation in this trial, were prematurely withdrawn because of a protocol violation, poor compliance, or inability to complete required study assessments NOTE: Other protocol defined inclusion/exclusion criteria apply

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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 esophagitis (EOE)

Contacts and locations

Locations

  • Regeneron Study Site

    Phoenix, Arizona, 85016, United States

  • Regeneron Study Site

    Little Rock, Arkansas, 72202, United States

  • Regeneron Study Site

    Los Angeles, California, 90027, United States

  • Regeneron Study Site

    San Francisco, California, 94143, United States

  • Regeneron Study Site

    Aurora, Colorado, 80045, United States

  • Regeneron Study Site

    St. Petersburg, Florida, 33701, United States

  • Regeneron Study Site

    Atlanta, Georgia, 30322, United States

  • Regeneron Study Site

    Atlanta, Georgia, 30342, United States

  • Regeneron Study Site

    Chicago, Illinois, 60611, United States

  • Regeneron Study Site

    Indianapolis, Indiana, 46202, United States

  • Regeneron Study Site

    Iowa City, Iowa, 52242, United States

  • Regeneron Study Site

    Boston, Massachusetts, 02111, United States

  • Regeneron Study Site

    Boston, Massachusetts, 02114, United States

  • Regeneron Study Site

    Boston, Massachusetts, 02115, United States

  • Regeneron Study Site

    Lincoln, Nebraska, 68510, United States

  • Regeneron Study Site

    New York, New York, 10029, United States

  • Regeneron Study Site

    New York, New York, 10032, United States

  • Regeneron Study Site

    New York, New York, 10065, United States

  • Regeneron Study Site

    Chapel Hill, North Carolina, 27599, United States

  • Regeneron Study Site

    Cincinnati, Ohio, 45229, United States

  • Regeneron Study Site

    Cleveland, Ohio, 44106, United States

  • Regeneron Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Regeneron Study Site

    Dallas, Texas, 75207, United States

  • Regeneron Study Site

    Fort Worth, Texas, 76104, United States

  • Regeneron Study Site

    Houston, Texas, 77030, United States

  • Regeneron Study Site

    Milwaukee, Wisconsin, 53226, United States

  • Regeneron Study Site

    London, Ontario, N6A 5W9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.