Depending on whether you are enrolled in Part A or Part B, your total participation in this study will last either 2 or 3 months. There will first be a screening visit to confirm your eligibility in the 28 days before you receive study drug or placebo. After screening, Part A lasts 22 days with [...]
There are no endoscopies in this study.
If you are assigned to Part A, you will be admitted to the study clinic for a 3-night stay, during which you will receive one dose of study medication or placebo and be observed and assessed by the study doctors. If you qualify through the online screening survey, a study team representative will discuss more [...]
In Part A, there is no gluten challenge. In Part B, there is one single-dose gluten challenge on one day. The gluten challenge in this study is used to measure how your body responds to a dose of gluten after receiving the study medication or placebo.
In Part A, 66% (2 of 3) participants will receive the study drug and 33% (1 of 3) of participants will receive the placebo. In Part B, 75% (3 of 4) of participants will receive the study drug and 25% (1 of 4) of participants will receive the placebo.
Yes. Your participation is completely voluntary. You can change your mind and withdraw from the study at any time.
If you pre-qualify through the online screening survey and live near a study site, you will be invited to schedule a phone call with a study representative to discuss your eligibility and potential participation. If you are interested, you will be contacted by the study site to schedule a screening visit. At this visit, you will [...]
This study has multiple locations across the US. For more information about the study site locations, please complete the screening survey to see if you may qualify. If you live near a study site, you will be invited to schedule a phone call with a study team representative to discuss your eligibility, potential participation, and [...]