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
Single group
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
DrugDosage form: Subcutaneous injection Dosage: 300 mg/ 2ml Dosage frequency: Once a week Duration: 12 weeks
To determine the change in the peak esophageal muscle thickness during peristalsis following 12 weeks of Dupilumab
To see if there is an improvement in the longitudinal muscle dysfunction - increase in the muscle thickness (difference between baseline and at the peak of swallow-induced esophageal contraction), and peak muscle thickness at the peak of circular muscle contraction, measured in millimeters will be recorded. The investigators will make paired observation in each participant, i.e., before and after treatment with Dupilumab, and perform paired t test statistics.
To determine the change in the esophageal luminal cross-sectional area ( measured in mm2) following treatment with Dupilumab
To see if there is an increase in the luminal cross-sectional area during peristalsis (measured in mm2) following treatment, which will be assessed by the impedance recording. The investigators expect a statistically significant increase in luminal cross-sectional area during peristalsis following treatment with Dupilumab.
To determine the differences in amplitude of longitudinal muscle contraction in EOE participants who have reduction in eosinophil count < 6 HPF, compared to the one with eosinophil count > 6HPF following 12 weeks treatment with Dupilumab
To measure whether there is a statistically significant difference in the amplitude of longitudinal muscle contraction (peak muscle thickness or the difference between baseline and peak muscle thickness measured in mm) between those EOE participants who have reduction in eosinophil count of \< 6 HPF, as compared to the one with eosinophil count of \> 6HPF, following 12 weeks of treatment with Dupilumab. Participants with eosinophils \< 6HPF should have greater improvement compared to participants with \>6 HPF
To determine the differences in the luminal CSA during peristalsis following 12 weeks of treatment with Dupilumab in EOE participants who have reduction in the eosinophil count of < 6 HPF as compared to the one with eosinophil count of > 6HPF.
To see if there is a statistically significant differences in the luminal CSA (measured in mm2) during peristalsis following 12 weeks of treatment with Dupilumab in those EOE participants who have reduction in the eosinophil count of \< 6 HPF as compared to the one with eosinophil count of \> 6HPF.
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University of California, San Diego
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
