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NCT Number: NCT05831176

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stollery Children's Hospital - University of Alberta, Edmonton, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Treatment and study plan

Dupilumab

Drug

Administered as described in the protocol

Other names: DUPIXENT®, REGN668, SAR231893

Primary outcomes

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

    Time frame: Baseline up to 24 Weeks

Secondary outcomes

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

    Time frame: Baseline up to 52 Weeks

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

    Time frame: Up to 52 Weeks

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

    Time frame: 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

    Time frame: Up to 52 Weeks

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

    Time frame: Up to 52 Weeks

    Assessed for only those with duodenal involvement

  6. Absolute change in the EoG/EoD-SQ Total Symptom Score (TSS)

    Time frame: Baseline up to 52 Weeks

    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.

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

    Time frame: Baseline up to 52 Weeks

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

    Time frame: Baseline up to 52 Weeks

    Assessed for only those with duodenal involvement

  9. Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)

    Time frame: Baseline up to 52 Weeks

    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.

  10. Change in frequency of diarrhea episodes

    Time frame: Baseline up to 52 Weeks

    Assessed for only those with diarrhea at baseline

  11. Change in frequency of vomiting episodes

    Time frame: Baseline up to 52 Weeks

    Assessed for only those with vomiting at baseline

  12. Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature

    Time frame: Baseline up to 52 Weeks

    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.

  13. Change in the NES for the type 2 inflammation transcriptome signature

    Time frame: Baseline up to 52 Weeks

    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.

  14. Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature

    Time frame: Baseline up to 52 Weeks

    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.

  15. Proportion of participants who receive rescue medications or procedures

    Time frame: Up to 52 Weeks

  16. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 52 Weeks

    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.

  17. Incidence of treatment-emergent serious adverse events (SAEs)

    Time frame: Up to 52 Weeks

    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
  18. Incidence of treatment-emergent adverse events of special interest (AESIs)

    Time frame: Up to 52 Weeks

    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

  19. Incidence of TEAEs leading to permanent discontinuation of study treatment

    Time frame: Up to 52 Weeks

    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.

  20. Incidence of anti-drug antibody (ADA)

    Time frame: Up to 52 Weeks

    Immunogenicity will be characterized per drug molecule by ADA status

  21. Titer of ADA

    Time frame: Up to 52 Weeks

    Immunogenicity will be characterized per drug molecule by ADA status

  22. Incidence of neutralizing antibody (NAb) to dupilumab

    Time frame: Up to 52 Weeks

    Immunogenicity will be characterized per drug molecule by NAb status

  23. Concentrations of functional dupilumab in serum at each assessment time point

    Time frame: Baseline up to 64 Weeks

    The concentrations of functional dupilumab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Acronym: ENGAGE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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