Coeliac disease refers to a condition where the immune system attacks the tissues of the body when a person eats gluten. This condition damages the small intestine and inhibits the absorption of nutrients. AMG 714 a monoclonal antibody for IL-15, a cytokine implicated in the pathophysiology of coeliac disease. This study aims to evaluate the safety and efficacy of AMG 714 in adults with coeliac disease.
In this randomized, parallel-group, placebo-controlled, double-blind, phase-2a trial, a total of 64 patients aged 18–80 years with a confirmed diagnosis of coeliac disease and adherence to a gluten-free diet for 12 months were enrolled. The patients were randomized in a 1:1:1 ration to 150 mg AMG 714, 300 mg AMG 714, or placebo. The primary outcome of the study was the change in the villous height-to-crypt depth (VHCD) ratio.
The findings suggested that AMG 714 did not prevent mucosal damage due to gluten challenge. The mean difference in the VCHD ratio was –2.49% between 150 mg AMG 714 and placebo, and +6.39% between 300 mg AMG 714 and placebo. However, further analysis suggested that neither of the comparisons was statistically significant.
Though 300 mg AMG 714 resulted in a greater positive change in the VCHD ratio, the final endpoint was not significantly different between 150 mg and 300 mg AMG 714 versus placebo.