The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to \<12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).
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.
Current or prior diagnosis of Crohn's disease or indeterminate colitis.
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.
Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).
Parallel
High dose budesonide rectal foam
DrugTwice a day for 2 weeks, then once a day for 4 weeks
Low dose budesonide rectal foam
DrugTwice a day for 2 weeks, then once a day for 4 weeks
Matching placebo rectal foam
DrugTwice a day for 2 weeks, then once a day for 4 weeks
Proportion of participants with clinical remission
Clinical remission based on the modified Mayo Clinic Score, defined as an endoscopy score ≤ 1 (excluding friability), a rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore ≤ 1. Each component is scored from 0 to 3, with total scores ranging from 0 to 9, with higher scores indicating more severe disease.
Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment
Scored from 0 to 3, with higher scores indicating more severe disease.
Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment.
Scored from 0 to 3, with higher scores indicating more severe disease.
Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment.
Scored from 0 to 3, with higher scores indicating more severe disease.
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