Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis

Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studiesEtrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitisAnalyses of these data are ongoing to better understand the resultsPivotal phase III study of etrolizumab in Crohn’s disease is ongoingRoche is studying additional investigational medicines in inflammatory bowel diseasesBasel, 10 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced topline results from its phase III study programme evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo.Phase III HIBISCUS I and II: Two identical, randomised, double-blind, double-dummy, placebo-controlled, multicentre studies evaluating the efficacy (induction of remission) and safety of etrolizumab versus adalimumab and placebo in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-tumour necrosis factor (anti-TNF) agents^8,9Phase III LAUREL: Randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy (maintenance of remission) and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents¹⁰Phase III GARDENIA: Randomised, multicentre double-blind, double-dummy study evaluating the efficacy (sustained remission) and safety of etrolizumab versus infliximab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents¹¹Phase III HICKORY: Double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of etrolizumab during induction and maintenance in patients with moderately to severely active ulcerative colitis who have been previously treated with anti-TNF agents¹²COTTONWOOD study: An open-label extension and safety monitoring study of patients with moderately to severely ulcerative colitis previously enrolled in etrolizumab phase II/III studies¹³Phase III BERGAMOT: A phase III, randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of etrolizumab as an induction and maintenance treatment in patients with moderately to severely active Crohn’s disease¹⁴JUNIPER study: An open-label extension and safety monitoring study of patients with moderately to severely active Crohn’s disease previously enrolled in the etrolizumab phase III BERGAMOT study¹⁵
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Attachment10082020_MR_etro top line results_EN