Takeda Pharmaceutical has reported that the VISIBLE 2 clinical trial of a subcutaneous (SC) formulation of vedolizumab met its primary endpoint in adults with moderately to severely active Crohn’s disease (CD).
The Phase III trial was intended to assess the safety and efficacy of a 108mg dose of the SC formulation as maintenance therapy in patients who had a clinical response at week six following treatment with two doses of open-label, 300mg intravenous (IV) vedolizumab at weeks zero and two.
From week six, participants were given vedolizumab SC every two weeks up to week 50.
According to the top-line results, the SC formulation led to clinical remission at week 52 in a statistically significant proportion of subjects, compared to placebo.
Safety analysis showed that adverse events reported during the trial were consistent with the known profile of the IV formulation, without any new signals.
Takeda Gastroenterology therapeutic area unit head Asit Parikh said: “Meeting the primary endpoint of the VISIBLE 2 study marks a crucial step in our efforts to help patients with Crohn’s disease as to how they may receive treatment with vedolizumab, whether that is intravenously or subcutaneously.
“These data, alongside the pivotal VISIBLE 1 results in ulcerative colitis, provide a more comprehensive picture of the new investigational subcutaneous formulation of vedolizumab as maintenance therapy for both ulcerative colitis (UC) and Crohn’s disease.”
Vedolizumab is a gut-selective biologic developed as a humanised monoclonal antibody. The IV formulation of the drug has approvals in more than 60 countries to treat moderately to severely active UC and CD in certain patients.
The randomised, double-blind, placebo-controlled VISIBLE 2 trial assessed the SC formulation in a total of 644 patients.
VISIBLE 2 forms part of Takeda’s clinical trial programme to assess vedolizumab SC as maintenance therapy in adults with moderately to severely active UC or CD.