On October 8th, 2026, argenx announced positive top-line results from the Phase 2 study of FB102, an investigational treatment for celiac disease. The findings suggest that FB102 may help protect the small intestine from damage caused by gluten exposure, offering encouraging progress toward new treatment options for people living with celiac disease.
For patients with celiac disease, eating gluten triggers an immune response that mistakenly attacks the lining of the small intestine. FB102 is designed to block CD122, a protein that helps immune cells receive signals telling them to become active and stay active. Think of CD122 as part of the immune system’s messaging system. By blocking these messages, FB102 aims to turn down the immune response that causes intestinal damage when someone with celiac disease is exposed to gluten.
The randomized, double-blind, placebo-controlled Phase 2 study enrolled 126 adults with celiac disease following a strict gluten-free diet without symptoms for the prior 12 months. During a controlled, eight-week gluten challenge, study participants received IV infusions of FB102 at one of two dose levels or received a placebo.
Study findings indicated:
- FB102 helped protect the small intestine from gluten-related damage: By day 78, researchers found a statistically significant difference in a measure of intestinal health between participants who received FB102 and those who received a placebo.
- Other measures, including immune cells in the lining of the small intestine and symptoms, also showed results consistent with less intestinal damage.
The Celiac Disease Foundation played an important role in helping recruit participants for this study, connecting people in the celiac disease community with an opportunity to contribute to research that could advance new treatment options.
These results are an encouraging step forward, but more research is needed to evaluate FB102’s safety and effectiveness as a celiac disease treatment. The Foundation will continue to follow developments in FB102 and other potential celiac disease treatments and share updates with the community as more data becomes available.