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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 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

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.

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
668 Previous Clinical Trials
385,794 Total Patients Enrolled
1 Trials studying Eosinophilic Gastritis
41 Patients Enrolled for Eosinophilic Gastritis
SanofiIndustry Sponsor
2,204 Previous Clinical Trials
4,036,499 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
283 Previous Clinical Trials
254,803 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05831176 — Phase 2 & 3
Eosinophilic Gastritis Research Study Groups: Part B: Phase 3, Part C: Extended Active Treatment Period, Part A: Phase 2
Eosinophilic Gastritis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05831176 — Phase 2 & 3
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05831176 — Phase 2 & 3
~181 spots leftby Aug 2027