A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Last updated: January 28, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2/3

Condition

Infectious Colitis

Colic

Ulcers

Treatment

Matching Placebo

Dupilumab Dose 2

Dupilumab Dose 1

Clinical Study ID

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

Study Summary

The 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, compared to placebo.

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 your 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. Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for adiagnosis 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 patient report) of at least 2 episodes of EoG (with or without EoD)symptoms per week in 8 weeks before screening

  6. For the 2 weeks prior to baseline visit, an average total symptom score (TSS) of atleast of 20 calculated using data from the EoG/EoD-SQ eDiary and an average severityscore of at least 4 (on a scale of 0-10) per week for at least 2 of the 6 symptoms,as defined in the protocol.

Exclusion

Key Exclusion Criteria:

  1. Body weight less than 40 kg

  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

  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 (Part A and B).

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study Design

Total Participants: 279
Treatment Group(s): 3
Primary Treatment: Matching Placebo
Phase: 2/3
Study Start date:
May 03, 2023
Estimated Completion Date:
August 19, 2027

Study Description

This trial will have 3 parts plus screening and follow-up parts:

  • Parts A and B: Participants will either be included in part A or B. Each is a 24-week double-blind (this means none of the participants, doctors, or other trial staff will know what treatment each participant took) part where participants will receive either dupilumab or a placebo (a placebo looks like a trial drug but does not have any medicine in it).

  • Part C: 28-week extension part that will include participants from parts A and B and all participants will receive dupilumab

Connect with a study center

  • Nepean Clinical School

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • Mater Research Ltd

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • The University of Queensland - Princess Alexandra Hospital (PAH)

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • St. Vincent's Hospital

    Fitzroy, 3065
    Australia

    Site Not Available

  • Joondalup Health Campus

    Joondalup, 6027
    Australia

    Site Not Available

  • Coral Sea Clinical Research Institute

    North Mackay, 4740
    Australia

    Site Not Available

  • University Of Alberta

    Edmonton, Alberta T6G 1Z1
    Canada

    Active - Recruiting

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

    Bari, 70124
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • 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

    Active - Recruiting

  • Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma, 00186
    Italy

    Active - Recruiting

  • Sapienza - University of Rome

    Rome, 00161
    Italy

    Active - Recruiting

  • Humanitas Research Hospital

    Rozzano, 20089
    Italy

    Active - Recruiting

  • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Iizuka Hospital

    Iizuka, Fukuoka 820-8505
    Japan

    Active - Recruiting

  • Aso Iizuka Hospital

    Iizuka-shi, Fukuoka 820-8502
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Ogaki, Gifu 503-8502
    Japan

    Active - Recruiting

  • Isesaki Municipal Hospital

    Isesaki-shi, Gunma 372-0817
    Japan

    Active - Recruiting

  • Kure Kyosai Hospital

    Kure-shi, Hiroshima 737-8505
    Japan

    Active - Recruiting

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyogo 670-8560
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe-shi, Hyogo 650-0017
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Yokohama-shi, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama 701-0192
    Japan

    Active - Recruiting

  • Kawasaki Medical School Hospital

    Kurashiki City, Okayama 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

  • Yamagata University Hospital

    Yamagata-shi, Yamagata 990-9585
    Japan

    Active - Recruiting

  • Wip Warsaw Ibd Point Profesor Kierkus

    Warszawa, Mazowieckie 00-728
    Poland

    Active - Recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728
    Poland

    Site Not Available

  • Centrum Medyczne Melita Medical

    Wroclaw, 50449
    Poland

    Active - Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Om Research LLC

    Apple Valley, California 92307
    United States

    Active - Recruiting

  • Scripps Memorial Hospital La Jolla

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Om Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • United Gastroenterologists

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • GastroIntestinal BioSciences

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • USC, Keck School of Medicine

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • United Medical Doctors

    Murrieta, California 92563
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Connecticut Clinical Research Institute

    Bristol, Connecticut 06010
    United States

    Active - Recruiting

  • Uconn Health

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • GI Alliance - Gurnee

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • The University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University Of Kansas

    Kansas City, Kansas 66103
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Boston Specialists

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota 55446
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Children's Hospital & Medical Center

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Advanced Research Institute

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756-0001
    United States

    Active - Recruiting

  • Long Island Gastrointestinal Research Group

    Great Neck, New York 11023
    United States

    Site Not Available

  • Northwell Health

    Great Neck, New York 11021
    United States

    Active - Recruiting

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

    New York, New York 10029
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Duke University Health System

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • ESI Medical Research, PLLC

    Kinston, North Carolina 28513
    United States

    Active - Recruiting

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

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Ohio State Univeristy Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • The Oregon Clinic - Gastroenterology East

    Portland, Oregon 97220
    United States

    Active - Recruiting

  • 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

  • Galen Medical Group

    Hixson, Tennessee 37343
    United States

    Site Not Available

  • Vanderbilt University Medical Center-Digestive Disease Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • The University of Utah Health Sciences Center

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • Velocity Clinical Research

    West Jordan, Utah 84088
    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

    Active - Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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