This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.
Clinical history
Characteristic endoscopic findings
Histopathology results from biopsies
Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.
Current or prior diagnosis of Crohn's disease or indeterminate colitis.
Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
Severe UC, defined as total Mayo score >10.
Not currently in an active phase or flare, defined as a total Mayo score <4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.