Still Dealing With Celiac Symptoms, Even Though You're Gluten-Free?

What is this study about?

This study is looking at a new investigational medication for people who have been diagnosed with celiac disease, but who are still having symptoms and intestinal damage even though they've been following a gluten-free diet for a year or more.

This medication isn't meant to replace a gluten-free diet. Instead, it's designed to help block the body's immune reaction to gluten.

Here's a simple way to think about what's going on in the body: in people with celiac disease, the immune system mistakenly treats gluten as a threat. That overreaction is what ends up damaging the small intestine. The study medication is designed to target that immune response and help calm it down.

The medication is given as an injection under the skin.

As part of the study, participants will also take a small gluten capsule three times per week. Each capsule contains a very small amount of gluten, about what's in a small bite of white toast, similar to the kind of accidental gluten exposure that people with celiac disease sometimes run into in everyday life despite trying to avoid it. This helps the study team understand how well the medication protects the body from that kind of exposure.

Participants will also complete two endoscopy procedures during the study. These help the study team see what's going on in the small intestine at the start of the study, and then again later on to see whether things have improved.

Who Qualifies to Participate?

Because this study is for people with an ongoing, active case of celiac disease, we're looking for participants who fit a fairly specific profile.

In general, you'd be a good fit for this study if you:

Study participation

This study takes place over a total of about one year (around 54 weeks), broken down into a few different periods.

Here's the general flow:

In total, participation involves around 15 study visits spread out across that year, including the screening visit. Two of those visits involve an endoscopy procedure.

To help you picture how this plays out: during Period B, visits happen fairly often at first, roughly every 2 weeks for the first several visits, and then shift to about once a month for the remaining doses. After your last dose of study medication, you'll come back for a handful of follow-up visits spread out over the following several months.

Most regular visits last somewhere between 1 and 3 hours. The two endoscopy visits will take longer, since those involve a procedure.

In between visits, your "homework" is pretty simple: take the gluten capsules three times a week with your evening meal, and fill out a short daily symptom diary on your phone.

See if you qualify

Reach out to one of our friendly, knowledgeable recruiters. We’d love to hear from you.

Our phone number is 256-403-7711

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