Dupilumab for Eosinophilic Esophagitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new drug, dupilumab (an injectable medication), for children with eosinophilic esophagitis (EoE), a condition that makes eating and obtaining proper nutrition difficult. Researchers aim to determine if the drug reduces symptoms over 24 weeks and to identify any side effects. Children who have experienced EoE symptoms in the past month and have been diagnosed through specific tests may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken swallowed topical corticosteroids within 8 weeks before the study starts. It's best to discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that dupilumab is generally well-tolerated. In past studies with adults and teenagers, the most common side effect was a reaction at the injection site, occurring in about 14% of those receiving the treatment weekly. Fewer participants experienced reactions with a placebo, which contains no active medicine.
The safety profile of dupilumab was similar for both adults and adolescents aged 12 to 17 in these studies, indicating that the side effects and their frequency were consistent across age groups. Overall, dupilumab appears to be a promising treatment with manageable side effects.12345Why do researchers think this study treatment might be promising for EoE?
Researchers are excited about Dupilumab for treating Eosinophilic Esophagitis because it offers a new way to tackle the condition. Unlike traditional treatments like proton pump inhibitors and corticosteroids, which mainly address symptoms, Dupilumab targets the underlying inflammatory process by blocking the IL-4 and IL-13 pathways. This specific mechanism can potentially reduce inflammation more effectively and with fewer side effects. As a biologic medication, Dupilumab offers a promising alternative for patients who haven't found relief with existing therapies.
What evidence suggests that dupilumab might be an effective treatment for eosinophilic esophagitis?
Research has shown that dupilumab can reduce symptoms for people with eosinophilic esophagitis (EoE). It lessens the frequency and severity of swallowing difficulties, a common issue with EoE. In one study, patients reported significant improvement in their symptoms, indicating that dupilumab eases discomfort. Additionally, dupilumab reduces esophageal swelling, the main cause of EoE symptoms. Previous studies have demonstrated that dupilumab is safe and effective for children with EoE, offering hope for better management of this condition. This trial will evaluate different dosing regimens of dupilumab to determine the most effective approach for treating EoE.23678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for small children aged over 6 months and under 15 kg with active EoE, an allergic condition of the esophagus. They must have had symptoms in the month before screening and show certain levels of eosinophilic infiltration in their esophageal biopsies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug dupilumab for 24 weeks to evaluate safety, tolerability, and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
Trial Overview
The study tests dupilumab's safety, tolerability, and effectiveness over a period of 24 weeks in treating EoE. It also examines potential side effects, drug levels in blood at different times, and if the body creates antibodies against it.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
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
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Citations
Efficacy in EoE | DUPIXENT® (dupilumab)
DUPIXENT was studied across clinical, histologic, and endoscopic endpoints up to 52 weeks · DUPIXENT REDUCED THE FREQUENCY AND SEVERITY OF DYSPHAGIA SYMPTOMS ...
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 ...
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 ...
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.
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)
The safety profile of DUPIXENT was similar in Parts A and B between adults and 72 pediatric subjects aged 12 to 17 years, weighing ≥40 kg.
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.
NCT03633617 | Study to Determine the Efficacy and Safety ...
A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
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