Status:
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
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
5-17 years
Phase:
PHASE4
Brief 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 remis...
Eligibility Criteria
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.
- 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
- 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).
- NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.
- Evidence or history of toxic megacolon or bowel resection.
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04314375
Start Date
September 29 2023
End Date
June 1 2027
Last Update
September 16 2025
Active Locations (4)
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1
Bausch Health Site 008
Garden Grove, California, United States, 92845
2
Bausch Health Site 003
Indianapolis, Indiana, United States, 46202
3
Bausch Health Site 006
The Bronx, New York, United States, 10467
4
Bausch Health Site 010
Greenville, North Carolina, United States, 27834