Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Korábbi kezelés

• Current or prior diagnosis of Crohn's disease or indeterminate colitis.
• 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.

Más betegség

• Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).
• Evidence or history of toxic megacolon or bowel resection.

Egyéb

• Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum;
• Severe UC, defined as an mMCS \> 8.
• Active proctologic pathology such as hemorrhoids, fistulas and fissures or other historical anatomic problems which would impair rectal administration (e.g., cloaca, imperforate anus history)

• Male and Female (non-pregnant and non-lactating) 5 to ≤17 years of age at Screening.
• Established diagnosis of UC, based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies.
• Disease limited to the distal colon and rectum, (disease involving only the first 15 centimeters or less proximal to the anal verge).
• Active, distal UC of mild or moderate severity, defined as a Modified Mayo Clinic Score (mMCS) between 4 and 8, inclusive, that includes an endoscopy subscore ≥ 2 and a rectal bleeding subscore ≥ 1.
• If on a background oral 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (Run-In) and the subject is willing to remain on the same dosage form and regimen for the duration of the study.