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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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. 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)

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

Conditions

• Eosinophilic Gastritis (EoG)
• Eosinophilic Duodenitis (EoD)
• Eosinophilic Gastrointestinal Disease (EGID)
• Eosinophilic Gastroenteritis

Interventions

Type	Name	Description
DRUG	Dupilumab	Administered as described in the protocol

Timeline

• Start date: 2023-05-03
• Primary completion: 2026-02-18
• Completion: 2026-11-25
• First posted: 2023-04-26
• Last updated: 2025-10-08

Locations

53 sites across 4 countries: United States, Canada, Italy, Japan

Regulatory

• FDA-regulated drug study