Overview
This trial will have 3 parts plus screening and follow-up parts: - Parts A and B: Participants will either be included in part A or B. Each is a 24-week double-blind (this means none of the participants, doctors, or other trial staff will know what treatment each participant took) part where participants will receive either dupilumab or a placebo (a placebo looks like a trial drug but does not have any medicine in it). - Part C: 28-week extension part that will include participants from parts A and B and all participants will receive dupilumab
Principal investigator
Eligibility criteria
Key Inclusion Criteria:
- Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
- Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening
- Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
- Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit
- History (by patient report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening
- For the 2 weeks prior to baseline visit, an average total symptom score (TSS) of at least of 20 calculated using data from the EoG/EoD-SQ eDiary and an average severity score of at least 4 (on a scale of 0-10) per week for at least 2 of the 6 symptoms, as defined in the protocol.
Key Exclusion Criteria:
- Body weight less than 40 kg
- Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
- Helicobacter pylori infection
- Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
- History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery
- Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome
- History of bleeding disorders, esophageal or gastric varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure
- Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 4 weeks prior to the screening visit. Participants on a food-elimination diet must remain on the same diet throughout the study
- Planned or anticipated use of any prohibited medications and procedures during the study
- Planned or anticipated major surgical procedure during the study
- Receiving tube feeding or parenteral nutritional at screening (Part A and B).
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Participate in this trial
Are you interested in enrolling in this study? Learn more here.
I'm Interested In ParticipatingFor Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.