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Phase 2 N=41 Randomized Triple-blind Treatment

Dupilumab in Eosinophilic Gastritis

Eosinophilic Gastritis · Eosinophilic Gastroenteritis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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