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Can a drug let kids with EoE eat eggs and milk again? small trial aims to find out.

NCT ID NCT05247866

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tested whether the drug dupilumab can help children and young adults (ages 6 to 25) with eosinophilic esophagitis (EoE) safely reintroduce foods that normally trigger their symptoms. EoE is a condition where certain foods cause inflammation in the esophagus, and current treatments often require strict food avoidance. The trial enrolled 21 participants and measured changes in esophageal inflammation and symptom scores after adding back trigger foods while on dupilumab.

What this could mean

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

Active substance
dupilumab
What this could lead to
If successful, this could allow children with eosinophilic esophagitis to eat foods they previously had to avoid, improving their quality of life.
What could go wrong
This is a very small, single-site study with only 21 participants, so results may not apply to everyone. It is also a Phase 4 trial, meaning dupilumab is already approved for other conditions, but its effect on food reintroduction is still uncertain.

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

21 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

Lead sponsor

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

6 to 25 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.

Inclusion Criteria: 1. Males or females age 6 to 25 years 2. Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition (Dellon et al, Gastroenterology 2019) a) History of endoscopy with a peak count of \>15 eosinophils per high powered field meeting consensus criteria for Eosinophilic Esophagitis1 3. History of either milk, egg, soy or wheat induced EoE based on the following criteria in the last two years 1. Addition of a single food lead to exacerbation of esophageal eosinophilia (increase of greater than 15 eos/hpf) or 2. Removal of a single food lead to normalization of biopsy (esophageal eosinophilia showed less than 6 eos/hpf) AND 3. History of either milk, egg, soy or wheat induced EoE based on introduction of the food and symptoms in the last 12 months 4. Weight \> 10 kg 5. Ability to remain on stable dose of Proton Pump Inhibitor (PPI) therapy throughout the study 6. Girls \> 11 years of age must have a negative urine/serum pregnancy test. 7. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: 1. Tracheo-esophageal fistulas, inflammatory bowel disease, Barrett's disease, or other significant inflammatory disease of the gastrointestinal tract 2. Biopsy evidence of eosinophilic infiltration in any other organ system 3. History of significant esophageal procedures e.g. sclerotherapy or esophagectomy 4. Systemic immunosuppressant usage in prior 3 months 5. Narrow caliber esophagus defined as the inability to pass a 9.5 mm endoscopy into the esophagus 6. IgE mediated reaction to food (milk, egg, soy or wheat) being introduced in the last 12 months 7. Therapy with biologic molecule (e.g. omalizumab, infliximab) in prior 12 months 8. Any factors that may pose a significant risk for undergoing anesthesia/sedation 9. Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) within 3 months prior to Visit 1. 10. Active IgE- mediated milk, egg, wheat or soy allergy based on skin test or history (if those foods are being introduced back into the diet). 11. Allergy or known hypersensitivity to the dupilumab. 12. Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper Endoscopy and biopsy. 13. Past or current disease(s), which in the opinion of the Investigator or the Sponsor, may affect the subject's participation in this study, including but not limited to active autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders). 14. Participation in another clinical intervention study in the three months prior to Visit 1. 15. Subjects unable to follow the protocol and the protocol requirements. 16. Subjects on any experimental drugs or treatments. 17. Subjects unable to read/understand English or follow the protocol and the protocol requirements. 18. Subjects unable to read/understand English or follow the protocol and the protocol requirements. 19. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit or throughout the trial 20. Major elective surgeries are prohibited during the study 21. Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study 22. Women of children bearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. This includes female patients who experience menarche during the study duration and who are unwilling to follow the precautions for WOCBP. 23. Chronic or acute infection requiring treatment with systemic antibiotic, antivirals, or antifungal within 2 weeks of baseline visits a. Patients maybe rescreened after infection resolves 24. Participants with active or suspected parasitic infection are excluded.

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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

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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