What side effects are associated with this type of intervention?

Dupilumab, an IL-4 and IL-13 inhibitor, is being studied for its effects on Eosinophilic Gastritis. Known side effects of Dupilumab include injection site reactions, conjunctivitis, blepharitis, oral herpes, and other herpes simplex virus infections. Additionally, some patients may experience eosinophilia, which is an elevated level of eosinophils in the blood. These side effects are generally consistent with those observed in treatments targeting similar pathways for other conditions.

What prior FDA approvals exist?

There are no specific mentions of prior FDA approvals for the treatment of Eosinophilic Gastritis (EoG) in the provided context. Dupilumab, which is being studied for EoG, works by inhibiting IL-4 and IL-13 signaling pathways to reduce inflammation. This mechanism is similar to its use in other conditions like atopic dermatitis, where it has shown efficacy. However, for EoG specifically, the context does not provide information on previously approved treatments.

What other types of research exist?

Promising novel alternatives to Dupilumab for Eosinophilic Gastritis patients include Lebrikizumab, an IL-13 inhibitor, and Fezakinumab, an IL-22 antagonist. Both have shown efficacy in reducing inflammation in related conditions such as atopic dermatitis. Further clinical trials are needed to confirm their effectiveness specifically for EoG.

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Monoclonal Antibodies

Dupilumab for Eosinophilic Gastrointestinal Diseases (ENGAGE Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24 and at week 52

Summary

This trial is testing a new drug called dupilumab to see if it can help people aged 12 and older who have a condition that causes too many white blood cells to gather in their stomach and small intestine, leading to inflammation and damage. The study will compare the effects of dupilumab to another treatment and will also look at side effects and how the body reacts to the drug.

Who is the study for?

Adults and adolescents aged 12+ with active eosinophilic gastritis (EoG), not just duodenitis, can join this trial. They must have a history of EoG symptoms, documented diagnosis, and meet specific symptom severity scores. Exclusions include Helicobacter pylori infection, certain dietary changes before screening, major upcoming surgery, other gastric conditions like Crohn's disease or past dupilumab use.

What is being tested?

The study tests the safety and effectiveness of an experimental drug called dupilumab in two different doses compared to a placebo for treating EoG with or without EoD. It will also examine how much drug is in the blood over time and if the body creates antibodies against it.

What are the potential side effects?

Potential side effects from taking dupilumab may include allergic reactions, possible development of antibodies that could reduce drug effectiveness or cause additional side effects; detailed side effect profiles will be studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24 and at week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24 and at week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 and at week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute change in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS)

Proportion of participants achieving a peak gastric eosinophil count of ≤6 eosinophils/high power field (eos/hpf)

Secondary study objectives

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

Absolute change in the EoG/EoD-SQ TSS

Change in frequency of diarrhea epispodes

+21 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C: Extended Active Treatment PeriodExperimental Treatment3 Interventions

Eligible participants from Part A and Part B will enter Part C. Part A participants will get Dose 1. Part B participants who received Dose 1 or Dose 2 will remain on Dose 1 or Dose 2. Part B placebo participants will be randomized 1:1 to receive Dose 1 or Dose 2.

Group II: Part B: Phase 3Experimental Treatment3 Interventions

Randomized 1:1:1

Group III: Part A: Phase 2Experimental Treatment2 Interventions

Randomized 1:1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matching Placebo

2012

Completed Phase 4

~10710

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Eosinophilic Gastritis (EoG) treatments often focus on reducing inflammation and modulating the immune response. Dupilumab, for example, inhibits IL-4 and IL-13 signaling pathways, which are key in the inflammatory process. This is important for EoG patients because the disease involves the accumulation of eosinophils in the stomach lining, causing inflammation and damage. By targeting these specific cytokines, Dupilumab can help reduce eosinophil levels and alleviate symptoms. Other common treatments include corticosteroids, which broadly suppress the immune system, and dietary management to avoid allergens that trigger eosinophil accumulation.