Phase 2 study relaunching in November

October 14, 2020

by Kate Avery, MPH, Director of Research & Patient Engagement

ImmunogenX put the Solutions for Celiac study (NCT04243551) on hold in March due to the COVID-19 pandemic. The study will relaunch in November at the original four sites: Columbia University (New York, NY); Mayo Clinic (Rochester, MN), and two private practice sites in Chesterfield, MI and Chattanooga, TN. 

The trial, funded by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), is testing ImmunogenX’s drug candidate latiglutenase (IMGX003), a drink-based medication consisting of two enzymes that degrade gluten in the stomach.

The study is monitoring how well latiglutenase relieves symptoms and improves quality of life in people with celiac disease in both real-world and known gluten exposure situations. Trial participants keep a daily symptom diary, the Celiac Disease Symptom Diary (CDSD©), while continuing normal daily routines and consuming either latiglutenase or placebo with each major meal. Once per week participants eat a small snack that sometimes contains gluten. 

Clinical trials across the US look a little different than they did before the pandemic, as trial sites navigate how to keep participants safe in this new environment. In this trial, all participants will be screened for potential COVID-19 symptoms and exposure before each study visit. Each trial site will also follow local public health precautions to protect participants.

Beyond Celiac is working with ImmunogenX to recruit for this clinical trial as part of our commitment to helping accelerate research. If you are interested in participating, you can learn more and see if you qualify at SolutionsforCeliac.com. You can also learn more about the study at ClinicalTrials.gov.

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