What side effects are associated with this type of intervention?

Common treatments for Eosinophilic Esophagitis (EoE) include diet modifications, proton pump inhibitors, topical steroids, and biologics such as dupilumab. Dupilumab, which inhibits IL-4 and IL-13 signaling to reduce type 2 inflammation, has been associated with side effects like injection site reactions, upper respiratory tract infections, headache, and nasopharyngitis. Other biologics used for similar inflammatory conditions may have comparable side effects, including increased risk of infections and potential allergic reactions. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Eosinophilic Esophagitis (EoE) that target IL-4 and IL-13 signaling similar to Dupilumab. Current therapies for EoE include dietary management, proton pump inhibitors, and topical corticosteroids. Dupilumab, which is being studied for its efficacy in EoE, works by inhibiting IL-4 and IL-13 signaling to reduce type 2 inflammation, a mechanism not yet approved for EoE treatment.

What other types of research exist?

Promising alternatives to Dupilumab for Eosinophilic Esophagitis patients include proton pump inhibitors (PPIs), topical steroids, and other biologics targeting type 2 inflammation. Emerging treatments such as anti-IL-5 and anti-IL-13 antibodies are also being explored and may offer new options in the near future.

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Monoclonal Antibodies

Dupilumab for Eosinophilic Esophagitis

Phase 4

Waitlist Available

Led By Jonathan Spergel, MD, PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition

Males or females age 6 to 25 years

Must not have

Therapy with biologic molecule in prior 12 months

Subjects unable to follow the protocol and the protocol requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Dupilumab may include allergic reactions at the injection site, eye irritation or redness, cold sores in your mouth or throat area, joint pain(s), and inflammation around your heart.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 6 and 25 years old.

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I have been diagnosed with Eosinophilic Esophagitis based on an endoscopy.

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I can stay on my current dose of acid reflux medication during the study.

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I am a girl over 11 and my pregnancy test is negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had biologic therapy in the last year.

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I can follow all study requirements.

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I do not have an active or suspected parasitic infection.

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I have biopsy proof of eosinophilic infiltration in an organ.

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I will not have any major elective surgeries during the study.

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I have had major procedures on my esophagus.

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I have not received a live vaccine within the last 4 weeks.

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I do not have significant inflammatory diseases of the digestive system.

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I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Esophageal Eosinophilia (number of eosinophils in the esophagus)

Secondary study objectives

Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)

Other study objectives

Change in endoscopic Scoring system (EREFS)

Changes in EoE Quality of life from baseline

Rate of Maintenance of Remission (less than <6 eos/hpf) in esophageal biopsy

+1 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Eosinophilic Esophagitis (EoE) is primarily treated through dietary management, proton pump inhibitors (PPIs), and biologics like Dupilumab. PPIs reduce acid production, which can help decrease eosinophil activity in the esophagus. Dupilumab, a biologic, inhibits IL-4 and IL-13 signaling, reducing type 2 inflammation, which is crucial in EoE as it directly targets the inflammatory pathways responsible for eosinophil accumulation and tissue damage. This targeted approach can significantly improve symptoms and quality of life for EoE patients by addressing the underlying inflammatory processes.