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

NCT05831176 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R668-EGE-22132022-500795-62-00
• Study Type: interventional
• Target: 22
• Locations: 4 countries
• Sites: 53

Brief 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)

Conditions

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

Keywords

Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD)

Outcome Measures

Primary Outcomes (1)

• Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)

  Baseline up to 24 Weeks

Secondary Outcomes (23)

• Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)

  Baseline up to 52 Weeks

• Proportion of participants achieving a peak gastric eosinophil count of ≤20 eos/hpf

  Up to 52 Weeks

• Proportion of participants achieving a peak gastric eosinophil count of ≤30 eos/hpf

  Up to 52 Weeks

• Proportion of participants achieving both a peak gastric eosinophil count of ≤20 eos/hpf and a peak duodenal eosinophil count of ≤30 eos/hpf

  Up to 52 Weeks

• Proportion of participants achieving a peak duodenal eosinophil count of ≤30 eos/hpf

  Up to 52 Weeks

Study Arms (1)

Dupilumab

EXPERIMENTAL

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

Drug: Dupilumab

Interventions

Dupilumab DRUG

Administered as described in the protocol

Also known as: DUPIXENT®, REGN668, SAR231893

Dupilumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Body weight less than 40 kg at screening
• Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
• Helicobacter pylori infection
• Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
• History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery, as defined in the protocol
• 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
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (53)

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Om Research LLC

Apple Valley, California, 92307, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

University of California - Los Angeles (UCLA)

Los Angeles, California, 90024, United States

Location

University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

Location

GastroIntestinal BioSciences

Los Angeles, California, 90067, United States

Location

United Medical Doctors

Murrieta, California, 92563, United States

Location

Ucsf Medical Center (Benioff Childrens Hospital)

San Francisco, California, 94158, United States

Location

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

Aurora, Colorado, 80045, United States

Location

Connecticut Clinical Research Institute

Bristol, Connecticut, 06010, United States

Location

UConn Health

Farmington, Connecticut, 06030, United States

Location

Encore Borland-Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University Of Kansas

Kansas City, Kansas, 66103, United States

Location

Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MNGI Digestive Health P.A.

Plymouth, Minnesota, 55446, United States

Location

Mayo Clinic Hospital Rochester

Rochester, Minnesota, 55905, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

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

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

ESI Medical Research, PLLC

Kinston, North Carolina, 28513, United States

Location

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

Cincinnati, Ohio, 45229, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

The Oregon Clinic - Gastroenterology East

Portland, Oregon, 97220, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

TDDC dba GI Alliance Research

Mansfield, Texas, 76063, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Seattle Children's Home Health Company

Seattle, Washington, 98105, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Stollery Children's Hospital - University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

AOOR Villa Sofia/Cervello

Palermo, Sicily, 90146, Italy

Location

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

Bari, 70124, Italy

Location

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

Milan, 20162, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina

Roma, 00186, Italy

Location

University of Rome - Pediatric Gastroenterology and Liver Unit

Rome, 00161, Italy

Location

Iizuka Hospital

Iizuka, Fukuoka, 820-8505, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Gifu, 503-8502, Japan

Location

Kure Kyosai Hospital

Kure, Hiroshima, 737-8505, Japan

Location

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Hyōgo, 670-8560, Japan

Location

Kobe University Graduate School of Medicine

Kobe, Hyōgo, 650-0017, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Kawasaki Medical School Hospital

Kurashiki, Okayama-ken, 701-0192, Japan

Location

Toranomon Hospital

Minato-ku, Tokyo, 105-8470, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Related Publications (1)

• Sia T, Bacchus L, Tanaka R, Khuda R, Mallik S, Leung J. Dupilumab Can Induce Remission of Eosinophilic Gastritis and Duodenitis: A Retrospective Case Series. Clin Transl Gastroenterol. 2024 Jan 1;15(1):e00646. doi: 10.14309/ctg.0000000000000646.

  PMID: 37753954 DERIVED

MeSH Terms

Conditions

Eosinophilic enteropathy; Eosinophilic Esophagitis

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 3, 2023
• Primary Completion: February 18, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

IT (7); US (36); CA (1); JP (9)