A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease
(AGY-010 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing AGY, a treatment that neutralizes a harmful protein in gluten, in people with celiac disease who still have symptoms despite a gluten-free diet. The study aims to see if AGY can reduce symptoms and improve quality of life. Participants will be of various ages and have confirmed celiac disease. AGY is a novel egg yolk-derived antibody designed to neutralize gluten and improve the efficacy of a gluten-free diet in celiac disease patients.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use ASA (aspirin) or NSAIDs (non-steroidal anti-inflammatory drugs) daily.
What safety data exists for placebo treatments in clinical trials?
How does the treatment AGY differ from other treatments for this condition?
Who Is on the Research Team?
Justine Turner, MD, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AGY or placebo in a double-blind, crossover design to evaluate efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGY
- placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Igy Inc.
Lead Sponsor
Vetanda Group Ltd
Collaborator
Vetanda
Collaborator