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Dupilumab for Eosinophilic Gastritis
Phase 2
Waitlist Available
Led By Marc Rothenberg
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically active eosinophilic gastritis (EG) at time of screening, with a peak gastric count of ≥ 30 eos/hpf in at least 5 high power fields (hpfs) in the gastric antrum and/or body
History (by patient report) of moderate to severe EG symptoms
Must not have
Prior exposure to dupilumab
Current use of systemic steroids with daily dose > 10 mg for any reason or steroid burst for > 3 days within 1 month of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing whether dupilumab can treat eosinophilic gastritis by reducing the number of eosinophils in the stomach.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Dupilumab might cause allergic reactions, eye problems, inflammation of organs like the skin or lungs (eczema or asthma), injection site reactions, cold sores in your mouth or throat (oral herpes), joint pain (arthralgia), and headache.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active eosinophilic gastritis with high eosinophil counts in my stomach.
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I have experienced moderate to severe symptoms of esophageal disease.
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I am between 12 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with dupilumab.
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I am taking more than 10 mg of steroids daily or had a short course of high-dose steroids recently.
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I have a chronic digestive system condition like Crohn's, IBD, or Celiac.
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I am currently using, or have recently used, biological therapy.
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I have had cancer in the past.
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I have an eye condition.
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I have used steroids for asthma.
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I have not had sublingual immunotherapy in the last 6 months.
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I have a history of bleeding disorders or esophageal varices.
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I am expecting to undergo a major surgery during the study.
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I have an active parasitic infection.
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I am not willing to use effective birth control methods.
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I have been diagnosed with hypereosinophilic syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Relative change of peak eosinophil counts in the stomach
Secondary study objectives
Assessment of the value of baseline blood and esophageal biomarkers in predicting responsiveness to dupilumab.
Change in blood eosinophil counts
Change in histologic score of gastric mucosa
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: DupilumabActive Control2 Interventions
Group II: PlaceboPlacebo Group2 Interventions
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,562 Total Patients Enrolled
3 Trials studying Eosinophilic Gastritis
1,761 Patients Enrolled for Eosinophilic Gastritis
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,783 Total Patients Enrolled
1 Trials studying Eosinophilic Gastritis
279 Patients Enrolled for Eosinophilic Gastritis
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,192 Total Patients Enrolled
Marc RothenbergPrincipal InvestigatorCincinnati Children's Hospital Medical Center
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active eosinophilic gastritis with high eosinophil counts in my stomach.I have previously been treated with dupilumab.I am taking more than 10 mg of steroids daily or had a short course of high-dose steroids recently.I haven't changed my allergy shots in the last year.I have not had oral immunotherapy in the last 6 months.I have not taken antibiotics, antivirals, or antifungals in the last 2 weeks.I have recently started, stopped, or changed the dose of my acid reflux, asthma, or nasal allergy medication.I have a chronic digestive system condition like Crohn's, IBD, or Celiac.I am currently using, or have recently used, biological therapy.I have had cancer in the past.I have an eye condition.I have used steroids for asthma.I have not had sublingual immunotherapy in the last 6 months.I have experienced moderate to severe symptoms of esophageal disease.My esophageal condition is currently under control with medication.I have not received a live vaccine within the last 30 days and do not plan to while in the study.I have a history of bleeding disorders or esophageal varices.I am between 12 and 70 years old.I am expecting to undergo a major surgery during the study.I have an active parasitic infection.I am not willing to use effective birth control methods.I have been diagnosed with hypereosinophilic syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.