Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Prior treatment

• Current or prior diagnosis of Crohn's disease or indeterminate colitis.
• Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).
• Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).
  • NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.

Other illness

• Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
• 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.
• Evidence or history of toxic megacolon or bowel resection.

Other

• Severe UC, defined as total Mayo score \>10.

• Established diagnosis of UC is based on:
  • 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.
• Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.
• If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.