Date: 2013-08-23
Type of information:
phase: 3
Announcement: results
Company: GSK (UK) ChemoCentryx (USA)
Product: vercirnon (Traficet-EN, now designated GSK1605786 (‘786)
Action mechanism: Vercirnon is an orally bioavailable CCR9 antagonist which GSK licensed from ChemoCentryx in January 2010.
Disease: Crohn's disease
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country:
Trial
details: The Phase III clinical development programme, that is anticipated to include another pivotal induction study and a pivotal maintenance study, in addition to other studies, will evaluate 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. This randomised, double-blind, placebo-controlled study will involve approximately 600 patients to evaluate 500mg of ‘786 once daily or twice daily compared to placebo in 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.GSK has initiated four pivotal Phase III clinical trials intended to obtain the clinical results necessary to apply for marketing approval for vercirnon in Crohn's disease. In general, the development approach of the Phase III program is modeled after the design of our PROTECT-1 clinical trial. The following pivotal Phase III clinical trials are currently ongoing:SHIELD-1 is a multi-national, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of two doses, 500mg once-daily and 500mg twice-daily, of vercirnon over 12 weeks of treatment in approximately 600 adult patients with moderate-to-severe Crohn's disease. Patient recruitment was initiated in December 2010. Data from the induction phase of the SHIELD-1 trial are expected in the second half of 2013.SHIELD-2 is a multi-national, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of two doses, 500mg once-daily and 500mg twice-daily, of vercirnon in maintaining disease remission over 52 weeks in approximately 750 adult patients with Crohn's disease. Eligible patients will have achieved disease improvement and/or remission in SHIELD-1 or will be fed from SHILED-4 as noted below. Patient recruitment was initiated in April 2011.SHIELD-3 is a multi-national, open-label clinical trial to evaluate the safety and effectiveness of 500mg twice-daily of vercirnon over 108 weeks in approximately 800 adult patients with Crohn's disease. Patients completing previous clinical trials with the drug or patients who withdraw early from the SHIELD-2 maintenance clinical trial may be eligible to participate. Patient recruitment was initiated in April 2011.SHIELD-4 is a multi-national, randomized, double-blind clinical trial with the primary objective to induce clinical response and/or remission with vercirnon in subjects with active Crohn's disease to qualify subjects for enrollment into SHIELD-2, the 52-week maintenance clinical trial. Patients receive either 500mg once-daily or 500mg twice-daily for 12 weeks in this clinical trial. Patient recruitment was initiated in November 2011.
Latest
news: * On August 23, 2013, GSK has announced that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon - an investigational 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.The rates of serious adverse events and withdrawals due to adverse events were similar among the treatment groups, but there was a trend for dose-dependent increases in overall adverse event rates. GSK will continue to explore the safety and efficacy results to inform decisions about the clinical development programme for vercirnon. New recruitment and dosing in the ongoing clinical programme has been suspended pending further review of the SHIELD-1 results.
The full results from the SHIELD-1 study will be submitted to a forthcoming scientific congress and peer-reviewed scientific journal.
