Santarus initiates enrollment in UCERIS Phase IIIb study for ulcerative colitis

Feb 13 2012

Santarus, Inc. (NASDAQ: SNTS) today announced that it has begun patient enrollment in a multicenter, randomized, double-blind, placebo-controlled Phase IIIb clinical study with the investigational drug UCERIS™ (budesonide) tablets 9 mg to evaluate whether there is an incremental benefit when UCERIS 9 mg is added to current oral aminosalicylate (5-ASA) therapy for patients with mild or moderate active ulcerative colitis who are not adequately controlled on background 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. The primary endpoint of the study will be 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 expects to enroll approximately 500 patients, with 250 in each treatment arm, at approximately 120 clinical sites, with more than 50 percent 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 research and development at Santarus. "We expect to complete patient enrollment in the Phase IIIb study in the first half of 2013."

Source: Santarus, Inc.