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Active, not recruitingPhase 2

A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Ann Arbor, Apple Valley, Aurora, Boston, Bristol, Chapel Hill, Charlotte, Chicago, Cincinnati, Columbus, Durham, Farmington, Great Neck, Jacksonville, Kansas City, Kinston, La Jolla, Lancaster, Lebanon, Los Angeles, Mansfield, Milwaukee, Murrieta, New York, Oklahoma City, Philadelphia, Phoenix, Plymouth, Portland, Reno, Rochester, Salt Lake City, San Francisco, and Seattle, United StatesSee the 36 sitesAlso in 3 other countries, 17 sites
Status
Active, not recruiting
Phase
Phase 2
People taking part
22 people enrolled
Started
3 May 2023
Expected to end
25 Nov 2026
Type of study
Interventional
Treatments tested
  • Dupilumab
Record updated
1 July 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
  • Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening
  • Screening endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
  • Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit
  • 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
  • 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

Who cannot take part

  • Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
  • History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery, as defined in the protocol
  • 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
  • Planned or anticipated use of any prohibited medications and procedures during the study
  • Planned or anticipated major surgical procedure during the study
  • Receiving tube feeding or parenteral nutritional at screening; NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
  • Helicobacter pylori infection
  • Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome
  • 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
  • Body weight less than 40 kg at screening
  • Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening

Where in United States

Also in 3 other countries, 17 sites

  • University of MichiganAnn Arbor, United States
  • Om Research LLCApple Valley, United States
  • University of Colorado Anschutz Health Science Building (AHSB) CU Research PharmacyAurora, United States
  • Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical SchoolBoston, United States
  • Connecticut Clinical Research InstituteBristol, United States
  • University of North Carolina at Chapel HillChapel Hill, United States
  • Charlotte Gastroenterology & Hepatology, PLLCCharlotte, United States
  • Northwestern UniversityChicago, United States
  • University of Cincinnati Medical Center-Children's Hospital Medical CenterCincinnati, United States
  • Ohio State University Medical CenterColumbus, United States
  • Duke UniversityDurham, United States
  • UConn HealthFarmington, United States
  • Northwell HealthGreat Neck, United States
  • ENCORE Borland Groover Clinical ResearchJacksonville, United States
  • University of KansasKansas City, United States
  • ESI Medical Research, PLLCKinston, United States
  • Scripps ClinicLa Jolla, United States
  • Om Research LLCLancaster, United States
  • Dartmouth Hitchcock Medical CenterLebanon, United States
  • GastroIntestinal BioSciencesLos Angeles, United States
  • University of California Los Angeles (UCLA).Los Angeles, United States
  • University of Southern California Keck School of MedicineLos Angeles, United States
  • TDDC dba GI Alliance ResearchMansfield, United States
  • Froedtert HospitalMilwaukee, United States
  • United Medical DoctorsMurrieta, United States
  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)New York, United States
  • Allergy Asthma and Clinical Research CenterOklahoma City, United States
  • University of PennsylvaniaPhiladelphia, United States
  • Phoenix Childrens HospitalPhoenix, United States
  • MNGI Digestive Health, P.A.Plymouth, United States
  • The Oregon Clinic Gastroenterology-EastPortland, United States
  • Advanced Research InstituteReno, United States
  • Mayo Clinic Hospital - RochesterRochester, United States
  • University of UtahSalt Lake City, United States
  • Ucsf Medical Center (Benioff Childrens Hospital)San Francisco, United States
  • Seattle Children's Home Health CompanySeattle, United States

About the trial

What the trial wants to find out

This 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.

Read full original descriptionShow less

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 after at least 24 weeks (about 6 months) and up to 52 weeks (1 year) of treatment.

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 the 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)

The group in the trial

  • DupilumabTreatment being tested

    Part A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Publications
Record updated
1 July 2026