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Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: A phase 2a, randomised, double-blind, placebo-controlled, parallel-group study

The Lancet: Gastroenterology & Hepatology Nov 15, 2019

Cellier C, Bouma G, van Gils T, et al. - In this phase 2a, randomised, double-blind, placebo-controlled, parallel-group study, researchers analyzed the impacts of AMG 714, an anti-IL-15 monoclonal antibody, on the activity and symptoms of refractory coeliac disease type 2. The sample consisted of adults with a confirmed diagnosis of refractory coeliac disease type 2. Participants in the study were randomly assigned at a 2:1 ratio to receive seven intravenous doses over 10 weeks of AMG 714 (8 mg/kg) or matching placebo. Twenty-eight patients were enrolled and randomly assigned to AMG 714 (n = 19) and placebo (n = 9) from April 13, 2016, to January 19, 2017. According to findings, no difference was found between the groups in terms of the primary endpoint of aberrant intraepithelial lymphocyte reduction from baseline in patients with refractory coeliac disease type 2 who were treated with AMG 714 or placebo for 10 weeks. In patients with refractory coeliac disease type 2, effects on symptoms and other endpoints suggest that further research of AMG 714 may be warranted. Nasopharyngitis was the most common adverse event in the AMG 714 group.
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