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Back to all Current clinical trials
ENGAGE
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EGE) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EGE 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 EGE (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, compared to placebo.
- Category
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Trial status
Recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
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ERM Project ID
101343
Trial contact details
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Contact person
IBD Clinical Trials
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Phone
0400 757 347
What you need to know
Who can take part?
- Aged 14 or older
- Biopsy confirmed diagnosis of Eosinophilic gastritis (EGE) at least 3 months prior to screening
- Study endoscopic biopsies with evidence of eosinophilic infiltration for a diagnosis of EGE
- Recorded symptoms matching study requirements during the screening period with history of same in the 2 weeks prior
Exclusions:
- Body weight less than 40 kg
- 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
- Other causes of gastric and, if applicable, duodenal eosinophilia or other medical conditions likely to impact participation
- History of bleeding disorders, that would place the participant at undue risk for significant complications from an endoscopy procedure
- Change to diet in the 4 weeks prior to enrolment or over the course of the study
- Planned or anticipated surgery
Trial dates
June 2024 - December 2025
