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

Last updated: June 29, 2026
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gastroenteritis

Heartburn

Duodenal Ulcers

Treatment

Matching Placebo

Dupilumab

Dupilumab Dose 2

Clinical Study ID

NCT05831176
R668-EGE-2213
2022-500795-62-00
  • Ages > 12
  • All Genders

Study Summary

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.

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)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Adolescent participants will only be enrolled at study sites in countries/regions aspermitted by local regulatory authorities and ethic committees (ECs)

  2. Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilicgastritis (EoG) at least 3 months prior to screening

  3. Screening endoscopic biopsies with a demonstration of eosinophilic infiltration fora 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 weeksprior 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 perweek for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scaleof 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6symptoms, as defined in the protocol.

Exclusion

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 withdupilumab

  3. Helicobacter pylori infection

  4. Any esophageal stricture unable to be passed with a standard, diagnostic, upperendoscope 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 followingconditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)or hyper-eosinophilic syndrome

  7. History of bleeding disorders, esophageal or gastric varices that, in the opinion ofthe investigator, would put the participant at undue risk for significantcomplications from an endoscopy procedure

  8. Initiation or change of a food-elimination diet regimen or re-introduction of apreviously 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 thestudy

  9. Planned or anticipated use of any prohibited medications and procedures during thestudy

  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

Study Design

Total Participants: 22
Treatment Group(s): 4
Primary Treatment: Matching Placebo
Phase: 2
Study Start date:
May 03, 2023
Estimated Completion Date:
November 25, 2026

Study Description

This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants

  • Part A is an open-label treatment period lasting up to 24 weeks (up to 6 months). "Open-label" means that you and the study doctors and the staff staff will know that you are taking the study drug

  • Part C is an open-label extended treatment period lasting up to 28 weeks (about 7 months). "Extended Treatment Period" means that you will take the study drug for an additional 28 weeks after finishing Part A if you are eligible to take part in this part of the study

Connect with a study center

  • Nepean Clinical School

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • Mater Research Ltd

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Stollery Children's Hospital - University of Alberta

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • University Of Alberta

    Edmonton, Alberta T6G 1Z1
    Canada

    Active - Recruiting

  • Humanitas Research Hospital

    Rozzano, Milan 20089
    Italy

    Site Not Available

  • AOOR Villa Sofia/Cervello

    Palermo, Sicily 90146
    Italy

    Site Not Available

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

    Bari, 70124
    Italy

    Site Not Available

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

    Milan, 20162
    Italy

    Site Not Available

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Ospedali Riuniti Villa Cervello

    Palermo, 90146
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma, 00186
    Italy

    Site Not Available

  • Sapienza - University of Rome

    Rome, 00161
    Italy

    Active - Recruiting

  • University of Rome - Pediatric Gastroenterology and Liver Unit

    Rome, 00161
    Italy

    Site Not Available

  • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Iizuka Hospital

    Iizuka, Fukuoka 820-8505
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Ōgaki, Gifu 503-8502
    Japan

    Site Not Available

  • Kure Kyosai Hospital

    Kure, Hiroshima 737-8505
    Japan

    Site Not Available

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo 670-8560
    Japan

    Site Not Available

  • Kobe University Graduate School of Medicine

    Kobe, Hyōgo 650-0017
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Yokohama, Kanagawa 236-0004
    Japan

    Site Not Available

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken 701-0192
    Japan

    Site Not Available

  • Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital

    Minato-ku, Tokyo 105-8470
    Japan

    Active - Recruiting

  • Toranomon Hospital

    Minato-ku, Tokyo 105-8470
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • Centrum Medyczne Melita Medical

    Wroclaw, 50449
    Poland

    Active - Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Om Research LLC

    Apple Valley, California 92307
    United States

    Site Not Available

  • Scripps Clinic

    La Jolla, California 92037
    United States

    Site Not Available

  • Om Research LLC

    Lancaster, California 93534
    United States

    Site Not Available

  • GastroIntestinal BioSciences

    Los Angeles, California 90067
    United States

    Site Not Available

  • USC, Keck School of Medicine

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of California - Los Angeles (UCLA)

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of Southern California Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • United Medical Doctors

    Murrieta, California 92563
    United States

    Site Not Available

  • Ucsf Medical Center (Benioff Childrens Hospital)

    San Francisco, California 94158
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Scripps Memorial Hospital La Jolla

    La Jolla 5363943, California 5332921 92037
    United States

    Active - Recruiting

  • GastroIntestinal BioSciences

    Los Angeles 5368361, California 5332921 90067
    United States

    Site Not Available

  • University of California - Los Angeles (UCLA)

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of Southern California Keck School of Medicine

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

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

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Connecticut Clinical Research Institute

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • UConn Health

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • GI Alliance - Gurnee

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • University Of Kansas

    Kansas City, Kansas 66103
    United States

    Site Not Available

  • Meritus Center for Clinical Research

    Hagerstown, Maryland 21742
    United States

    Site Not Available

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

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Boston Specialists

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

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

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • MNGI Digestive Health P.A.

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Hospital Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Minnesota Gastroenterology, P.A.

    Plymouth 5041926, Minnesota 5037779 55446
    United States

    Active - Recruiting

  • Children's Hospital & Medical Center

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Advanced Research Institute

    Reno, Nevada 89511
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group

    Great Neck, New York 11023
    United States

    Site Not Available

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Site Not Available

  • Northwell Health

    Great Neck 5119218, New York 5128638 11021
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • ESI Medical Research, PLLC

    Kinston, North Carolina 28513
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 275997080
    United States

    Active - Recruiting

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

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Ohio State Univeristy Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • The Oregon Clinic - Gastroenterology East

    Portland, Oregon 97220
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • GI Alliance

    Garland, Texas 75044
    United States

    Site Not Available

  • Laredo Medical Center

    Laredo, Texas 78041
    United States

    Site Not Available

  • TDDC dba GI Alliance Research

    Mansfield, Texas 76063
    United States

    Site Not Available

  • The University of Utah Health Sciences Center

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Seattle Allergy and Asthma Research Institute

    Seattle, Washington 98115
    United States

    Site Not Available

  • Seattle Children's Home Health Company

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Allergy and Asthma Research Institute

    Seattle 5809844, Washington 5815135 98115
    United States

    Site Not Available

  • Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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