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Crohn’s Disease Drug Fails Phase III Trial
Vercirnon does not improve clinical response compared with placebo (August 23)
The first of four phase III studies investigating vercirnon (GlaxoSmithKline), an investigational chemokine (C-C motif) receptor 9 (CCR9) antagonist, in adult patients with moderately to severely active Crohn’s disease did not achieve the primary endpoint of improvement in clinical response and the key secondary endpoint of clinical remission.
SHIELD-1 was a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of two dosages (500 mg once daily and 500 mg twice daily) of vercirnon compared with placebo over 12 weeks in 608 adult patients with moderately to severely active Crohn’s disease.
The study was conducted in patients whose disease was not adequately controlled with conventional therapy, and included patients who did not respond to tumor necrosis factor-alpha (TNF-alpha) antagonists.
The trial’s primary endpoint was the proportion of patients achieving a clinical response, defined as a decrease in the Crohn’s Disease Activity Index (CDAI) score of at least 100 points at 12 weeks. Clinical remission (CDAI score of less than 150 points) at 12 weeks was evaluated as a key secondary endpoint.
New recruitment and dosing in the ongoing clinical program for vercirnon have been suspended pending further review of the SHIELD-1 results.
Source: GlaxoSmithKline; August 23, 2013.