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Dupilumab for Eosinophilic Gastritis
Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I have experienced moderate to severe symptoms of esophageal disease.
Select...
I am between 12 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative change of peak eosinophil counts in the stomach
Secondary outcome measures
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
815 Previous Clinical Trials
6,531,555 Total Patients Enrolled
3 Trials studying Eosinophilic Gastritis
1,761 Patients Enrolled for Eosinophilic Gastritis
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,806 Total Patients Enrolled
1 Trials studying Eosinophilic Gastritis
279 Patients Enrolled for Eosinophilic Gastritis
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,538 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some other examples of trials that have been run using Dupilumab?
"Dupilumab was first studied in 2015 at the Regeneron Investigational Site. To date, 54 clinical trials have been completed, with 53 trials currently recruiting patients. A large number of these studies are being conducted in Indianapolis, Indiana."
Answered by AI
Are people below the age of 50 allowed to participate in this research?
"According to the eligibility requirements, potential participants must be between 12 and 70 years old."
Answered by AI
What are the common maladies that Dupilumab is indicated for?
"Dupilumab can be used as treatment for patients with atopic dermatitis who have failed corticosteroid therapy and have eosinophil levels."
Answered by AI
Is there still room for more volunteers in this experiment?
"The trial, which was initially posted on May 15th, 2021, is still recruiting patients, as per the information available on clinicaltrials.gov. The listing was last edited on June 16th, 2022."
Answered by AI
Are there any documented dangers in using Dupilumab?
"Given that this is a Phase 2 trial, and thus only preliminary data supports Dupilumab's safety, it received a score of 2."
Answered by AI
Is this research project something new?
"As of right now, 53 different Dupilumab studies are ongoing in 455 cities and 43 countries. The first Dupilumab study began in 2015. That initial trial, which was sponsored by Sanofi and had 880 patients, completed its Phase 3 drug approval stage in 2015. In the years since then, 54 more trials have been completed."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Texas Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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