Takeda Pharmaceutical Company has reported positive top-line results from the VISIBLE 1 trial after meeting its primary endpoint.
VISIBLE 1 is a pivotal Phase lll, randomised, double-dummy, double-blind, placebo-controlled trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy for the treatment of moderately to severely active ulcerative colitis (UC).
The trial enrolled 384 patients who had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumour necrosis factor-alpha (TNFα)-antagonist therapy before being enrolled.
Patients who achieved clinical response at week six following two doses of open-label vedolizumab intravenous (IV) induction therapy were randomised into one of three treatment groups to receive vedolizumab SC at 108mg and placebo IV; vedolizumab IV at 300mg and placebo SC; or placebo SC and placebo IV.
They also received subcutaneous doses of the respective combinations every two weeks and intravenous doses every eight weeks.
The VISIBLE 1 trial met its primary endpoint after achieving clinical remission in a statistically significant proportion of patients receiving vedolizumab SC beginning at week six and every two weeks until week 52 compared to placebo.
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It has also reported consistent safety data with the known safety profile of vedolizumab. The trial did not report any new safety signals.
Takeda Pharmaceutical Company Gastroenterology Therapeutic Area Unit head Asit Parikh said: “These results are encouraging and build on vedolizumab’s robust clinical profile with more than 200,000 patient years of exposure.
“We plan to discuss these data with health authorities with the aim of bringing this innovative treatment option to patients.”
Takeda’s VISIBLE clinical trial programme includes three Phase lll studies that aim to evaluate the efficacy and safety of an investigational SC formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active UC and Crohn’s disease (CD).