NCT04314375
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
Recruiting · Phase 4 · Bausch Health Americas, Inc. · registry updated 2025-09-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- Current or prior diagnosis of Crohn's disease or indeterminate colitis.
- Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
- Severe UC, defined as total Mayo score \>10.
- Not currently in an active phase or flare, defined as a total Mayo score \<4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.
- Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).
- Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).