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Santarus Inc launches Phase IIIb trial of UCERIS as an add-on therapy in patients with mild or moderate active ulcerative colitis.

M2 EQUITYBITES-February 15, 2012-Santarus Inc launches Phase IIIb trial of UCERIS as an add-on therapy in patients with mild or moderate active ulcerative colitis(C)2012 M2 COMMUNICATIONS http://www.m2.com

Biopharmaceutical company Santarus Inc (NASDAQ:SNTS) reported on Monday the initiation of patient enrollment in a Phase IIIb clinical study of its investigational drug UCERIS tablets 9 mg as add-on therapy for patients with mild or moderate active ulcerative colitis, a form of inflammatory bowel disease (IBD).

This randomised, double-blind, placebo-controlled Phase IIIb clinical study will 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 company said that 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.

According to the company, it expects to enroll about 500 patients, with 250 in each treatment arm, at approximately 120 clinical sites, with more than 50% of the sites in the US and the remainder in Canada and Europe.

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Publication:M2 EquityBites (EQB)
Article Type:Clinical report
Date:Feb 15, 2012
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