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21 Participants Needed

Dupilumab for Eosinophilic Esophagitis

Overseen BySharon Carbonara

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital of Philadelphia

Must be taking: Proton pump inhibitors

Must not be taking: Systemic immunosuppressants, Biologics

Disqualifiers: Inflammatory bowel disease, Barrett's, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests if a treatment can help people with EoE reintroduce foods that usually cause their symptoms. The treatment works by reducing inflammation in the body, potentially allowing these patients to eat foods like milk, egg, wheat, and soy without issues.

Research Team

Jonathan Spergel, MD, PhD | Children's ...

Jonathan M Spergel, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children and young adults aged 6 to 25 with Eosinophilic Esophagitis (EoE) triggered by milk, egg, soy, or wheat. Participants must have a history of EoE confirmed by endoscopy within the last two years and weigh over 10 kg. They should be on a stable dose of Proton Pump Inhibitors and not have used biologics or immunotherapy recently. Girls over 11 need a negative pregnancy test.

Inclusion Criteria

History of either milk, egg, soy or wheat induced EoE in the last two years

Weight > 10 kg

I have been diagnosed with Eosinophilic Esophagitis according to the latest guidelines.

See 5 more

Exclusion Criteria

Allergy or known hypersensitivity to the dupilumab

Excessive anxiety and unlikely to cope with the conditions of an upper Endoscopy and biopsy

I have not had biologic therapy in the last year.

See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants start on dupilumab for disease control

12 weeks

Endoscopy at week 12

Food Introduction

Participants introduce EoE trigger foods into their diet

24 weeks

Endoscopy at weeks 24 and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Endoscopy at week 48

Treatment Details

Interventions

Dupilumab

Trial Overview The study tests if Dupilumab, an inhibitor targeting type-2 inflammation, can help patients with EoE reintroduce foods that previously caused allergic reactions into their diets without triggering symptoms. It's conducted at one site and involves introducing specific foods while monitoring the effects.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Study GroupExperimental Treatment4 Interventions

30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy) Dosing: \>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks 6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W

Dupilumab is already approved in United States, European Union for the following indications: