A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-13

Study Completion Date

2028-12-11

Brief Summary

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This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.

The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

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Detailed Description

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Conditions

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Eosinophilic Esophagitis (EoE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Dosing Regimen 1

Group Type EXPERIMENTAL

dupilumab

Intervention Type DRUG

Administered as defined in the protocol

Dosing Regimen 2

Group Type EXPERIMENTAL

dupilumab

Intervention Type DRUG

Administered as defined in the protocol

Interventions

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dupilumab

Administered as defined in the protocol

Intervention Type DRUG

Other Intervention Names

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DUPIXENT® REGN668 SAR231893

Eligibility Criteria

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Inclusion Criteria

1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \<15 kg at screening with active EoE
2. History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
3. Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol

Exclusion Criteria

1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
2. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study
3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
4. Active Helicobacter pylori infection
5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
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 endoscopic procedure
8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No