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news.GlaxoSmithKline (GSK) and ChemoCentryx have started treating first patient in a randomised, double-blind, placebo-controlled pivotal induction Phase III trial comparing Traficet-EN, now designated GSK1605786 ('786), to placebo investigating patients with crohn's disease.
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GSK and ChemoCentryx said that the study will assess the efficacy and safety of ‘786 for inducing a response and remission (reduction or disappearance of symptoms) and maintaining remission in over 2,500 patients with moderately-to-severely active crohn’s disease.
The primary and key secondary endpoints are the proportion of subjects achieving a treatment-induced clinical response based on the crohn’s Disease Activity Index (CDAI) and the proportion of subjects achieving clinical remission.