7810: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (ANTI-IL4RA) in Subjects with Eosinophilic Gastritis

For Diseases

• Eosinophilic Gastritis (EoG)

Background

This study is being conducted to determine the safety and effectiveness of a study drug called dupilumab in adolescents and adults with eosinophilic gastritis (EoG) with or without esophageal and/or duodenal eosinophilia. In this study, dupilumab is considered an experimental drug because it has not been approved by the US Food and Drug Administration (FDA) to treat EoG. Dupilumab is approved by the FDA for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis but not eosinophilic gastrointestinal diseases. We want to see how people with EoG feel while taking this drug and if dupilumab helps improve the inflammation in the stomach of people with EoG.

About this Study

This study has a double-blind and open label treatment period. “Double-blind” means that neither you nor the study doctor will know if you are receiving dupilumab or placebo. A placebo is an inactive substance, that looks like the medicine, but which contains no medicine. Once you complete the double-blind period, you may join the open-label portion of the study. During the open-label period you will receive dupilumab.

Your participation in this study may last up to 56 weeks including the screening period (up to 8 weeks), double-blind study treatment period (12 weeks), open label study treatment period (24 weeks), and a follow-up period (12 weeks). Visits are every 4 – 6 weeks with the exception of the first two visits which are every two weeks. Clinics visits will take 1 to 2 hours. Endoscopy visits will take up to 4 hours.

You may be asked to complete the following assessments and procedures that are specific to research:

• Questions about symptoms on an electronic diary
• Endoscopy with biopsies
• Subcutaneous (SC) injection (under the skin) of the study treatment
• Physical exam, vitals, height, and weight
• Blood and urine sample collections
• Medical history collections; and answer health-related questions
• Training on injection of study drug

Targeted Enrollment

To be eligible to participate, you must:

• Be male or female age 12-70
• Be diagnosed with: Eosinophilic Gastritis (EoG)
• Have symptoms of EoG

You are not eligible to participate if you have:

1. Systemic gastrointestinal disorders such as Crohn’s disease, inflammatory bowel disease, or Celiac disease.
2. Known or suspected active colitis
3. Hypereosinophilic syndrome
4. Ocular disorder
5. Initiation, discontinuation or change in the dosage regimen of the following medications within 8 weeks prior to the screening endoscopy:
   1. Proton pump inhibitors (PPIs)
   2. Leukotriene inhibitors Nasal and/or inhaled corticosteroids

How to Join

The sites listed on the right side of this page are participating in the study.