Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-releas
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continu
| Condition(s) | Ulcerative Colitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products. |
| Who can participate | Inclusion Criteria: * Established diagnosis of UC is based on: * Clinical history * Characteristic endoscopic findings * Histopathology results from biopsies * Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline. * Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1. * If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study. Exclusion Criteria: 1. Current or prior diagnosis of Crohn's disease or indeter |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Lead sponsor | Bausch Health Americas, Inc. |
| Locations | Garden Grove, California, United States; Indianapolis, Indiana, United States; The Bronx, New York, United States; Greenville, North Carolina, United States |
| Start date | 2023-09-29 |
| NCT ID | NCT04314375 |
| Official listing | https://clinicaltrials.gov/study/NCT04314375 |