Phase 2 study of FB102 follows from positive Phase 1 results
Kate Avery, Senior Director of Science
Forte Biosciences is launching their new Phase 2 clinical trial in the United States. FB102-301 is a clinical trial assessing FB102, a new potential celiac disease treatment. The trial is enrolling approximately 100 participants and will have up to 30 sites across the United States.
When someone with celiac disease ingests gluten, the immune system releases cytokines, which create inflammation and damage in the small intestine. Disrupting the immune reaction to gluten is one of the approaches to treatment in the drug development pipeline. FB102 is designed to target two of these cytokines, interleukin-2 (IL-2) and interleukin-15 (IL-15). IL-2 and IL-15 are key cytokines in the immune system’s response to gluten in people with celiac disease.
A previous Phase 1 trial of FB102 with 32 participants looked at intestinal damage and symptoms over the study period, which included a 16-day gluten exposure. Participants who received the study drug had less damage to their small intestine and fewer markers of inflammation at the end of the study. They also had fewer symptoms during the gluten exposure. FB102 was well tolerated, meaning study participants did not experience severe side effects.
The current phase 2 trial will test two different FB102 doses during the study. Approximately 100 participants will be enrolled, and 80% of participants will receive the study drug. To qualify, participants must be 18 to 70 years of age, have been diagnosed with celiac disease by biopsy and a positive blood test at least 12 months ago, and be currently following a gluten-free diet. Additional criteria will also apply.
The primary goal of the FB102-301 study is to see how well the study drug protects the small intestine from damage when exposed to gluten. Participants will receive eight total FB102 infusions: five weekly and three biweekly thereafter. To understand how well the small intestine is being protected from damage, trial participants will have two endoscopies with biopsies, one at the beginning of the study and another about three months later, at the end of the 54-day gluten exposure period. Over the 26-week study, participants will have up to 16 clinic visits and be asked to complete a brief daily symptom diary.
If you are interested in learning more about the study and to see if you may qualify, visit the study website. [Recruitment has closed for this phase]
Beyond Celiac is helping to recruit for this study as part of our mission to accelerate research.