Regeneron_R668-EGE-2213 (Eosinophilic Gastritis [EoG]) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called dupilumab can help reduce inflammation in the stomach and small intestines for adults or children who are diagnosed with EoG.
What is the Condition Being Studied?
Eosinophilic Gastritis (EoG)
Who Can Participate in the Study?
Adults and children ages 12+ who:
- Are diagnosed with EoG
- Have their diagnosis confirmed by endoscopy
- Are experiencing symptoms of EoG like stomach cramping, stomach pain, nausea, bloating, early satiety (feeling "full" too soon after eating), or loss of appetite
- Do not have a history of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, Churg-Strauss syndrome, hyper-eosinophilic syndrome, or prior gastric or duodenal surgery
For more information, contact the study team at nicole.pavlus@duke.edu.
Age Group
Adults
What is Involved?
If you or your child choose to join the study, you/they will get a random assignment (by chance0 to either take the study drug or a placebo (inactive substance that has no drug in it).
Regardless of assignment, you/they will:
- Visit our clinic about 20 times over the course of 64 months
- Have physical exams
- Have blood draws
- Have endoscopies and biopsies
Study Details
Full Title
A PHASE 2/3, RANDOMIZED, 3-PART STUDY TO INVESTIGATE THE
EFFICACY AND SAFETY OF DUPILUMAB IN ADULT AND
ADOLESCENT PATIENTS WITH EOSINOPHILIC GASTRITIS WITH
OR WITHOUT EOSINOPHILIC DUODENITIS
Principal Investigator
Gastroenterologist
Protocol Number
IRB:
PRO00113649
NCT:
NCT05831176
Phase
Phase
II/III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment