Roche has provided an update on its phase III study program comprising four Phase 3 trials evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis.  These trials are titled HIBISCUS I, HIBISCUS II, HICKORY, and LAUREL.

Roche has reported that in the HIBISCUS I induction study, etrolizumab met the primary endpoint (induction of remission with etrolizumab compared with placebo in week 10) in people without prior anti-tumour necrosis factor (anti-TNF) treatment. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, Roche reported that the trial did not meet its primary endpoint (induction of remission with etrolizumab compared with placebo in week 10). In the HICKORY study, Roche stated that etrolizumab met the primary endpoint at induction (remission at week 14) but not at maintenance (remission at week 66 among patients who showed clinical response at week 14) in people with prior anti-TNF treatment. Finally, Roche announced that etrolizumab failed to meet its primary endpoint (remission at week 62 among randomized patients with clinical response at week 10) in the LAUREL maintenance study in people without prior anti-TNF treatment. Roche also reported that the safety profile of etrolizumab was consistent with previous studies, and no major safety issues were identified in the four phase III clinical trials reported to date.

Roche reports that further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.

In addition to ulcerative colitis, etrolizumab is being studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease.