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
NCT ID: NCT05831176
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
22 participants
INTERVENTIONAL
2023-05-03
2026-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dupilumab in Eosinophilic Gastritis
NCT03678545
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
NCT03633617
Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)
NCT02379052
A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
NCT06693531
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
NCT07112378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Part A is an open-label treatment period lasting up to 24 weeks (up to 6 months). "Open-label" means that you and the study doctors and the staff staff will know that you are taking the study drug
* Part C is an open-label extended treatment period lasting up to 28 weeks (about 7 months). "Extended Treatment Period" means that you will take the study drug for an additional 28 weeks after finishing Part A if you are eligible to take part in this part of the study
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dupilumab
Part A: Treatment Period Part C: Extended Treatment Period
Eligible participants from Part A will enter Part C
Dupilumab
Administered as described in the protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dupilumab
Administered as described in the protocol
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix Childrens Hospital
Phoenix, Arizona, United States
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
Duke University
Durham, North Carolina, United States
ESI Medical Research, PLLC
Kinston, North Carolina, United States
University of Cincinnati Medical Center-Children's Hospital Medical Center
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
The Oregon Clinic - Gastroenterology East
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
TDDC dba GI Alliance Research
Mansfield, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Home Health Company
Seattle, Washington, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Stollery Children's Hospital - University of Alberta
Edmonton, Alberta, Canada
Humanitas Research Hospital
Rozzano, Milan, Italy
AOOR Villa Sofia/Cervello
Palermo, Sicily, Italy
U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
Bari, , Italy
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma, , Italy
University of Rome - Pediatric Gastroenterology and Liver Unit
Rome, , Italy
Iizuka Hospital
Iizuka, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Kure Kyosai Hospital
Kure, Hiroshima, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo, Japan
Kobe University Graduate School of Medicine
Kobe, Hyōgo, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Yamagata University Hospital
Yamagata, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sia T, Bacchus L, Tanaka R, Khuda R, Mallik S, Leung J. Dupilumab Can Induce Remission of Eosinophilic Gastritis and Duodenitis: A Retrospective Case Series. Clin Transl Gastroenterol. 2024 Jan 1;15(1):e00646. doi: 10.14309/ctg.0000000000000646.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-500795-62-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R668-EGE-2213
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.