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Evaluating Dupilumab for Eosinophilic Gastritis in Adults and Adolescents

A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Phase 2 Interventional Regeneron Pharmaceuticals · NCT05831176

This study is testing if the drug dupilumab can help adults and teens with eosinophilic gastritis feel better and reduce inflammation.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment22 (estimated)
Ages12 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsdupilumab
Locations79 sites (Phoenix, Arizona and 78 other locations)
Trial IDNCT05831176 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of dupilumab, an experimental drug, in treating eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD) in adults and adolescents aged 12 years and older. The trial consists of two parts: an initial open-label treatment period lasting up to 24 weeks, followed by an extended treatment period of up to 28 weeks for eligible participants. Researchers will assess symptom relief, inflammation reduction, potential side effects, and drug levels in the blood throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates include adolescents and adults diagnosed with eosinophilic gastritis, who have experienced frequent symptoms and meet specific inclusion criteria.

Not a fit: Patients with eosinophilic duodenitis only, without eosinophilic gastritis, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from eosinophilic gastritis and related conditions.

How similar studies have performed: While there have been studies on eosinophilic gastrointestinal diseases, the specific use of dupilumab for eosinophilic gastritis is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

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. Screening 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 participant report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening, as defined in the protocol
6. An average TSS of ≥ 20 calculated using data collected via the EoG/EoD-SQ eDiary per week for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scale of 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6 symptoms, as defined in the protocol.

Key Exclusion Criteria:

1. Body weight less than 40 kg at screening
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, as defined in the protocol
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

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Where this trial is running

Phoenix, Arizona and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic GastritisEosinophilic DuodenitisEosinophilic Gastrointestinal DiseaseEosinophilic GastroenteritisEosinophilic Gastritis with or without Eosinophilic Duodenitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.