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ACTIVE NOT RECRUITING

NCT05831176

PHASE2

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-05-03

Completion Date

2026-11-25

Last Updated

2025-10-08

Healthy Volunteers

Conditions

Eosinophilic Gastritis (EoG)Eosinophilic Duodenitis (EoD)Eosinophilic Gastrointestinal Disease (EGID)Eosinophilic Gastroenteritis

Interventions

DRUG

Dupilumab

Administered as described in the protocol

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

Locations (53)

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Om Research LLC

Apple Valley, California, United States

Scripps Clinic

La Jolla, California, United States

Om Research LLC

Lancaster, California, United States

University of California - Los Angeles (UCLA)

Los Angeles, California, United States

University of Southern California Keck School of Medicine

Los Angeles, California, United States

GastroIntestinal BioSciences

Los Angeles, California, United States

United Medical Doctors

Murrieta, California, United States

Ucsf Medical Center (Benioff Childrens Hospital)

San Francisco, California, United States

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

Aurora, Colorado, United States

Connecticut Clinical Research Institute

Bristol, Connecticut, United States

UConn Health

Farmington, Connecticut, United States

Encore Borland-Groover Clinical Research

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

University Of Kansas

Kansas City, Kansas, United States

Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

MNGI Digestive Health P.A.

Plymouth, Minnesota, United States

Mayo Clinic Hospital Rochester

Rochester, Minnesota, United States

Advanced Research Institute

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Northwell Health

Great Neck, New York, United States

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

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

ESI Medical Research, PLLC

Kinston, North Carolina, United States

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

Cincinnati, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

The Oregon Clinic - Gastroenterology East

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

TDDC dba GI Alliance Research

Mansfield, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Home Health Company

Seattle, Washington, United States

Froedtert Hospital

Milwaukee, Wisconsin, United States

Stollery Children's Hospital - University of Alberta

Edmonton, Alberta, Canada

Humanitas Research Hospital

Rozzano, Milan, Italy

AOOR Villa Sofia/Cervello

Palermo, Sicily, Italy

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

Bari, Italy

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

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina

Roma, Italy

University of Rome - Pediatric Gastroenterology and Liver Unit

Rome, Italy

Iizuka Hospital

Iizuka, Fukuoka, Japan

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Kure Kyosai Hospital

Kure, Hiroshima, Japan

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Hyōgo, Japan

Kobe University Graduate School of Medicine

Kobe, Hyōgo, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Kawasaki Medical School Hospital

Kurashiki, Okayama-ken, Japan

Toranomon Hospital

Minato-ku, Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)