Uceris is a locally acting corticosteroid that utilizes proprietary MMX multi-matrix system technology to enable controlled release and distribution of budesonide throughout the length of the colon.
The multicenter randomized double-blind placebo-controlled Phase IIIb clinical study will investigate if there is an incremental benefit when Uceris 9 mg is added to current oral aminosalicylate (5-ASA) therapy.
The Phase IIIb study will evaluate patients with mild or moderate active ulcerative colitis who continue using their current 5-ASA treatment regimen and for an 8 week period add either Uceris 9 mg or placebo administered once daily.
In the study, the primary endpoint includes remission at week 8, defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score of less than or equal to 1, with a zero score for rectal bleeding, stool frequency and mucosal appearance.
The company plans to enroll around 500 patients at approximately 120 clinical sites.
Santarus Research and Development executive vice president Wendell Wierenga said they anticipate completing patient enrollment in the Phase IIIb study in the first half of 2013.