ACTIVE_NOT_RECRUITING

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

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Conditions

Eosinophilic Gastritis (EoG)Eosinophilic Duodenitis (EoD)Eosinophilic Gastrointestinal Disease (EGID)Eosinophilic GastroenteritisEosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Quick Facts

Study Start:2023-05-03
Study Completion:2026-11-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05831176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
  2. 2. Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening
  3. 3. Screening endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
  4. 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. 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. 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.
  1. 1. Body weight less than 40 kg at screening
  2. 2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
  3. 3. Helicobacter pylori infection
  4. 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. 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. 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. 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. 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. 9. Planned or anticipated use of any prohibited medications and procedures during the study
  10. 10. Planned or anticipated major surgical procedure during the study
  11. 11. Receiving tube feeding or parenteral nutritional at screening

Contacts and Locations

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
Om Research LLC
Apple Valley, California, 92307
United States
Scripps Clinic
La Jolla, California, 92037
United States
Om Research LLC
Lancaster, California, 93534
United States
University of California - Los Angeles (UCLA)
Los Angeles, California, 90024
United States
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
United States
GastroIntestinal BioSciences
Los Angeles, California, 90067
United States
United Medical Doctors
Murrieta, California, 92563
United States
Ucsf Medical Center (Benioff Childrens Hospital)
San Francisco, California, 94158
United States
University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy
Aurora, Colorado, 80045
United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010
United States
UConn Health
Farmington, Connecticut, 06030
United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
United States
Northwestern University
Chicago, Illinois, 60611
United States
University Of Kansas
Kansas City, Kansas, 66103
United States
Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
MNGI Digestive Health P.A.
Plymouth, Minnesota, 55446
United States
Mayo Clinic Hospital Rochester
Rochester, Minnesota, 55905
United States
Advanced Research Institute
Reno, Nevada, 89511
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Northwell Health
Great Neck, New York, 11021
United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, 10029
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207
United States
Duke University
Durham, North Carolina, 27710
United States
ESI Medical Research, PLLC
Kinston, North Carolina, 28513
United States
University of Cincinnati Medical Center-Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
United States
The Oregon Clinic - Gastroenterology East
Portland, Oregon, 97220
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
TDDC dba GI Alliance Research
Mansfield, Texas, 76063
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Seattle Children's Home Health Company
Seattle, Washington, 98105
United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-03
Study Completion Date2026-11-25

Study Record Updates

Study Start Date2023-05-03
Study Completion Date2026-11-25

Terms related to this study

Keywords Provided by Researchers

  • Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD)

Additional Relevant MeSH Terms

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