Eohilia + Dupixent for Eosinophilic Esophagitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares the effects of two treatments, Eohilia (budesonide, an oral corticosteroid) and Dupixent (dupilumab, an injectable medication), on the esophagus in people with eosinophilic esophagitis. This condition involves a buildup of white blood cells in the esophagus, causing narrowing and scarring. Researchers aim to assess how each treatment affects the size and scarring of the esophagus. Participants will receive either a weekly injection of Dupixent or a twice-daily oral suspension of Eohilia. The trial is suitable for individuals with a confirmed diagnosis of eosinophilic esophagitis who can manage regular medication and adhere to the study's schedule. As an Early Phase 1 trial, this research seeks to understand how these treatments work in people, offering participants the chance to contribute to groundbreaking medical knowledge.
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 participate if you've used prednisone within 2 months before the study or are on certain biologic therapies or medium/high potency topical steroids.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier research found dupilumab (Dupixent) to be safe for people with eosinophilic esophagitis (EoE). In one study, all participants who took it weekly showed positive results after a year. Another study found that dupilumab was well-tolerated by both adults and children, with no major safety concerns.
For budesonide (Eohilia), research has shown it is safe for long-term use. Studies found that when taken as a liquid, it helped many people with EoE without causing serious side effects. The FDA has approved budesonide for treating EoE, indicating its safety.
Both treatments have undergone testing in other studies with positive safety results. Always consult a healthcare professional to understand what this means for individual circumstances.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Eohilia (budesonide) and Dupixent (dupilumab) for treating eosinophilic esophagitis because these treatments offer novel approaches to managing this condition. Unlike traditional therapies that mainly involve dietary changes and corticosteroids, Dupixent is a biologic that targets the IL-4 and IL-13 pathways, reducing inflammation in a more targeted way. On the other hand, Eohilia provides a localized treatment via an oral suspension, allowing for direct application to the affected esophagus, potentially enhancing effectiveness and minimizing systemic side effects. Together, these treatments could offer more precise and effective relief for patients with this chronic inflammatory condition.
What evidence suggests that this trial's treatments could be effective for Eosinophilic Esophagitis?
This trial will compare the effectiveness of Dupixent (dupilumab) and Eohilia (budesonide) in treating eosinophilic esophagitis (EoE). Research has shown that Dupixent improves symptoms in about 89% of patients and significantly reduces eosinophils (a type of white blood cell) in the esophagus. It also helps increase the esophagus's size, which is crucial for EoE management. Meanwhile, Budesonide has effectively controlled the disease for up to 96 weeks, significantly reducing esophageal inflammation and easing swallowing. Both treatments have shown promising results in managing EoE symptoms.23678
Who Is on the Research Team?
Diana Snyder, M.D.
Principal Investigator
Mayo Clinic
Jennifer Horsley-Silva, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults (18+) diagnosed with eosinophilic esophagitis, weighing at least 40 kg, willing to take weekly injections or oral medication and follow study procedures. People can't join if they're pregnant, have certain autoimmune diseases, prior esophageal surgery, severe liver disease, or allergies to the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either dupilumab (300 mg weekly injection) or budesonide oral suspension (2mg twice daily) for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide
- Dupilumab
Trial Overview
The study compares two treatments for eosinophilic esophagitis: Eohilia (oral budesonide) and Dupixent (dupilumab injection), looking at their effects on the width and scarring of the esophagus. Participants are randomly assigned to one treatment group.
How Is the Trial Designed?
2
Treatment groups
Active Control
300 mg weekly injection
2mg twice daily
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Vanderbilt University Medical Center
Collaborator
Citations
Efficacy and safety of budesonide for eosinophilic esophagitis
Budesonide therapy has been shown to maintain clinical and histological remission for up to 96 weeks in long-term investigations, with no new ...
Long-term Safety and Efficacy of Budesonide Oral ...
Budesonide oral suspension improves outcomes in patients with eosinophilic esophagitis: results from a phase 3 trial. Clin Gastroenterol ...
Effectiveness and Safety of Orodispersible Budesonide for ...
Our real-world data confirm that BOTs are effective in inducing clinical and histologic remission in most EoE patients. The drug has a good safety profile, with ...
Clinical Efficacy - U.S. HCPs
Demonstrated improvement vs placebo in esophageal inflammation and dysphagia relief ... Mean (SD) peak eosinophil counts at baseline were 74.5 (39.2) eos/hpf and ...
Efficacy and safety of budesonide for eosinophilic ...
Budesonide significantly improved histologic remission (RR: 26.85; 95% CI: 13.72-52.56; P < 0.00001) and reduced peak eosinophil counts (SMD: - ...
Pooled Phase 2 and 3 Efficacy and Safety Data on ... - PMC
The objective of this study was to evaluate the efficacy and safety of budesonide oral suspension (BOS) in adolescents with eosinophilic esophagitis (EoE).
Efficacy & Safety Overview - U.S. HCPs
Overview of the efficacy & safety of EOHILIA™ (budesonide oral suspension) in eosinophilic esophagitis (EoE) patients 11 years and older.
EOHILIA (budesonide oral suspension) - accessdata.fda.gov
Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline ...
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