clinical trial · NCT05976802
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
Bausch Health Americas, Inc.·phase4·not yet recruiting·n = 100
Ulcerative ColitisHigh dose budesonide rectal foamLow dose budesonide rectal foamMatching placebo rectal foam
brief summary
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).
started
Jun 1, 2027
primary completion
Jun 1, 2029
completion
Jan 1, 2030
last updated
Sep 18, 2025
official title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol