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Eosinophilic Gastritis (EoG)Phase 2ENGAGENCT05831176

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

A Phase 2 study testing Dupilumab in people with Eosinophilic Gastritis (EoG) and Eosinophilic Duodenitis (EoD), run by Regeneron Pharmaceuticals at 53 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Dupilumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
53 sitesin 4 countries
Study dates
3 May 2023to 25 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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
  • NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Trial locations and contacts

53 sites in 4 countries.

53 sites in 4 countries

United States36 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Om Research LLC

    Apple Valley, California, 92307

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

    Aurora, Colorado, 80045

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

    Boston, Massachusetts, 02215

  • Connecticut Clinical Research Institute

    Bristol, Connecticut, 06010

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • Northwestern University

    Chicago, Illinois, 60611

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

    Cincinnati, Ohio, 45229

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Duke University

    Durham, North Carolina, 27710

  • UConn Health

    Farmington, Connecticut, 06030

  • Northwell Health

    Great Neck, New York, 11021

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida, 32256

  • University Of Kansas

    Kansas City, Kansas, 66103

  • ESI Medical Research, PLLC

    Kinston, North Carolina, 28513

  • Scripps Clinic

    La Jolla, California, 92037

  • Om Research LLC

    Lancaster, California, 93534

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of California - Los Angeles (UCLA)

    Los Angeles, California, 90024

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90033

  • GastroIntestinal BioSciences

    Los Angeles, California, 90067

  • TDDC dba GI Alliance Research

    Mansfield, Texas, 76063

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • United Medical Doctors

    Murrieta, California, 92563

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

    New York, New York, 10029

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

  • MNGI Digestive Health P.A.

    Plymouth, Minnesota, 55446

  • The Oregon Clinic - Gastroenterology East

    Portland, Oregon, 97220

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Mayo Clinic Hospital Rochester

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84132

  • Ucsf Medical Center (Benioff Childrens Hospital)

    San Francisco, California, 94158

  • Seattle Children's Home Health Company

    Seattle, Washington, 98105

Other trials in United States

Japan9 sites

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo, 670-8560

  • Iizuka Hospital

    Iizuka, Fukuoka, 820-8505

  • Kobe University Graduate School of Medicine

    Kobe, Hyōgo, 650-0017

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken, 701-0192

  • Kure Kyosai Hospital

    Kure, Hiroshima, 737-8505

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Italy7 sites

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

    Bari, 70124

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

    Milan, 20162

  • AOOR Villa Sofia/Cervello

    Palermo, Sicily, 90146

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma, 00186

  • University of Rome - Pediatric Gastroenterology and Liver Unit

    Rome, 00161

  • Humanitas Research Hospital

    Rozzano, Milan, 20089

Other trials in Italy

Canada1 site

  • Stollery Children's Hospital - University of Alberta

    Edmonton, Alberta, T6G 1C9

Other trials in Canada

About this study

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

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.

Read more

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)
Read the 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
Being tested
Dupilumab
Keywords
Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD)
Medical subject headings
Eosinophilic enteropathy, Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called DUPIXENT®, REGN668, SAR231893

    Administered as described in the protocol

Study groups in NCT05831176
Study groupRoleWhat they receive
DupilumabExperimentalPart A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C
Receives: Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline up to 24 Weeks

Secondary outcomes (23)

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

    Measured: Baseline up to 52 Weeks

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

    Measured: Up to 52 Weeks

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

    Measured: Up to 52 Weeks

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

    Measured: Up to 52 Weeks

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

    Assessed for only those with duodenal involvement

    Measured: Up to 52 Weeks

  6. 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.

    Measured: Baseline up to 52 Weeks

  7. Percent change in the EoG/EoD-SQ TSS

    Measured: Baseline up to 52 Weeks

  8. Percent change in peak duodenal tissue eosinophil count (eos/hpf)

    Assessed for only those with duodenal involvement

    Measured: Baseline up to 52 Weeks

  9. 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.

    Measured: Baseline up to 52 Weeks

  10. Change in frequency of diarrhea episodes

    Assessed for only those with diarrhea at baseline

    Measured: Baseline up to 52 Weeks

  11. Change in frequency of vomiting episodes

    Assessed for only those with vomiting at baseline

    Measured: Baseline up to 52 Weeks

  12. 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.

    Measured: Baseline up to 52 Weeks

  13. 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.

    Measured: Baseline up to 52 Weeks

  14. 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.

    Measured: Baseline up to 52 Weeks

  15. Proportion of participants who receive rescue medications or procedures

    Measured: Up to 52 Weeks

  16. 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.

    Measured: Up to 52 Weeks

  17. 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

    Measured: Up to 52 Weeks

  18. 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

    Measured: Up to 52 Weeks

  19. 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.

    Measured: Up to 52 Weeks

  20. Incidence of anti-drug antibody (ADA)

    Immunogenicity will be characterized per drug molecule by ADA status

    Measured: Up to 52 Weeks

  21. Titer of ADA

    Immunogenicity will be characterized per drug molecule by ADA status

    Measured: Up to 52 Weeks

  22. Incidence of neutralizing antibody (NAb) to dupilumab

    Immunogenicity will be characterized per drug molecule by NAb status

    Measured: Up to 52 Weeks

  23. 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.

    Measured: Baseline up to 64 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start3 May 2023
  3. Primary completion23 Feb 2026
  4. Study completion25 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831176
Sponsor's protocol ID
R668-EGE-2213
Other IDs
2022-500795-62-00
Acronym
ENGAGE
Status last verified
Jun 2026
First submitted
14 Apr 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Publications

  • Shoda T, Taylor RJ, Sakai N, Rothenberg ME. Common and disparate clinical presentations and mechanisms in different eosinophilic gastrointestinal diseases. J Allergy Clin Immunol. 2024 Jun;153(6):1472-1484. doi: 10.1016/j.jaci.2024.03.013. Epub 2024 Mar 28.

    PubMed 38555071

  • 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.

    PubMed 37753954

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dupilumab in people with Eosinophilic Gastritis (EoG) and Eosinophilic Duodenitis (EoD), run by Regeneron Pharmaceuticals at 53 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Japan, Italy, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf) (time frame: Baseline up to 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831176, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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