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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
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).
Details
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 100 |
| Start date | 2027-06 |
| Completion | 2030-01 |
Conditions
- Ulcerative Colitis
Interventions
- High dose budesonide rectal foam
- Low dose budesonide rectal foam
- Matching placebo rectal foam
Primary outcomes
- Proportion of participants with clinical remission — Day 42
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.