Actively Recruiting
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
Led by Bausch Health Americas, Inc. · Updated on 2025-09-16
70
Participants Needed
4
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of ulcerative colitis based on clinical history, characteristic endoscopic findings, and biopsy histopathology
- Age between 5 and 17 years inclusive at screening
- Weigh greater than 13.6 kg at baseline
- Active mild to moderate ulcerative colitis with total Mayo score 4 to 10, rectal bleeding subscore 21 1, stool frequency subscore 21, and endoscopy subscore 21
- Stable dose and formulation of oral or rectal 5-aminosalicylate (5-ASA) for at least 6 weeks prior to randomization and willingness to continue during the study
You will not qualify if you...
- Current or prior diagnosis of Crohn's disease or indeterminate colitis
- Disease limited to distal proctitis involving 15 centimeters or less from the anal verge
- Severe ulcerative colitis with total Mayo score greater than 10
- Not in active flare phase, defined as total Mayo score less than 4 or Mayo subscore of 0 for rectal bleeding, stool frequency, or endoscopy
- Infectious colitis at screening or within 30 days prior to screening
- Prior gastrointestinal surgery except appendectomy or hernia repair (cholecystectomy allowed if over 1 year prior)
- History or evidence of toxic megacolon or bowel resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Bausch Health Site 008
Garden Grove, California, United States, 92845
Actively Recruiting
2
Bausch Health Site 003
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Bausch Health Site 006
The Bronx, New York, United States, 10467
Actively Recruiting
4
Bausch Health Site 010
Greenville, North Carolina, United States, 27834
Actively Recruiting
Research Team
S
Sandra Narain
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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