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
Running, not enrolling · Phase 2
Conditions studied: Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID), Eosinophilic Gastroenteritis
In brief
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 facts
- Study ID
- NCT05831176
- Run by
- Regeneron Pharmaceuticals
- People needed
- 22
- Starts
- 2023-05-03
- Expected to finish
- 2026-11-25
- Last updated by the study team
- 2026-07-01
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Om Research LLC — Apple Valley, California, United States
- Scripps Clinic — La Jolla, California, United States
- Om Research LLC — Lancaster, California, United States
- University of California - Los Angeles (UCLA) — Los Angeles, California, United States
- University of Southern California Keck School of Medicine — Los Angeles, California, United States
- GastroIntestinal BioSciences — Los Angeles, California, United States
- United Medical Doctors — Murrieta, California, United States
- Ucsf Medical Center (Benioff Childrens Hospital) — San Francisco, California, United States
- University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy — Aurora, Colorado, United States
- Connecticut Clinical Research Institute — Bristol, Connecticut, United States
- UConn Health — Farmington, Connecticut, United States
- Encore Borland-Groover Clinical Research — Jacksonville, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- University Of Kansas — Kansas City, Kansas, United States
- Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- MNGI Digestive Health P.A. — Plymouth, Minnesota, United States
- Mayo Clinic Hospital Rochester — Rochester, Minnesota, United States
- Advanced Research Institute — Reno, Nevada, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Northwell Health — Great Neck, New York, United States
- Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) — New York, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Charlotte Gastroenterology & Hepatology, PLLC — Charlotte, North Carolina, United States
- Phoenix Childrens Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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