Dupilumab for Eosinophilic Gastritis

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byMarc Rothenberg

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marc Rothenberg

Principal Investigator

Cincinnati Children's Hospital Medical Center

Eligibility Criteria

This trial is for people aged 12-70 with Eosinophilic Gastritis, who can follow the study plan and have had stable symptoms and diet. They must not be on high-dose steroids, have certain infections or immune disorders, be pregnant/breastfeeding, or have a history of drug abuse or cancer.

Inclusion Criteria

I have active eosinophilic gastritis with high eosinophil counts in my stomach.

Willing and able to comply with study visits and activities

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

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Exclusion Criteria

I have previously been treated with dupilumab.

Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope

Inability or unwillingness of a participant to give written informed consent or comply with study protocol

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Treatment Details

Interventions

Dupilumab (Monoclonal Antibodies)
Placebo (Placebo)

Trial OverviewThe trial tests Dupilumab injections against a placebo in patients with Eosinophilic Gastritis. Participants receive shots every two weeks for 12 weeks. Those completing this may join a 24-week extension to get Dupilumab without being compared to a placebo.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: DupilumabActive Control2 Interventions

Group II: PlaceboPlacebo Group2 Interventions