The goal of this study is to research Dupilumab, an FDA approved medication in treating patients diagnosed with Eosinophilic esophagitis (EoE). The drug works by controlling allergic inflammation of the esophagus. The esophagus is a food pipe that transfers food from the mouth into the stomach. Participants with EoE have dysfunction of the muscle of the esophagus (impaired peristalsis) that is not favorable for the transport function.
Main question this study aims to answer is: Whether Dupilumab helps improve muscle activity of the esophagus in participants with EOE?
Participants will:
Take Dupilumab every week for 12 weeks. Visit the clinic before and after starting the medication. Keep a diary of symptoms.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study including regular follow-up with the study monitor.
Persons aged 22-75 years of age, males and females, of all ethnic races.
Participants must be diagnosed with PPI resistant eosinophilic esophagitis (EoE) (proven by endoscopic biopsy showing > 15 eosinophils/HPF prior to and 8 weeks after treatment with PPI) will be eligible to participate in the study.
Prior participation in a Dupilumab clinical trial, or past or current treatment with Dupilumab
Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Participants on a food-elimination diet must remain on the same diet throughout the study.
Other causes of esophageal eosinophilia for the following conditions: hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), Participants with eosinophilic gastroenteritis are eligible, provided they meet other eligibility criteria.
Active Helicobacter pylori infection, history of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
University of California, San Diego
Lead sponsor
Regeneron Pharmaceuticals
Collaborator