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DEGAS
This study is now recruiting.
The main objective of this study is to see if repeat subcutaneous doses of dupilumab, the study medicine, helps to reduce eosinophilic inflammation in the stomach of participants with eosinophilic gastritis/ eosinophilic gastroenteritis compared to a placebo. A placebo is a pill or substance that is given to a patient like a drug but that has no physical effect on the patient.
Who Do I Contact?
If you are interested in participating in the study or want to learn more please contact our study team at carbonara [at] chop.edu or 267-426-8603.
Eligibility & Criteria
IRB #:
21-018853
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4RA) in Subjects with Eosinophilic Gastritis (DEGAS)
Study Phase:
Phase I
Eligible Age Range:
12 - 21 Years
Gender:
All
Visit Criteria
The study involves the following:
Screening Period (up to 8 weeks): This period includes signing consent, answering medical history questions, and completing an endoscopy with biopsy for screening purposes.
Double-blind Treatment Phase (5 visits to clinic): This involves study injections at weeks 2, 4, 6, 8 and 10 and if you continue into the open-label extension period of the study, at week 12. You/your caregiver will be trained how to self-administer the study drug. At week 12, an endoscopy with biopsy will be performed.
Open-Label Extension Period: If you qualify, you will continue study medication for this part of the study. You will have three clinic visits and two telephone visits. This period involves dupilumab injectiosn, blood draws (weeks 4 & 16) and an endoscopy with biopsy at the final week 24 clinic visit.
Follow-Up Period: After you complete either the double blind study treatment phase or the open-label extension period of the study, you will be followed for 12 weeks. There will be a telephone visit and you will be asked how you've been feeling since the last dose of study drug or placebo.
Leader
