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Clinical Trials in the USA / NCT05831176
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 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2
Started
2023-05-03
Last updated
2026-07-01

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Dupilumab →

Dupilumab: Administered as described in the protocol

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)

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs) 2. Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening 3. Screening endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol 4. Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit 5. History (by participant report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening, as defined in the protocol 6. An average TSS of ≥ 20 calculated using data collected via the EoG/EoD-SQ eDiary per week for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scale of 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6 symptoms, as defined in the protocol. Key Exclusion Criteria: 1. Body weight less than 40 kg at screening 2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab 3. Helicobacter pylori infection 4. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening 5. History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery, as defined in the protocol 6. Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome 7. History of bleeding disorders, esophageal or gastric varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure 8. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 4 weeks prior to the screening visit. Participants on a food-elimination diet must remain on the same diet throughout the study 9. Planned or anticipated use of any prohibited medications and procedures during the study 10. Planned or anticipated major surgical procedure during the study 11. Receiving tube feeding or parenteral nutritional at screening NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
Phoenix Childrens Hospital Phoenix Arizona
Om Research LLC Apple Valley California
Scripps Clinic La Jolla California
Om Research LLC Lancaster California
University of California - Los Angeles (UCLA) Los Angeles California
University of Southern California Keck School of Medicine Los Angeles California
GastroIntestinal BioSciences Los Angeles California
United Medical Doctors Murrieta California
Ucsf Medical Center (Benioff Childrens Hospital) San Francisco California
University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy Aurora Colorado
Connecticut Clinical Research Institute Bristol Connecticut
UConn Health Farmington Connecticut
Encore Borland-Groover Clinical Research Jacksonville Florida
Northwestern University Chicago Illinois
University Of Kansas Kansas City Kansas
Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School Boston Massachusetts
University of Michigan Ann Arbor Michigan
MNGI Digestive Health P.A. Plymouth Minnesota
Mayo Clinic Hospital Rochester Rochester Minnesota
Advanced Research Institute Reno Nevada
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
Northwell Health Great Neck New York
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Charlotte Gastroenterology & Hepatology, PLLC Charlotte North Carolina
Duke University Durham North Carolina
ESI Medical Research, PLLC Kinston North Carolina
University of Cincinnati Medical Center-Children's Hospital Medical Center Cincinnati Ohio
Ohio State University Medical Center Columbus Ohio
Allergy, Asthma and Clinical Research Center Oklahoma City Oklahoma
The Oregon Clinic - Gastroenterology East Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
TDDC dba GI Alliance Research Mansfield Texas
University of Utah Salt Lake City Utah
Seattle Children's Home Health Company Seattle Washington
Froedtert Hospital Milwaukee Wisconsin
Stollery Children's Hospital - University of Alberta Edmonton Alberta
Humanitas Research Hospital Rozzano Milan
AOOR Villa Sofia/Cervello Palermo Sicily
U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale Bari Italy

+ 13 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05831176 on ClinicalTrials.gov ↗ ← All trials in the USA