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

Status: RECRUITING

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.

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
The following sites are participating in the study:

Colorado

Children's Hospital Colorado
Contact: Rachel Andrews,Clinical Research Coordinator
720-777-7280
rachel.andrews@childrenscolorado.org

University of Colorado
Contact: Keanna Capener, Clinical Research Coordinator
303-724-8974
keanna.capener@cuanschutz.edu

Illinois

Northwestern University
Contact: Amanda Jarosik, Clinical Research Coordinator 
312-926-7618
amanda.jarosik@northwestern.edu

Indiana

Riley Children's Hospital
Contact: Gail Waltz, Clinical Research Nurse
317-944-9656
gwaltz@iu.edu

New York

Icahn School of Medicine at Mount Sinai
Contact: Emily Tamar Tatoian, Clinical Research Coordinator
650-815-8218
emily.tatoian@mssm.edu

North Carolina

University of North Carolina School of Medicine
Contact: Wyatt Moorer Clinical Research Coordinator
919-843-4480
wwmoorer@email.unc.edu

Ohio

Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati
Contact: Regina Yearout, Clinical Research Coordinator
513-517-2108
regina.yearout@cchmc.org

Pennsylvania

Children's Hospital of Philadelphia
Contact: Susan Lee, Clinical Research Coordinator
215-528-7314
Leess@chop.edu

University of Pennsylvania,Philadelphia
Contact: Christine Gepty, Clinical Research Nurse
215-349-8556
christine.gepty@pennmedicine.upenn.edu

Texas

Baylor College of Medicine / Texas Children's Hospital
Contact: Amanda Vega, Clinical Research Coordinator 
832-824-0939
amandav@bcm.edu

Utah

University of Utah
Contact: Brinnlie Harward, Clinical Research Coordinator
801-585-0894
Brinnlie.Harward@hsc.utah.edu



Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.