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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Twice a day for 2 weeks, then once a day for 4 weeks
Twice a day for 2 weeks, then once a day for 4 weeks
Twice 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.
Time frame: Day 42
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.
Time frame: Day 42
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.
Time frame: Day 42
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.
Time frame: Day 42
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.