Dupilumab in Eosinophilic Gastritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Eosinophilic Gastritis, Eosinophilic Gastroenteritis

In brief

40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.

Key facts

Study ID

NCT03678545

Run by

Children's Hospital Medical Center, Cincinnati

People needed

41

Starts

2021-05-15

Expected to finish

2024-11-13

Last updated by the study team

2025-11-04

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant and/or parent guardian must be able to understand and provide informed consent and/or assent.
• Willing and able to comply with study visits and activities
• Age ≥ 12 and < 71 years at study enrollment
• Histologically active EG at time of screening, with a peak gastric count of ≥ 30 eos/hpf in at least 5 hpfs in the gastric antrum and/or body.
• History (by patient report) of moderate to severe EG symptoms
• Stable medical management of EG.
• Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy.
• If have asthma and/or any other chronic allergic conditions they must be willing to maintain their pretrial medications until the end of study. Medication dose can be increased if there is a deterioration in the condition.
• Score on Asthma Control Test (ACTTM) ≥ 20

You may not qualify if…

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• Current active H. pylori infection.
• Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease.
• Known or suspected active colitis in the Principal Investigator's opinion or by biopsy.
• Hypereosinophilic syndrome.
• History of cancer
• Current or recent use of biological agents.
• Leukocyte count has not returned to the relevant lower limit of normal after discontinuing cell depleting biological agents.
• Current or recent use of any investigational drug.
• Current use of systemic steroids with daily dose > 10 mg for any reason or steroid burst for > 3 days within 1 month of screening.
• Prior exposure to dupilumab.
• History of anaphylaxis to any biologic therapy.
• Current pregnancy or breastfeeding.
• Ocular disorder.
• Individuals who have required use of a systemic corticosteroid for asthma.
• Received live vaccine 30 days prior to screening or planning on receiving a live vaccine during the time period that he/she is participating in the study.
• Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope.
• History of bleeding disorders or esophageal varices.
• Active parasitic infection.
• History of alcohol or drug abuse within 6 months prior to screening.
• Participant or his/her immediate family is a member of the investigational team.
• Planned or anticipated major surgical procedure during the study.
• Initiation, discontinuation or addition of allergens to subcutaneous immunotherapy (SCIT) within 12 months prior to screening.
• Treatment with sublingual immunotherapy (SLIT) within 6 months prior to screening.
• Treatment with oral immunotherapy (OIT) within 6 months prior to screening.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Colorado Denver and Hospital — Aurora, Colorado, United States
• Northwestern Medicine Digestive Health Center — Chicago, Illinois, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of North Carolina School of Medicine — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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