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NCT05831176 · ClinicalTrials.gov registry record · Phase 2
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 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis (EoG), sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 20
- Study locations
NCT05831176: Active Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis (EoG), sponsored by Regeneron Pharmaceuticals.
NCT05831176 is a Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis (EoG) that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 22 participants, below the 409-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05831176, a Phase 2 study of Eosinophilic Gastroenteritis and Eosinophilic Gastritis (EoG), is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 20
- Study locations
Study 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)
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (20)
California
- Om Research LLC - Apple Valley
- Scripps Clinic - La Jolla
- Om Research LLC - Lancaster
- University of California - Los Angeles (UCLA) - Los Angeles
- University of Southern California Keck School of Medicine - Los Angeles
- GastroIntestinal BioSciences - Los Angeles
- United Medical Doctors - Murrieta
- Ucsf Medical Center (Benioff Childrens Hospital) - San Francisco
Connecticut
- Connecticut Clinical Research Institute - Bristol
- UConn Health - Farmington
Minnesota
- MNGI Digestive Health P.A. - Plymouth
- Mayo Clinic Hospital Rochester - Rochester
Arizona
- Phoenix Childrens Hospital - Phoenix
Colorado
- University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy - Aurora
Florida
- Encore Borland-Groover Clinical Research - Jacksonville
Illinois
- Northwestern University - Chicago
Kansas
- University Of Kansas - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-05-03 |
| Est. Completion | 2026-11-25 |
| Phase | Phase 2 |
What the registry record for NCT05831176 still lists
NCT05831176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 409-participant average among 5 other Eosinophilic Gastroenteritis trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Eosinophilic Gastroenteritis appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT05831176 names 20 study sites across 11 states, led by California, Connecticut, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05831176 about?
NCT05831176 is a clinical study titled "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". 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/imm...
What is the current status of trial NCT05831176?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2023-05-03. Estimated completion is 2026-11-25.
What conditions does trial NCT05831176 study?
This clinical trial studies the following conditions: Eosinophilic Gastroenteritis, Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID).
What interventions are being tested in trial NCT05831176?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05831176?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05831176 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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