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A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure
Solutions for Celiac Study
| Sponsor: | Immunogenics, LLC |
| Enrolling: | Male and Female Patients |
| Study Length: | 26 Weeks |
| Clinic Visits: | 6 |
| IRB Number: | AAAR8816 |
| U.S. Govt. ID: | NCT03585478 |
| Contact: | Milka Monegro: 212-305-5422 / mjm2151@cumc.columbia.edu |
Additional Study Information:
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this study will assess the safety of the product.
This study is closed
Do You Qualify?
| Have you had a biopsy-confirmed diagnosis of celiac disease? | Yes | No |
| Have you been on a gluten-free diet for at least the past 12 months? | Yes | No |
| Do you still experience moderate to severe symptoms of abdominal pain and/or bloating despite your gluten-free diet? | Yes | No |
| Would you be willing to eat a small snack once per week for 17 weeks that may or may not contain small traces of gluten? | Yes | No |
| Will you be able to travel to the selected research site up to 6 times over the course of 6-7 months? | Yes | No |