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

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).

NCT Number	NCT05976802
Lead Sponsor	Bausch Health Americas, Inc.
Conditions	Ulcerative Colitis
Enrollment	100 participants
Start Date	2027-06
Primary Completion	2029-06 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-18