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.
Who Can Participate?
Eligibility
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
Age Range
12-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
EFFICACY AND SAFETY OF DUPILUMAB IN ADULT AND
ADOLESCENT PATIENTS WITH EOSINOPHILIC GASTRITIS WITH
OR WITHOUT EOSINOPHILIC DUODENITIS
Principal Investigator
David
Leiman
Protocol Number
PRO00113649
NCT ID
NCT05831176
Phase
II/III
Enrollment Status
Open to Enrollment