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 now · Phase 4 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT04314375

Run by

Bausch Health Americas, Inc.

People needed

70

Starts

2023-09-29

Expected to finish

2027-06-01

Last updated by the study team

2025-09-16

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch Health Site 008 — Garden Grove, California, United States (enrolling)
• Bausch Health Site 003 — Indianapolis, Indiana, United States (enrolling)
• Bausch Health Site 006 — The Bronx, New York, United States (enrolling)
• Bausch Health Site 010 — Greenville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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