Phase 2
N=41
Dupilumab in Eosinophilic Gastritis
Eosinophilic Gastritis · Eosinophilic Gastroenteritis
Bottom Line
View on ClinicalTrials.gov: NCT03678545 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Relative Change of Peak Eosinophil Counts in the Stomach — -50.28; -3.54 Eosinophil per HPF (EOS/HPF)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dupilumab (blinded) (Drug); Placebo (blinded) (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change of Peak Eosinophil Counts in the Stomach |
-50.28; -3.54 | — |
Summary
40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.
Eligibility Criteria
Inclusion Criteria
- Participant and/or parent guardian must be able to understand and provide informed consent and/or assent.
- Willing and able to comply with study visits and activities
- Age ≥ 12 and 10 mg for any reason or steroid burst for > 3 days within 1 month of screening.
- Prior exposure to dupilumab.
- History of anaphylaxis to any biologic therapy.
- Current pregnancy or breastfeeding.
- Ocular disorder.
- Individuals who have required use of a systemic corticosteroid for asthma.
- Received live vaccine 30 days prior to screening or planning on receiving a live vaccine during the time period that he/she is participating in the study.
- Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope.
- History of bleeding disorders or esophageal varices.
- Active parasitic infection.
- History of alcohol or drug abuse within 6 months prior to screening.
- Participant or his/her immediate family is a member of the investigational team.
- Planned or anticipated major surgical procedure during the study.
- Initiation, discontinuation or addition of allergens to subcutaneous immunotherapy (SCIT) within 12 months prior to screening.
- Treatment with sublingual immunotherapy (SLIT) within 6 months prior to screening.
- Treatment with oral immunotherapy (OIT) within 6 months prior to screening.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals or antifungals within 2 weeks before the baseline visit
- Known or suspected immunodeficiency disorder, including human immunodeficiency disorder (HIV).
- Planned or anticipated use of any prohibited medications and procedures during the study.
- Initiation, discontinuation or change in the dosage regimen of the following Proton pump inhibitors (PPIs) Leukotriene inhibitors Nasal and/or inhaled corticosteroids
- Women of childbearing potential who are unwilling to practice highly effective contraception.
Data sourced from ClinicalTrials.gov (NCT03678545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.