Santarus, a specialty pharmaceutical company, has begun patient enrollment in phase IIIb clinical study with the investigational drug Uceris (budesonide) tablets 9mg in combination with current oral aminosalicylate (5-ASA) therapy for patients with active ulcerative colitis.
Uceris is a locally acting (non-systemic) corticosteroid in an oral tablet formulation and is designed for controlled release and distribution of budesonide, which has a topical anti-inflammatory activity, throughout the length of the colon.
The multicenter, randomized, double-blind, placebo-controlled study will evaluate patients with mild or moderate active ulcerative colitis who continue using their current 5-ASA treatment regimen and for an eight-week period add either Uceris 9mg or placebo administered once daily. The primary endpoint of the study will be remission at week eight, defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score of less than or equal to one, with a zero score for rectal bleeding, stool frequency and mucosal appearance.
The company expects to enroll approximately 500 patients, with 250 in each treatment arm, at approximately 120 clinical sites, with more than 50% of the sites in the U.S. and the remainder in Canada and Europe.
“After consulting with key opinion leaders in gastroenterology, we concluded that as the treatment paradigm for ulcerative colitis continues to evolve evaluating Uceris as an add-on therapy is an important indication to explore,” said Wendell Wierenga, Ph.D., executive vice president of R&D at Santarus. “We expect to complete patient enrollment in the phase IIIb study in the first half of 2013.”
Santarus submitted a New Drug Application (NDA) to the FDA in December 2011.