Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: A phase 2a, randomised, double-blind, placebo-controlled study
The Lancet: Gastroenterology & Hepatology Nov 15, 2019
Lähdeaho ML, Scheinin M, Vuotikka P, et al. - In this randomised, double-blind, placebo-controlled, parallel-group, phase 2a trial, researchers analyzed the impacts of AMG 714 in coeliac disease patients who had gluten challenge. This trial was carried out at three clinical sites in Finland. Participants in the study were randomly assigned (1:1:1) to 150 mg AMG 714, 300 mg AMG 714, or placebo using permuted blocks and stratified by study site and gender. Sixty-four individuals were enlisted and randomly assigned to either the 150 mg AMG 714 group (n = 22), the 300 mg AMG 714 group (n = 22), or the placebo group (n = 20) between April 13, 2016, and November 22, 2016. According to findings, the primary endpoint, change in villous height-to-crypt depth ratio from baseline following 12 weeks of treatment in coeliac disease patients facing gluten challenge, was not significantly different at either 150 mg or 300 mg between placebo and AMG 714. In patients with non-responsive coeliac disease, effects on intraepithelial lymphocyte density and symptoms indicate that further research of AMG 714 may be warranted. Gastrointestinal disorders and injection site reactions were the most common adverse events. There have been no serious adverse events.
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