New drug shows promise for rare stomach disease
NCT ID NCT03678545
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested dupilumab, a drug that calms certain immune reactions, in 41 people aged 12-70 with eosinophilic gastritis, a condition where too many immune cells build up in the stomach lining. Participants received either dupilumab or a placebo injection every two weeks for 12 weeks. The main goal was to see if the drug reduced stomach inflammation compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (a drug that blocks certain immune signals to reduce inflammation)
- What this could lead to
- If it works, this could point toward a treatment for eosinophilic gastritis, a rare stomach condition causing pain and swelling.
- What could go wrong
- This is a small, early-phase trial with only 41 people. The drug may not reduce stomach inflammation better than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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41 people
The number who actually took part.
- Started
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May 2021
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant and/or parent guardian must be able to understand and provide informed consent and/or assent. 2. Willing and able to comply with study visits and activities 3. Age ≥ 12 and \< 71 years at study enrollment 4. Histologically active EG at time of screening, with a peak gastric count of ≥ 30 eos/hpf in at least 5 hpfs in the gastric antrum and/or body. 5. History (by patient report) of moderate to severe EG symptoms 6. Stable medical management of EG. 7. Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy. 8. If have asthma and/or any other chronic allergic conditions they must be willing to maintain their pretrial medications until the end of study. Medication dose can be increased if there is a deterioration in the condition. 9. Score on Asthma Control Test (ACTTM) ≥ 20 Exclusion Criteria: 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol. 2. Current active H. pylori infection. 3. Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease. 4. Known or suspected active colitis in the Principal Investigator's opinion or by biopsy. 5. Hypereosinophilic syndrome. 6. History of cancer 7. Current or recent use of biological agents. 8. Leukocyte count has not returned to the relevant lower limit of normal after discontinuing cell depleting biological agents. 9. Current or recent use of any investigational drug. 10. Current use of systemic steroids with daily dose \> 10 mg for any reason or steroid burst for \> 3 days within 1 month of screening. 11. Prior exposure to dupilumab. 12. History of anaphylaxis to any biologic therapy. 13. Current pregnancy or breastfeeding. 14. Ocular disorder. 15. Individuals who have required use of a systemic corticosteroid for asthma. 16. 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. 17. Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope. 18. History of bleeding disorders or esophageal varices. 19. Active parasitic infection. 20. History of alcohol or drug abuse within 6 months prior to screening. 21. Participant or his/her immediate family is a member of the investigational team. 22. Planned or anticipated major surgical procedure during the study. 23. Initiation, discontinuation or addition of allergens to subcutaneous immunotherapy (SCIT) within 12 months prior to screening. 24. Treatment with sublingual immunotherapy (SLIT) within 6 months prior to screening. 25. Treatment with oral immunotherapy (OIT) within 6 months prior to screening. 26. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals or antifungals within 2 weeks before the baseline visit 27. Known or suspected immunodeficiency disorder, including human immunodeficiency disorder (HIV). 28. Planned or anticipated use of any prohibited medications and procedures during the study. 29. Initiation, discontinuation or change in the dosage regimen of the following Proton pump inhibitors (PPIs) Leukotriene inhibitors Nasal and/or inhaled corticosteroids 30. Women of childbearing potential who are unwilling to practice highly effective contraception.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Northwestern Medicine Digestive Health Center
Chicago, Illinois, 60611, United States
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Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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University of Colorado Denver and Hospital
Aurora, Colorado, 80045, United States
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University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Utah Hospital
Salt Lake City, Utah, 84132, United States
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