Santarus announced results from its CORE I clinical study, one of two of the company’s pivotal Phase 3 clinical studies with Uceris (budesonide) in ulcerative colitis.
Uceris was evaluated for the treatment of active, mild to moderate ulcerative colitis in a multicenter, randomized, double-blind, double-dummy, placebo-controlled four-arm clinical study. CORE I compared Uceris 9mg or 6mg dosed once daily to placebo. The study included a reference arm utilizing a dose of two Asacol (mesalamine; Warner Chilcott) 400mg delayed-release tablets dosed three times a day resulting in a total of 2.4g daily. The trial enrolled a total of 509 patients.
The primary endpoint was the induction of combined clinical and endoscopic remission, defined as an overall UCDAI score ≤1 after 8 weeks of treatment with subscores of 0 for both rectal bleeding and stool frequency, a normal colonic mucosa without any sign of friability, and ≥1 point reduction from baseline in the endoscopic score.
The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at Week 8 in the Uceris 9mg group was significantly greater than that seen in the placebo group (17.9% vs. 7.4%, P=0.0143; odds ratio (OR): 2.71). The combined clinical and endoscopic remission rate for Uceris 6mg (13.2% vs. 7.4%, P=0.1393; OR: 1.9) and for the reference drug Asacol 2.4g (12.1% vs. 7.4%, P=0.22; OR: 1.71) were numerically greater than placebo, but the differences were not statistically significant.
Uceris is an investigational drug that contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon.
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