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 (ENGAGE)

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Gastroenteritis; Eosinophilic Gastritis (EoG); Eosinophilic Duodenitis (EoD); Eosinophilic Gastrointestinal Disease (EGID)
• Intervention / Treatment: Drug: Dupilumab

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C9
      • Stollery Children's Hospital - University of Alberta
• Italy
  • Bari, Italy, 70124
    • U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
  • Milan, Italy, 20162
    • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00186
    • Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
  • Rome, Italy, 00161
    • University of Rome - Pediatric Gastroenterology and Liver Unit
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Humanitas Research Hospital
  • Sicily
    • Palermo, Sicily, Italy, 90146
      • AOOR Villa Sofia/Cervello
• Japan
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8505
      • Iizuka Hospital
  • Gifu
    • Ōgaki, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-8505
      • Kure Kyosai Hospital
  • Hyōgo
    • Himeji, Hyōgo, Japan, 670-8560
      • Hyogo Prefectural Harima-Himeji General Medical Center
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Graduate School of Medicine
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 701-0192
      • Kawasaki Medical School Hospital
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8470
      • Toranomon Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Childrens Hospital
  • California
    • Apple Valley, California, United States, 92307
      • Om Research LLC
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Los Angeles, California, United States, 90033
      • University of Southern California Keck School of Medicine
    • Los Angeles, California, United States, 90067
      • GastroIntestinal BioSciences
    • Los Angeles, California, United States, 90024
      • University of California - Los Angeles (UCLA)
    • Murrieta, California, United States, 92563
      • United Medical Doctors
    • San Francisco, California, United States, 94158
      • Ucsf Medical Center (Benioff Childrens Hospital)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Institute
    • Farmington, Connecticut, United States, 06030
      • UConn Health
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Encore Borland-Groover Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • MNGI Digestive Health P.A.
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Hospital Rochester
  • Nevada
    • Reno, Nevada, United States, 89511
      • Advanced Research Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology & Hepatology, PLLC
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Kinston, North Carolina, United States, 28513
      • ESI Medical Research, PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Medical Center-Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma and Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic - Gastroenterology East
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Mansfield, Texas, United States, 76063
      • TDDC dba GI Alliance Research
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Home Health Company
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab; Part A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C	Drug: Dupilumab; Administered as described in the protocol; Other Names: REGN668; SAR231893; DUPIXENT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)	Baseline up to 24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed for only those with duodenal involvement	Up to 52 Weeks
Absolute change in the EoG/EoD-SQ Total Symptom Score (TSS)	EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.	Baseline up to 52 Weeks
Percent change in the EoG/EoD-SQ TSS		Baseline up to 52 Weeks
Percent change in peak duodenal tissue eosinophil count (eos/hpf)	Assessed for only those with duodenal involvement	Baseline up to 52 Weeks
Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)	EoGHSS scores evaluate 11 features of gastric tissue. Total score is the sum of features scores divided by the maximum possible score for the biopsy. Total scores range from 0 - 1.	Baseline up to 52 Weeks
Change in frequency of diarrhea episodes	Assessed for only those with diarrhea at baseline	Baseline up to 52 Weeks
Change in frequency of vomiting episodes	Assessed for only those with vomiting at baseline	Baseline up to 52 Weeks
Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature	Assessed on gastric tissue Normalized Enrichment Score (NES) reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.	Baseline up to 52 Weeks
Change in the NES for the type 2 inflammation transcriptome signature	Assessed on duodenal tissue from participants with EoD NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.	Baseline up to 52 Weeks
Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature	Assessed on gastric tissue NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.	Baseline up to 52 Weeks
Proportion of participants who receive rescue medications or procedures		Up to 52 Weeks
Incidence of treatment-emergent adverse events (TEAEs)	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 52 Weeks
Incidence of treatment-emergent serious adverse events (SAEs)	An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger); Is life-threatening; Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Is an important medical event	Up to 52 Weeks
Incidence of treatment-emergent adverse events of special interest (AESIs)	An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it	Up to 52 Weeks
Incidence of TEAEs leading to permanent discontinuation of study treatment	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 52 Weeks
Incidence of anti-drug antibody (ADA)	Immunogenicity will be characterized per drug molecule by ADA status	Up to 52 Weeks
Titer of ADA	Immunogenicity will be characterized per drug molecule by ADA status	Up to 52 Weeks
Incidence of neutralizing antibody (NAb) to dupilumab	Immunogenicity will be characterized per drug molecule by NAb status	Up to 52 Weeks
Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)		Baseline up to 52 Weeks
Concentrations of functional dupilumab in serum at each assessment time point	The concentrations of functional dupilumab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.	Baseline up to 64 Weeks

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Helpful Links

• Welcome to Engage! Clinical research study for eosinophilic gastritis with or without eosinophilic duodenitis

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): February 18, 2026
• Study Completion (Estimated): November 25, 2026

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD)
• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; Eosinophilic enteropathy; Immunologic Factors; Physiological Effects of Drugs; dupilumab
• Other Study ID Numbers: R668-EGE-2213; 2022-500795-62-00 (Registry Identifier: EUCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing 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

• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No