Genentech Reports Mixed Results from Phase 3 Program of Etrolizumab for Moderate to Severe Active Ulcerative Colitis

Genentech Reports Mixed Results from Phase 3 Program of Etrolizumab for Moderate to Severe Active Ulcerative Colitis

Genentech announced topline results from its Phase III study program evaluating the etrolizumab in patients with moderate 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. 

The studies reported include HIBISCUS I and II: Two identical, randomized, double-blind, double-dummy, placebo-controlled, multicenter studies evaluating the efficacy (induction of remission) and safety of etrolizumab versus adalimumab and placebo in patients with moderate to severely active ulcerative colitis who have not been previously treated with anti-tumor necrosis factor (anti-TNF) agents. HICKORY: Double-blind, placebo-controlled, multicenter 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 agents. LAUREL: Randomized, double-blind, placebo-controlled,...

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