for people ages 12 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage.

The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in your blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Official 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


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


Eosinophilic Gastritis, Eosinophilic Duodenitis, Eosinophilic Gastrointestinal Disease, Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID), Gastritis, Gastrointestinal Diseases, Digestive System Diseases, Eosinophilic Esophagitis, Enteritis, Duodenitis, Eosinophilia, Monoclonal Antibodies, Dupilumab Dose 1, Dupilumab Dose 2


You can join if…

Open to people ages 12 years and up

  1. Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
  2. Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening
  3. Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
  4. Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit
  5. History (by patient report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening
  6. 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.

You CAN'T join if...

  1. Body weight less than 40 kg
  2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
  3. Helicobacter pylori infection
  4. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
  5. History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery
  6. Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome
  7. 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
  8. 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
  9. Planned or anticipated use of any prohibited medications and procedures during the study

    10. Planned or anticipated major surgical procedure during the study 11. Receiving tube feeding or parenteral nutritional at screening (Part A and B). NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply


  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Om Research LLC accepting new patients
    Lancaster California 93534 United States


accepting new patients
Start Date
Completion Date
Regeneron Pharmaceuticals
Welcome to Engage! Clinical research study for eosinophilic gastritis with or without eosinophilic duodenitis
Phase 2/3 research study
Study Type
Expecting 279 study participants
Last Updated