Dupilumab for Eosinophilic Esophagitis

Overseen By Sharon 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 84

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dupilumab can help individuals with Eosinophilic Esophagitis (EoE) consume foods like milk, egg, soy, or wheat without issues. EoE causes inflammation in the esophagus, making normal eating difficult. The trial seeks to determine if dupilumab can reduce this inflammation, enabling the reintroduction of these foods into the diet. Individuals who have experienced EoE triggered by these foods in the last two years and can maintain a stable dose of heartburn medication might be suitable for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

You can stay on your current dose of Proton Pump Inhibitor (PPI) therapy during the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

What is the safety track record for dupilumab?

Research has shown that dupilumab is generally safe for treating eosinophilic esophagitis (EoE). Studies have found that patients tolerate it well, with most side effects being mild to moderate. Common side effects include injection site reactions and mild cold-like symptoms. Importantly, the FDA has already approved dupilumab for treating EoE, indicating it has passed strict safety tests for this condition. While some patients might experience more serious reactions, these are less common. Overall, dupilumab's safety is well-established, offering reassurance for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of inflammation in eosinophilic esophagitis (EoE). Unlike the standard treatments like dietary changes, proton pump inhibitors, or topical steroids, which address symptoms and inflammation indirectly, dupilumab directly interferes with the inflammatory pathways involved in EoE. Researchers are excited about dupilumab because it offers a targeted approach, potentially providing relief with fewer side effects and improving quality of life for patients with EoE.

What is the effectiveness track record for dupilumab in treating Eosinophilic Esophagitis?

Research has shown that dupilumab, the treatment under study in this trial, effectively treats eosinophilic esophagitis (EoE), a condition where certain white blood cells inflame the esophagus. Studies have found that dupilumab can reduce symptoms like difficulty swallowing and decrease the number of these inflammatory cells in the esophagus. In one study, patients experienced a noticeable decrease in symptoms and inflammation after using the treatment. Additionally, dupilumab improved the appearance of esophagus tissue under a microscope, making it look more normal. These findings suggest that dupilumab could be a promising option for people with EoE, possibly allowing them to eat foods that previously caused issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan M Spergel, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 4 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:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Genzyme, a Sanofi Company

Industry Sponsor

Trials

528

Recruited

186,000+

David Meeker

Genzyme, a Sanofi Company

Chief Executive Officer since 2011

MD from the University of Vermont Medical School, Advanced Management Program at Harvard Business School

Jean-Paul Kress

Genzyme, a Sanofi Company

Chief Medical Officer since 2015

MD from Faculte Necker-Enfants Malades, Paris

Citations

1. dupixenthcp.com dupixenthcp.com/eoe/efficacy-safety/efficacy

Efficacy in EoE | DUPIXENT® (dupilumab) Week 52b: -23.4-point reduction (76%) from baseline after 52 weeks of treatment with DUPIXENT (n=29) · Week 52b: -21.7-point reduction (66%) from baseline after

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998943/

Real-world Effectiveness of Dupilumab in Eosinophilic ... Clinical trials have shown its effectiveness in alleviating symptoms and decreasing inflammation associated with EoE. However, real-world data ...

3. gi.org gi.org/journals-publications/ebgi/eluri_dec2024/

Long Term Efficacy and Safety of Dupilumab for ... Weekly dupilumab significantly reduced dysphagia symptoms, with a mean DSQ score improvement of –30.3 points, and decreased peak eosinophil ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2205982

Dupilumab in Adults and Adolescents with Eosinophilic ... Among patients with eosinophilic esophagitis, subcutaneous dupilumab administered weekly improved histologic outcomes and alleviated symptoms of the disease.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11857325/

Efficacy of Dupilumab in the Treatment of Eosinophilic ... These findings suggest that DUPI is effective in promoting histologic remission in EoE, with LE-DUPI emerging as a preferred option for ...

6. dupixenthcp.com dupixenthcp.com/eoe/efficacy-safety/safety-data

EoE Safety Data | DUPIXENT® (dupilumab) Explore safety data from a clinical trial using DUPIXENT® (dupilumab) as a treatment option for eosinophilic esophagitis (EoE) in adult & adolescent ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04394351

NCT04394351 | Study to Investigate the Efficacy and ... To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE; To evaluate the ...

8. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2023/07/29964-Dupilumab-for-Eosinophilic-Oesophagitis-V1.0-MAY2023-NON-CONF.pdf

Health Technology Briefing May 2023 Dupilumab is in clinical development for the treatment of paediatric patients with active eosinophilic oesophagitis (EoE). EoE is an allergic ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02379052

NCT02379052 | Study of Dupilumab in Adult Participants ... To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult participants with active, moderate to severe EoE; To assess the effect ...

10. dupixent.com dupixent.com/eoe/

DUPIXENT® (dupilumab) For Eosinophilic Esophagitis DUPIXENT is the first. AND ONLY FDA-approved treatment of its kind for eosinophilic esophagitis (EoE). DUPIXENT is a Breakthrough Treatment for EoE.