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Could an allergy drug tame rare stomach inflammation?

NCT ID NCT05831176

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests dupilumab, an injectable drug already used for allergies, in 22 adults and teens with eosinophilic gastritis (stomach inflammation caused by too many white blood cells). The goal is to see if it reduces inflammation and improves symptoms over 6 months to a year. It's an early, open-label trial, so results are promising but not yet proven.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent)
What this could lead to
If successful, this could point toward a new treatment option for eosinophilic gastritis, a rare stomach condition with limited therapies.
What could go wrong
This is a small, early-phase trial with only 22 participants and no placebo group, so results may not apply broadly. Side effects and long-term benefits are still unknown.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

22 people

The number who actually took part.

Started

May 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

duodenitis Eosinophilic enteropathy eosinophilic esophagitis eosinophilic gastritis eosinophilic gastroenteritis eosinophilic gastrointestinal disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic duodenitis (EOD) Eosinophilic gastritis (EOG) Eosinophilic gastroenteritis Eosinophilic gastrointestinal disease (EGID)

Contacts and locations

Locations

  • AOOR Villa Sofia/Cervello

    Palermo, Sicily, 90146, Italy

  • Advanced Research Institute

    Reno, Nevada, 89511, United States

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124, Italy

  • Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School

    Boston, Massachusetts, 02215, United States

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207, United States

  • Connecticut Clinical Research Institute

    Bristol, Connecticut, 06010, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • ESI Medical Research, PLLC

    Kinston, North Carolina, 28513, United States

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida, 32256, United States

  • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

    Milan, 20162, Italy

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • GastroIntestinal BioSciences

    Los Angeles, California, 90067, United States

  • Humanitas Research Hospital

    Rozzano, Milan, 20089, Italy

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo, 670-8560, Japan

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

    New York, New York, 10029, United States

  • Iizuka Hospital

    Iizuka, Fukuoka, 820-8505, Japan

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken, 701-0192, Japan

  • Kobe University Graduate School of Medicine

    Kobe, Hyōgo, 650-0017, Japan

  • Kure Kyosai Hospital

    Kure, Hiroshima, 737-8505, Japan

  • MNGI Digestive Health P.A.

    Plymouth, Minnesota, 55446, United States

  • Mayo Clinic Hospital Rochester

    Rochester, Minnesota, 55905, United States

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502, Japan

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Om Research LLC

    Apple Valley, California, 92307, United States

  • Om Research LLC

    Lancaster, California, 93534, United States

  • Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma, 00186, Italy

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Scripps Clinic

    La Jolla, California, 92037, United States

  • Seattle Children's Home Health Company

    Seattle, Washington, 98105, United States

  • Stollery Children's Hospital - University of Alberta

    Edmonton, Alberta, T6G 1C9, Canada

  • TDDC dba GI Alliance Research

    Mansfield, Texas, 76063, United States

  • The Oregon Clinic - Gastroenterology East

    Portland, Oregon, 97220, United States

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470, Japan

  • U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale

    Bari, 70124, Italy

  • UConn Health

    Farmington, Connecticut, 06030, United States

  • Ucsf Medical Center (Benioff Childrens Hospital)

    San Francisco, California, 94158, United States

  • United Medical Doctors

    Murrieta, California, 92563, United States

  • University Of Kansas

    Kansas City, Kansas, 66103, United States

  • University of California - Los Angeles (UCLA)

    Los Angeles, California, 90024, United States

  • University of Cincinnati Medical Center-Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rome - Pediatric Gastroenterology and Liver Unit

    Rome, 00161, Italy

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90033, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Yamagata University Hospital

    Yamagata, 990-9585, Japan

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.