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Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: Report of the OPERA study

Gut Oct 10, 2017

Sandborn WJ, et al. - Researchers planned this phase II, randomised, double-blind, placebo-controlled clinical trial to determine the efficacy and safety of PF-00547659, a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule (MAdCAM) to selectively reduce lymphocyte homing to the intestinal tract, in patients with moderate-to-severe Crohn’s disease (CD). In these patients, clinical endpoint differences between PF-00547659 and placebo did not reach statistical significance. A sustained dose-related decrease in soluble MAdCAM and a dose-related increase in circulating β7+ central memory T cells suggested that PF-00547659 was pharmacologically active.
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