BACKGROUND: Many @entity1 with active @entity30 do not adequately respond to therapies, highlighting the need for new treatments. AIMS: To conduct a randomised, double-blind, placebo-controlled phase 3 study to assess the efficacy and safety of vercirnon, an oral inhibitor of CC chemokine receptor-9, for the treatment of @entity1 with moderately-to-severely active @entity30 . METHODS: @entity1 with a @entity30 Activity Index (CDAI) of 220-450, plus evidence of @entity66 (endoscopically confirmed or elevation of both @entity1851 and faecal calprotectin), who had failed corticosteroid or immunosuppressant therapy were enrolled. @entity1 were equally randomised to receive placebo, vercirnon 500  mg once daily or vercirnon 500  mg twice daily. The primary endpoint was clinical response, defined as a 100-point decrease in CDAI from baseline to week 12. RESULTS: Six hundred and eight @entity1 were randomised. @entity1 characteristics and baseline demographics were similar among the groups. The proportions of @entity1 achieving a clinical response were 25.1%, 27.6% and 27.2% for placebo, once daily and twice daily respectively; treatment differences were not significant (2.5%; 95% confidence interval, CI -6.1% to 11.0%, P  =  0.546 for once daily vs. placebo, and 2.1%; 95% CI -6.5% to 10.7%, P  =  0.648 for twice daily vs. placebo). Adverse events were reported in 69.8%, 73.3% and 78.1% with serious adverse events in 8.9%, 5.9%, and 6.0% of @entity1 in the placebo, once-daily and twice-daily groups, respectively. CONCLUSIONS: We did not demonstrate efficacy of vercirnon as an induction therapy in @entity1 with moderately-to-severely active @entity30 ; its effect in maintenance therapy was not addressed.

Randomised clinical trial: vercirnon, an oral CCR9 antagonist, vs. placebo as induction therapy in active XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'Patient'] @entity30 :: ('MESH:D003424', 'Disease') :: ["Crohn's Disease", "Crohn's disease"] @entity66 :: ('MESH:D004194', 'Disease') :: ['active disease'] @entity1851 :: ('1401', 'Gene') :: ['C-reactive protein']
@entity30 :: (MESH:D003424,Disease) :: ['Crohn's disease']
