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Purpose

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

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dupilumab 		Part A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C
  • Drug: Dupilumab
    Administered as described in the protocol
    Other names:
    • DUPIXENT®
    • REGN668
    • SAR231893

Recruiting Locations

Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752 85016

Om Research LLC
Apple Valley 5324363, California 5332921 92307

Scripps Memorial Hospital La Jolla
La Jolla 5363943, California 5332921 92037

Om Research LLC
Lancaster 5364940, California 5332921 93534

United Gastroenterologists
Los Alamitos 5368304, California 5332921 90720

University of Southern California Keck School of Medicine
Los Angeles 5368361, California 5332921 90033

GastroIntestinal BioSciences
Los Angeles 5368361, California 5332921 90067

University of California - Los Angeles (UCLA)
Los Angeles 5368361, California 5332921 90095

United Medical Doctors
Murrieta 5375911, California 5332921 92563

Ucsf Medical Center (Benioff Childrens Hospital)
San Francisco 5391959, California 5332921 94158

Connecticut Clinical Research Institute
Bristol 5282835, Connecticut 4831725 06010

Uconn Health
Farmington 4834272, Connecticut 4831725 06030

Encore Borland-Groover Clinical Research
Jacksonville 4160021, Florida 4155751 32256

Northwestern University
Chicago 4887398, Illinois 4896861 60611

Gi Alliance
Gurnee 4894861, Illinois 4896861 60031

The University of Iowa Hospitals & Clinics
Iowa City 4862034, Iowa 4862182 52242

University Of Kansas
Kansas City 4273837, Kansas 4273857 66103

Boston Specialists
Boston 4930956, Massachusetts 6254926 02111

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
Boston 4930956, Massachusetts 6254926 02215

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109

Minnesota Gastroenterology, P.A.
Plymouth 5041926, Minnesota 5037779 55446

Mayo Clinic Hospital Rochester
Rochester 5043473, Minnesota 5037779 55905

Advanced Research Institute
Reno 5511077, Nevada 5509151 89511

Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756

Northwell Health
Great Neck 5119218, New York 5128638 11021

Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York 5128581, New York 5128638 10029

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 275997080

Charlotte Gastroenterology & Hepatology, PLLC
Charlotte 4460243, North Carolina 4482348 28207

Duke University
Durham 4464368, North Carolina 4482348 27710

ESI Medical Research, PLLC
Kinston 4474436, North Carolina 4482348 28513

University of Cincinnati Medical Center-Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229

Ohio State University Medical Center
Columbus 4509177, Ohio 5165418 43210

Allergy, Asthma and Clinical Research Center
Oklahoma City 4544349, Oklahoma 4544379 73120

The Oregon Clinic - Gastroenterology East
Portland 5746545, Oregon 5744337 97220

Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Vanderbilt University Medical Center-Digestive Disease Center
Nashville 4644585, Tennessee 4662168 37232

Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 76104

TDDC dba GI Alliance Research
Mansfield 4709013, Texas 4736286 76063

University of Utah
Salt Lake City 5780993, Utah 5549030 84132

Seattle Children's Home Health Company
Seattle 5809844, Washington 5815135 98105

Froedtert Hospital
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID
NCT05831176
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Detailed Description

This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants - 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center