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 studies
- Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis
- Analyses of these data are ongoing to better understand the results
- Pivotal phase III study?of etrolizumab in Crohn?s disease?is?ongoing
- Roche is studying additional investigational medicines in inflammatory bowel diseases
- 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) agents8,9
- Phase 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 agents10
- Phase 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 agents11
- Phase 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 agents12
- COTTONWOOD study: An open-label extension and safety monitoring study of patients with moderately to severely ulcerative colitis previously enrolled in etrolizumab phase II/III studies13
- Phase 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 disease14
- JUNIPER 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
Dr. Nicolas Dunant Phone: +41 61 687 05 17 | Patrick Barth Phone: +41 61 688 44 86 |
Daniel Grotzky Phone: +41 61 688 31 10 | Karsten Kleine Phone: +41 61 682 28 31 |
Nina M?hlitz Phone: +41 79 327 54 74 | Nathalie Meetz Phone: +41 61 687 43 05 |
Barbara von Schnurbein Phone: +41 61 687 89 67 |
Roche Investor Relations | |
Dr. Karl Mahler Phone: +41 61 68-78503 e-mail:?karl.mahler@roche.com | Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail:?jon_kaspar.bayard@roche.com |
Dr. Sabine Borngr?ber Phone: +41 61 68-88027 e-mail:?sabine.borngraeber@roche.com | Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail:?bruno.eschli@roche.com |
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail:?birgit.masjost@roche.com | Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail:?gerard.tobin@roche.com |
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Investor Relations North America | |
Loren Kalm Phone: +1 650 225 3217 e-mail:?kalm.loren@gene.com | Dr. Lisa Tuomi Phone: +1 650 467 8737 e-mail:?tuomi.lisa@gene.com |