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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Administered as described in the protocol

Study Details

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)

Key Dates

Start date

May 3, 2023

Status verified

Oct 2025

Primary completion

Feb 18, 2026

Completion

Nov 25, 2026

Study Design

Enrollment

22 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Part A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C

Primary Outcome Measure

Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf) [ Time Frame: Baseline up to 24 Weeks ]

Locations (36)

Find similar trials in Phoenix, AZ

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