300 Participants Needed

Dupilumab for Eosinophilic Esophagitis

(EDESIA Trial)

Recruiting at 54 trial locations
CT
Overseen ByClinical Trials Administrator
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Regeneron Pharmaceuticals
Must be taking: Dupixent
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the use of DUPIXENT® (dupilumab) in everyday care for individuals with eosinophilic esophagitis (EoE), a condition that causes difficulty swallowing due to esophageal inflammation. Researchers will gather information on how EoE impacts symptoms, daily life, and overall quality of life through patient questionnaires. The trial seeks individuals who have recently begun treatment with DUPIXENT® for EoE and can complete the questionnaires. As a Phase 4 trial, this research helps determine how this FDA-approved and effective treatment benefits more patients.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for DUPIXENT® in treating eosinophilic esophagitis?

Research has shown that DUPIXENT® (dupilumab) is generally safe for people with eosinophilic esophagitis (EoE). The most common side effect is a reaction at the injection site, which might cause redness or itching. Importantly, recent studies have not identified any new safety concerns, which supports its use in treating EoE. Overall, current research considers DUPIXENT® safe.12345

Why are researchers excited about this trial?

DUPIXENT® is unique because it targets eosinophilic esophagitis (EoE) by blocking the action of interleukin-4 and interleukin-13, key proteins involved in the inflammatory response that causes EoE symptoms. Unlike traditional treatments like corticosteroids and proton pump inhibitors, which primarily focus on managing symptoms, DUPIXENT® directly addresses the underlying inflammation. Researchers are excited about this treatment because it offers a novel approach to managing EoE, potentially leading to better long-term outcomes and improved quality of life for patients.

What is the effectiveness track record for DUPIXENT® in treating eosinophilic esophagitis (EoE)?

This trial will evaluate the effectiveness of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE). Studies have shown that Dupixent effectively treats EoE, a condition affecting the esophagus. Specifically, research found that after 52 weeks of treatment, patients experienced a significant reduction in symptoms, with scores dropping by about 76% from the start. Dupixent also made swallowing easier and reduced esophageal inflammation. Another study showed an average improvement of 30.3 points in symptom scores, greatly easing the discomfort and challenges of EoE. These findings suggest that Dupixent can potentially improve the quality of life for those dealing with this condition.23678

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

I am starting treatment with DUPIXENT® for EoE as per guidelines.
I can understand and fill out study questionnaires.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DUPIXENT® as part of their standard care for eosinophilic esophagitis

Follow-up

Participants are monitored for changes in EoE symptoms and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dupilumab

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: EoE Patients treated with DUPIXENT®Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

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

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 ...

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.

4.

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 ...

Dupixent® (dupilumab) Phase 3 Results show sustained ...

Data from this Phase 3 trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is ...

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37660704/

Efficacy and safety of dupilumab up to 52 weeks in ... - PubMed

We aimed to assess its long-term efficacy and safety in adults and adolescents with eosinophilic oesophagitis enrolled in part B of the LIBERTY EoE TREET study.

Press Release: Dupixent® (dupilumab) Phase 3 trial ...

Dupixent® (dupilumab) Phase 3 trial shows positive results in children 1 to 11 years of age with eosinophilic esophagitis.