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ACTIVE NOT RECRUITING 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

NCT05831176 · View on ClinicalTrials.gov ↗

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)

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

FieldValue
Enrollment Target 22 participants
Start Date 2023-05-03
Est. Completion 2026-11-25
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05831176

The ClinicalTrials.gov registry entry for NCT05831176 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05831176 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Connecticut, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05831176?

The interventions under investigation include: Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05831176?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial